1. PSYCHOSOCIAL, PSYCHOLOGICAL AND

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1 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS 1. PSYCHOSOCIAL, PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS Table of contents 1. PSYCHOSOCIAL, PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS Table of contents List of tables METHOD Research questions Criteria for determining study eligibility...6 Q15, Q16 and Q17: Interventions for women at risk of developing a mental health disorder...6 Q18, Q19 and Q20: Interventions for women diagnosed with a mental health disorder Literature search methodology Assessment of study eligibility...13 Interventions for women at risk of developing a mental health disorder...13 Interventions for women diagnosed with a mental health disorder Included citations...15 Interventions for women at risk of developing a mental health disorder...15 Interventions for women diagnosed with a mental health disorder...16 Mother-infant interactions Structure Appraisal of included studies...22 Dimensions of evidence...22 Data extraction...24 Data synthesis Limitations of the review methodology PSYCHOSOCIAL, PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS IN WOMEN AT RISK OF DEVELOPING MENTAL HEALTH DISORDER Q15: For women identified as being at risk of developing a mental health disorder in the antenatal or postnatal period, what are the benefits of psychosocial or psychological interventions?...27 Non-pharmacological prevention: women with risk factors...28 Non-pharmacological prevention: women with no identified risk factors Q16: For women identified as being at risk of developing a mental health disorder in the antenatal or postnatal period, what are the benefits of combined psychosocial, psychological and pharmacological interventions? Q17: For women identified as being at risk of developing a mental health disorder in the antenatal or postnatal period, what are the benefits of pharmacological interventions?...70 Pharmacological interventions for the prevention of severe mental disorder for women with no specific risk factors...70 Pharmacological prophylaxis of depression (in women with a past history of depression)...71 Pharmacological interventions for the prophylaxis of severe mental disorder (in women with a past history of bipolar and schizoaffective disorder)

2 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS 1.4. PSYCHOSOCIAL, PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS IN WOMEN WITH A MENTAL HEALTH DISORDER Q18: For women with a mental health disorder in the antenatal or postnatal period, what are the benefits of psychosocial or psychological interventions?...73 Psychosocial and psychological treatments versus standard care...74 Psychosocial and psychological treatments versus other treatments...82 Physical non-pharmacological treatments versus other treatments Q19: For women with a mental health disorder in the antenatal or postnatal period, what are the benefits of combined psychosocial, psychological and pharmacological interventions? Q20: For women with a mental health disorder in the antenatal or postnatal period, what are the benefits of pharmacological interventions? MOTHER-INFANT INTERACTION OR CHILD-RELATED OUTCOMES...98 Interventions to improve the mother-infant interaction where the mother had a mental health disorder...98 Interventions focussing on treatment or prevention of maternal symptoms and reporting mother-infant outcomes

3 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS List of tables Table 1.1 Clinical questions included in this section of the report...5 Table 1.2 Table 1.3 Criteria for determining study eligibility: Interventions for women at risk of developing a mental health disorder...7 Criteria for determining study eligibility: Interventions for women diagnosed with a mental health disorder...8 Table 1.4 Search strategy for intervention clinical questions...8 Table 1.5 Exclusion criteria: Interventions for women at risk of developing a mental health disorder...13 Table 1.6 Exclusion criteria: : Interventions for women diagnosed with a mental health disorder...14 Table 1.7 Assessment of study eligibility: Excluded and included citations for updated interventions search Table 1.8 Table 1.9 Included citations for interventions for women at risk of developing a mental health disorder...15 Included citations for interventions for women diagnosed with a mental health disorder...16 Table 1.10 Included citations for mother infant interactions...17 Table 1.11 Headings in NICE review and relevance to this systematic literature review...18 Table 1.12 Classification of interventions...20 Table 1.13 NHMRC Dimensions of evidence...22 Table 1.14 NHMRC Interim Levels of Evidence (NHMRC 2005) for evaluating intervention and diagnostic accuracy studies...23 Table 1.15 Quality criteria for different levels of evidence...24 Table 1.16 Table 1.17 Reporting biases in systematic reviews...25 Q15: Characteristics of included studies psychological and psychosocial interventions for prevention of mental health disorder versus standard care (risk factors identified)...30 Table 1.18 Q15: Results from Austin Table 1.19 Q15: Results from Munoz Table 1.20 Q15: Results from Vieten Table 1.21 Q15: Results from Dennis Table 1.22 Q15: Results from Melnyk Table 1.23 Q15: Results from Daley 2008b...44 Table 1.24 Q15: Results from Heh Table 1.25 Q15: Results from Barnet Table 1.26 Q15: Results from Hiscock Table 1.27 Q15: Results from Koh Table 1.28 Q15: Characteristics of included studies two or more non pharmacological interventions for prevention of mental disorder (risk factors identified)...50 Table 1.29 Q15: Results from O Higgins Table 1.30 Q15: Results from Tezel 2006 (continuous outcomes)...52 Table 1.31 Q15: Results from Tezel 2006 (dichotomous outcomes)

4 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Table 1.32 Q15: Characteristics of included studies psychological and psychosocial interventions for prevention of mental health disorder versus standard care (no risk factors identified)...57 Table 1.33 Q15: Results from Feinberg Table 1.34 Q15: Results from Jareethum Table 1.35 Q15: Results from Selkirk Table 1.36 Q15: Results from Chang Table 1.37 Q15: Results from Feijo Table 1.38 Q15: Results from Fujita Table 1.39 Q15: Results from Imura 2006 (State Anxiety)...65 Table 1.40 Q15: Results from Imura 2006 (Profile of Mood States)...66 Table 1.41 Table 1.42 Q18: Results from Cuijpers Summary of characteristics of additional studies not included in the NICE review...76 Q18: Characteristics of included studies psychological and psychosocial interventions for treatment of a mental health disorder...78 Table 1.43 Q18: Results from Cho Table 1.44 Q18: Results from Rahman Table 1.45 Q18: Characteristics of included studies physical interventions for treatment of a mental health disorder...86 Table 1.46 Q18: Results from Field Table 1.47 Q19: Characteristics of included studies non pharmacological and pharmacological (mixed) interventions for treatment of a mental health disorder...89 Table 1.48 Q19: Results from Freeman Table 1.49 Q19: Results from Rojas Table 1.50 Q20: Characteristics of included studies pharmacotherapy...94 Table 1.51 Q17: Results from Yonkers Table 1.52 Q20: Results from Rees Table 1.53 Q20: Results from Corral Table 1.54 Mother infant interactions: Characteristics of included studies focussed on mother infant interventions...99 Table 1.55 Mother infant intervention: Results from van Doesum Table 1.56 Table 1.57 Table 1.58 Mother infant interactions: Study characteristics for trials included in Poobalan 2007 systematic review but not in the NICE review Mother infant interventions: Characteristics of studies focussing on treatment or prevention of maternal symptoms and reporting mother infant outcomes women without a diagnosed mental health disorder Mother infant interventions: Characteristics of studies focussing on treatment or prevention of maternal symptoms and reporting mother infant outcomes women with a diagnosed mental health disorder Table 1.59 Mother infant interactions Results from Forman

5 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS 1.2. METHOD Research questions This section of the report covers the six clinical questions which relate to psychosocial, psychological and pharmacological interventions. As shown in Table 1.1, clinical questions 15 to 17 relate to the use of interventions in women at risk of development of a mental health disorder and clinical questions 18 to 20 relate to the use of interventions in women with a mental health disorder. These clinical questions were addressed by updating the relevant clinical questions from the NICE antenatal and postnatal mental health systematic review 1. The NICE review included literature published up until September Therefore the updated literature search was restricted to literature published in 2006 or later in order to capture all new publications. The following mental health disorders were selected for inclusion in this systematic literature review: depression, anxiety disorder, puerperal psychosis and bipolar disorder. In the context of this review, the term perinatal depression and related disorders refers to these four conditions only. Table 1.1 Clinical questions included in this section of the report ID Clinical question Psychosocial, psychological and pharmacological interventions in women at risk of developing mental health disorder Q15a: For women identified as being at risk of developing depression in the antenatal or postnatal period, what are the benefits of psychosocial and psychological interventions? Q15 Q15b: As above, but for anxiety Q15c: As above, but for puerperal psychosis Q15d: As above, but for bipolar disorder Q16a: For women identified as being at risk of developing depression in the antenatal or postnatal period, what are the benefits of combined psychosocial, psychological and pharmacological interventions? Q16 Q16b: As above, but for anxiety Q16c: As above, but for puerperal psychosis Q16d: As above, but for bipolar disorder Q17a: For women identified as being at risk of developing depression in the antenatal or postnatal period, what are the benefits of pharmacological interventions? Q17 Q17b: As above, but for anxiety Q17c: As above, but for puerperal psychosis Q17d: As above, but for bipolar disorder Psychosocial, psychological and pharmacological interventions in women with a mental health disorder Q18a: For women with depression in the antenatal or postnatal period, what are the benefits of psychosocial and psychological interventions? Q18 Q18b: As above, but for anxiety Q18c: As above, but for puerperal psychosis Q18d: As above, but for bipolar disorder Q19a: For women with depression in the antenatal or postnatal period, what are the benefits of combined psychosocial and pharmacological interventions? Q19 Q19b: As above, but for anxiety Q19c: As above, but for puerperal psychosis Q19d: As above, but for bipolar disorder Q20a: For women with depression in the antenatal or postnatal period, what are the benefits of pharmacological interventions? Q20 Q20b: As above, but for anxiety Q20c: As above, but for puerperal psychosis Q20d: As above, but for bipolar disorder 1 5

6 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Criteria for determining study eligibility Q15, Q16 and Q17: Interventions for women at risk of developing a mental health disorder The criteria for study eligibility are shown in Table 1.2. Studies were restricted to randomised controlled trials which recruited pregnant women and women up to 1 year postnatally. Publications were restricted to those evaluating interventions in women who were considered to be risk of future development of a mental health disorder. This included i) women who had undergone some form of screening or evaluation and been classified as having an increased risk of developing a mental health disorders but who did not have a current diagnosis of a mental health disorder at the time of study entry, and ii) women who had not had any form of screening or evaluation performed for a mental health disorder. Any study which evaluated an intervention in women diagnosed with a mental health disorder at study entry was excluded (however, note that these publications met the inclusion criteria for Q18 Q20). Women who had a previous episode of a mental health disorder but did not have a current diagnosis were classified as being at risk. Studies were included if they evaluated any psychosocial, psychological or pharmacological intervention. Studies which evaluated psychosocial or psychological interventions were considered relevant to Q15, studies which evaluated pharmacological interventions were considered relevant to Q16 and studies which evaluated combined psychosocial, psychological and pharmacological interventions were considered relevant to Q17. Studies were not excluded on the basis of the comparator used. The outcomes specifically extracted in the NICE review were listed as i) number depressed at endpoint as defined by the study (based on EPDS, Hamilton rating scale for depression or BDI score, or on presence of depression according to a diagnostic tool), ii) leaving the study early for any reason or iii) continuous scores on depression rating scales. However, the NICE review only used continuous data in a selection of analyses. NICE did not find a significant number of publications that evaluated interventions for anxiety, puerperal psychosis or bipolar disorder, hence the outcomes reported by them focussed on depression. As the updated literature search may have identified studies of interventions in these other mental health disorders, the outcomes extracted were modified slightly. Publications were included if they reported i) the number of patients with the mental health disorder at the study endpoint (as defined by an appropriate diagnostic tool), ii) the number leaving the study or any reason or iii) continuous scores (using an appropriate rating scale). The NICE review extracted data on the number of subjects who left the study for any reason. The reason why subjects left the study were also extracted in the updated literature search. Outcomes related to mother-child interactions were not listed as a specific outcome in the NICE review inclusion criteria, however mother-child interactions and child-related outcomes were discussed in detail in Section 6.11 of the NICE review. For clarity, these outcomes have been included in Table 1.2 and were extracted with the effectiveness outcomes. 6

7 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Table 1.2 Criteria for determining study eligibility: Interventions for women at risk of developing a mental health disorder Study design Randomised controlled trials and systematic reviews of randomised controlled trials Population Pregnant women and women up to 1 year postnatally who did not have a diagnosis of depression, anxiety, puerperal psychosis or bipolar disorder at the time of study entry a Tool Q15: A psychosocial or psychological intervention Q16: A combination of psychosocial, psychological and pharmacological interventions Q17: A pharmacological intervention Comparator Any Outcomes Number with mental health disorder at endpoint, as defined by an appropriate diagnostic tool Number leaving the study early for any reason and the reason why they left the study Continuous scores using an appropriate rating scale Mother-child interaction or child-related outcomes b a Including women with no risk factors and women with a prior diagnosis of a mental health disorder who were not experiencing an episode of that mental health disorder at the time of study entry b Not included as a specific outcome in the NICE review, however these outcomes were extracted and discussed in Section 6.11 of the NICE review and were included here at the request of GEAC Q18, Q19 and Q20: Interventions for women diagnosed with a mental health disorder The criteria for study eligibility are shown in Table 1.3. Studies were restricted to randomised controlled trials which recruited pregnant women and women up to 1 year postnatally. Publications were restricted to those evaluating interventions in women who had been diagnosed with a mental health disorder at the time of study entry. Studies were included if they evaluated any psychosocial, psychological or pharmacological intervention. Studies which evaluated psychosocial or psychological interventions were considered relevant to Q18, studies which evaluated pharmacological interventions were considered relevant to Q19 and studies which evaluated combined psychosocial, psychological and pharmacological interventions were considered relevant to Q20. Studies were not excluded on the basis of the comparator used. As discussed for Q15, Q16 and Q17, the outcomes specifically extracted in the NICE review were based on depression. For this systematic review, publications were included if they reported i) the number of patients with the mental health disorder at the study endpoint (as defined by an appropriate diagnostic tool), ii) the number leaving the study or any reason, iii) continuous scores (using an appropriate rating scale) or iv) recurrence of the mental health disorder. As discussed for Q15, Q16 and Q17, mother-child interactions and child-related outcomes were not listed as a specific eligibility criteria in the NICE review, despite being discussed in detail. Therefore, these outcomes have been included in Table

8 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Table 1.3 Criteria for determining study eligibility: Interventions for women diagnosed with a mental health disorder Study design Randomised controlled trials and systematic reviews of randomised controlled trials Population Pregnant women and women up to 1 year postnatally who had been diagnosed with depression, anxiety, puerperal psychosis or bipolar disorder at the time of study entry Tool Q18: A psychosocial or psychological intervention Q19: A combination of psychosocial, psychological and pharmacological interventions Q20: A pharmacological intervention (including complementary medicines) Comparator Any Outcomes Number with mental health disorder at endpoint, as defined by an appropriate diagnostic tool Number leaving the study early for any reason and the reason why they left the study Continuous scores using an appropriate rating scale Recurrence of mental health disorder Mother-child interaction or child-related outcomes a a Not included as a specific outcome in the NICE review, however these outcomes were extracted and discussed in Section 6.11 of the NICE review and were included here at the request of GEAC Literature search methodology A systematic method of literature searching and selection was employed in the preparation of this review. Searches were conducted in EMBASE, Medline, PsycInfo, CINAHL and the Cochrane Database of Systematic Review. The literature search was restricted to citations published after Search terms were entered as keywords, exploded where possible, and as free text within the title and/or abstract, in the EMBASE and Medline databases. Variations on these terms were used for the Cochrane library, PsycInfo and CINAHL searches after modifications were made to suit the keywords and descriptors of each search platform. The reference lists of included papers were reviewed to identify any peer-reviewed evidence that may have been missed in the literature search. Contacting of authors for unpublished research was not undertaken in this review. Conference abstracts were not eligible for inclusion. The searches were conducted between 2 February 2009 and 12 March Therefore, studies published after this time were not eligible for inclusion in the systematic review. The search strategy is shown in Table 1.4. A total of 2,534 non-duplicate citations were identified. Table 1.4 Search strategy for intervention clinical questions Database EMBASE + Medline a Date searched Feb 2009 # Search terms Citations 1 pregnan* 584,142 2 matern* 189,202 3 antepart* 4,178 4 postpart* 27,292 5 prenat* 120,091 6 antenatal* 19,488 7 perinatal* 71,935 8 peripart* 2,837 9 postnatal* 69, 'puerperal'/exp OR 'puerperal' 36, #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 803, 'anxiety disorder'/exp 89, 'mixed anxiety and depression'/de 'depression'/exp 202, 'atypical depression'/de 'major depression'/de 12, 'bipolar disorder'/exp 26, ((bipolar:ti OR 'bi polar':ti) AND (disorder*:ti OR depress*:ti)) 7,742 8

9 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Database Date searched # Search terms Citations 19 ((bipolar:ab OR 'bi polar':ab) AND (disorder*:ab OR depress*:ab)) 14, 'bipolar depression'/de 1, 'bipolar mania'/de 'mixed mania and depression'/de mania:ti,ab OR manic:ti,ab OR hypomania:ti,ab 12, 'anxiety'/de 69, anxious:ti,ab OR anxiety:ti,ab OR panic:ti,ab 94, 'psychosis'/exp 150, 'puerperal psychosis'/de 'manic depressive psychosis'/de 8, 'manic psychosis'/de psychos*:ti,ab OR psychotic*:ti,ab 106, ((attach*:ti OR bond:ti OR bonding:ti) AND (ambivalent:ti OR anxious*:ti OR avoid*:ti OR difficult*:ti OR disinhibit*:ti OR disorder*:ti OR disorganis*:ti OR disruptiv*:ti OR dissociat*:ti OR dysregula*:ti OR disorientat*:ti OR 1,657 disturbance*:ti OR impair*:ti OR inadequate:ti OR inhibit*:ti OR injur*:ti OR insecur*:ti OR poor:ti OR style*:ti)) 32 ((attach*:ab OR bond:ab OR bonding:ab) AND (ambivalent:ab OR anxious*:ab OR avoid*:ab OR difficult*:ab OR disinhibit*:ab OR disorder*:ab OR disorganis*:ab OR disruptiv*:ab OR dissociat*:ab OR dysregula*:ab OR 39,574 disorientat*:ab OR disturbance*:ab OR impair*:ab OR inadequate:ab OR inhibit*:ab OR injur*:ab OR insecur*:ab OR poor:ab OR style*:ab)) 33 #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR 530,768 #30 OR #31 OR #32 34 #11 AND #33 21, 'meta analysis'/exp OR 'meta analysis' 51, 'systematic review'/exp OR 'systematic review' 35, 'pooled analysis' 1, 'review'/exp OR 'review' 2,057, systemat* 173, pool* 103, #35 OR #39 OR #40 299, #38 AND #41 85, #35 OR #36 OR #37 OR #42 105, #34 AND # 'comparative study'/exp 835, 'randomized controlled trial'/exp 214, 'crossover procedure'/exp 25, 'double blind procedure'/exp 90, 'parallel design'/exp 1, 'single blind procedure'/exp 10, 'placebo'/exp OR 'placebo' 209, controlled 3,143, comparative 802, 'open label' 13, 'double *1 blind' 128, 'single *1 blind' 14, randomi* 380, double AND dummy 1, #45 OR #46 OR #47 OR #48 OR #49 OR #50 OR #51 OR #52 OR #53 OR #54 OR #55 OR #56 OR #57 OR #58 4,097, #34 AND #59 6, #44 AND [ ]/py #60 AND [ ]/py 2, #61 OR #62 2,417 9

10 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Database PsycInfo Date searched Mar Week # Search terms Citations 64 #63 AND [english]/lim 2, #64 AND [humans]/lim 1, #64 AND [animals]/lim #64 NOT #66 1, #65 OR #67 1,809 1 exp Pregnancy/ 11,298 2 pregnan$.mp. 22,398 3 matern$.mp. 29,853 4 antepart$.mp postpart$.mp. 5,514 6 prenat$.mp. 12,035 7 antenatal$.mp. 1,079 8 perinatal$.mp. 4,529 9 peripart$.mp postnatal$.mp. 9, puerperal.mp or/ , exp Anxiety Disorders/ 43, exp major depression/ 62, atypical depression/ exp Bipolar Disorder/ 12, ((bipolar or bi polar) and (disorder$ or depress$)).ti. 5, ((bipolar or bi polar) and (disorder$ or depress$)).ab. 13, (mania or manic or hypomania).ti,ab. 13, exp Anxiety/ 37, (anxious or anxiety or panic).ti,ab. 103, exp psychosis/ 72, exp Postpartum Psychosis/ (psychos$ or psychotic$).ti,ab. 98, ((attach$ or bond or bonding) and (ambivalent or anxious$ or avoid$ or difficult$ or disinhibit$ or disorder$ or disorganis$ or disruptiv$ or dissociat$ or dysregula$ or disorientat$ or disturbance$ or impair$ or inadequate or inhibit$ or injur$ or 1,823 insecur$ or poor or style$)).ti. 26 ((attach$ or bond or bonding) and (ambivalent or anxious$ or avoid$ or difficult$ or disinhibit$ or disorder$ or disorganis$ or disruptiv$ or dissociat$ or dysregula$ or disorientat$ or disturbance$ or impair$ or inadequate or inhibit$ or injur$ or 10,489 insecur$ or poor or style$)).ab. 27 ((bipolar or bi polar) and (disorder$ or depress$)).id. 9, (mania or manic or hypomania).id. 6, (anxious or anxiety or panic).id. 51, ((attach$ or bond or bonding) and (ambivalent or anxious$ or avoid$ or difficult$ or disinhibit$ or disorder$ or disorganis$ or disruptiv$ or dissociat$ or dysregula$ or disorientat$ or disturbance$ or impair$ or inadequate or inhibit$ or injur$ or 2,901 insecur$ or poor or style$)).id. 31 or/ , and 12 12, meta analysis.mp. 8, systematic review.mp. 2, pooled analysis.mp review.mp. 193, systemat$.mp. 50, pool$.mp. 8, or 33 or 37 64, and 36 10, or 33 or 34 or 40 16, and

11 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Database Date searched CINAHL Mar 2009 # Search terms Citations 43 comparative study.mp. 7, randomized controlled trial.mp. 3, clinical trials/ 2, crossover procedure.mp double blind procedure.mp parallel design.mp single blind procedure.mp exp Placebo/ 2, placebo.mp. 21, controlled.mp. 50, comparative.mp. 30, open label.mp. 2, (double adj1 blind).mp. 12, (single adj1 blind).mp randomi$.mp. 22, (double and dummy).mp or/ , and limit 42 to yr=" " limit 60 to yr=" " or/ limit 63 to english language limit 64 to human limit 64 to animal not or S1 (MH "Pregnancy+") 61,628 S2 TX pregnan* 67,184 S3 TX matern* 30,269 S4 TX antepart* 626 S5 TX postpart* 5,881 S6 TX prenat* 15,244 S7 TX antenatal* 2,638 S8 TX perinatal* 12,557 S9 TX peripart* 229 S10 TX postnatal* 6,397 S11 TX puerperal 515 S12 s1 or s2 or s3 or s4 or s5 OR s6 OR s7 OR s8 OR s9 OR s10 OR s11 91,367 S13 (MH "Anxiety Disorders+") 8,926 S14 (MH "Depression+") 25,400 S15 (MH "Bipolar Disorder+") 2,347 S16 TI ( bipolar or bi polar ) and TI ( disorder* or depress* ) 1,013 S17 AB ( bipolar or bi polar ) and AB ( disorder* or depress* ) 1,114 S18 TI ( mania or manic or hypomania ) or AB ( mania or manic or hypomania ) 763 S19 (MH "Anxiety+") 8,818 S20 TI ( anxious or anxiety or panic ) or AB ( anxious or anxiety or panic ) 15,433 S21 (MH "Psychotic Disorders+") 30,271 S22 TI ( psychos* or psychotic* ) or AB ( psychos* or psychotic* ) 17,775 S23 TI ( attach* or bond or bonding ) and TI ( ambivalent or anxious* or avoid* or difficult* or disinhibit* or disorder* or disorganis* or disruptiv* or dissociat* or dysregula* or disorientat* or disturbance* or impair* or inadequate or inhibit* or injur* or insecur* or poor or style* )

12 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Database Cochrane Library Date searched Feb 2009 # Search terms Citations S24 AB ( attach* or bond or bonding ) and AB ( ambivalent or anxious* or avoid* or difficult* or disinhibit* or disorder* or disorganis* or disruptiv* or dissociat* or dysregula* or disorientat* or disturbance* or impair* or inadequate or inhibit* or injur* or insecur* or poor or style* ) S25 s13 OR s14 OR s15 OR s16 OR s17 OR s18 OR s19 OR s20 OR s21 OR s22 or s23 or s24 87,200 S26 s12 AND s S27 (MH "Meta Analysis") 7,618 S28 (MH "Systematic Review") 4,389 S29 (MH "Cochrane Library") 3,272 S30 TX "pooled analysis" 363 S31 TX "review" 189,683 S32 TX systemat* 30,584 S33 TX pool* 7,254 S34 s27 OR s32 OR s33 39,056 S35 s31 AND s34 23,403 S36 s27 OR s28 OR s29 OR s30 OR s35 26,008 S37 s26 AND s S38 (MH "Comparative Studies") 48,221 S39 (MH "Clinical Trials+") 71,700 S40 TX "crossover procedure" 1 S41 (MH "Double-Blind Studies") 12,824 S42 TX "parallel design" 104 S43 (MH "Single-Blind Studies") 3,366 S44 (MH "Placebos") 5,011 S45 TX placebo 14,836 S46 TX controlled 42,857 S47 TX comparative 57,222 S48 TX open label 2,209 S49 TX double w1 blind 394,185 S50 TX single w1 blind 3,643 S51 TX randomi* 46,987 S52 TX double AND dummy 275 S53 s38 OR s39 OR s40 OR s41 OR s42 OR s43 OR s44 OR s45 OR s46 OR s47 OR s48 OR s49 OR s50 OR s51 OR s52 509,857 S54 s26 AND s53 1,772 S55 s37 OR s54 1,850 S56 s37 OR s54 Limiters - Published Date from: (pregnan* OR matern* OR antepart* OR postpart* OR prenat* OR antenatal * OR Perinatal* OR peripart* OR puerperal) 23,988 2 (depression OR anxiety OR bipolar OR psychosis) ,543 3 (#3 AND #4) Restricted to 2006 to Manual search 2 Total number of citations 3,021 Total number of non-duplicate citations 2,532 a The extensive search functionality of EMBASE.com was used in particular instances eg for the pregnancy-related terminology (#1-#10 of the EMBASE search). This means that each search term was mapped to EMTREE and that the search was carried out on the preferred EMTREE term; ie, the search was carried out on the index term field of each record. In addition, the search term was added to the search and searched as a text word in all fields of each record. Where the search term could not be matched to EMTREE, the search was performed just on the search term across all fields of each record. 12

13 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Assessment of study eligibility Interventions for women at risk of developing a mental health disorder Publications identified in the literature search were reviewed and the exclusion criteria shown in Table 1.5 applied hierarchically. Publications were excluded if they were the wrong study type (not an RCT), if they were in the wrong population (not in pregnant or up to one year postpartum women without a diagnosis of a mental health disorder) or evaluated the wrong intervention (not a psychosocial, pharmacological or combined intervention designed to improve mental health disorder outcomes). Publications were excluded if they reported the wrong outcomes (not the number with the mental health disorder at study endpoint, number leaving the study, continuous severity scores or mother-child/child-related outcomes). Only English language publications were eligible for inclusion. Table 1.5 Exclusion criteria: Interventions for women at risk of developing a mental health disorder Wrong study type Wrong population Wrong intervention Wrong outcome Not in English Excludes any publication that does not report results of an RCT: eg non-systematic reviews, case reports, animal studies, short notes, letters, editorials, conference abstracts, in-vitro studies, cohort studies Not in pregnant women or women up to 1 year postnatally who did not have a diagnosis of depression, anxiety, puerperal psychosis or bipolar disorder at the time of study entry Does not evaluate a psychological, psychosocial or non-pharmacological physical treatment which aims to improve depression, anxiety, puerperal psychosis or bipolar outcomes during pregnancy or postnatally Does not report the following outcomes: Number with mental health disorder at endpoint, as defined by an appropriate diagnostic tool Number leaving the study early for any reason. Continuous scores using an appropriate rating scale Mother-child interaction or child-related outcomes Non-English publications will not be included Interventions for women diagnosed with a mental health disorder Publications identified in the literature search were reviewed and the exclusion criteria shown in Table 1.6 applied hierarchically. Publications were excluded if they were the wrong study type (not an RCT), if they were in the wrong population (not in pregnant or up to one year postpartum women diagnosed with a mental health disorder) or evaluated the wrong intervention (not a psychosocial, pharmacological or combined intervention designed to improve mental health disorder outcomes). Publications were excluded if they reported the wrong outcomes (not the number with the mental health disorder at study endpoint, number leaving the study, continuous severity scores or mother-child/child-related outcomes). Only English language publications were eligible for inclusion. 13

14 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Table 1.6 Exclusion criteria: : Interventions for women diagnosed with a mental health disorder Wrong study type Wrong population Wrong intervention Wrong outcome Not in English Excludes any publication that does not report results of an RCT: eg non-systematic reviews, case reports, animal studies, short notes, letters, editorials, conference abstracts, in-vitro studies, cohort studies Not in pregnant women or women up to 1 year postnatally diagnosed with of depression, anxiety, puerperal psychosis or bipolar disorder at the time of study entry Does not evaluate a psychological, psychosocial or non-pharmacological physical treatment which aims to improve depression, anxiety, puerperal psychosis or bipolar outcomes during pregnancy or postnatally Does not report the following outcomes: Number with mental health disorder at endpoint, as defined by an appropriate diagnostic tool Number leaving the study early for any reason. Continuous scores using an appropriate rating scale Recurrence of mental health disorder Mother-child interaction or child-related outcomes Non-English publications will not be included A total of 2,534 citations were identified in the initial literature search (shown in Table 1.4). The exclusion criteria was applied to all citations by reviewing the abstract and title, with 2,422 publications excluded (shown in Table 1.7). A total of 110 publications remained, and the full text version of each publication was retrieved and reviewed. The same exclusion criteria were then applied to the full text articles. A total of 50 publications met the inclusion criteria for at least one of the clinical questions related to psychosocial risk assessment tools or case detection tools (Q15-Q20)., or mother-infant interactions. A full list of excluded citations annotated by the key reason for exclusion is shown in Appendix X. Table 1.7 Assessment of study eligibility: Excluded and included citations for updated interventions search Exclusion criteria Number Total citations 2,532 Citations excluded after review of abstract/title Wrong study type Wrong population Wrong intervention Wrong outcome Not in English Total excluded citations 2, ,422 Full papers reviewed: 110 Citations excluded after review of full publication Wrong study type Wrong population Wrong intervention Wrong outcome Not in English Already reviewed by NICE Total excluded citations Total included citations

15 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Included citations Interventions for women at risk of developing a mental health disorder The literature search identified 25 publications which met the inclusion criteria for clinical questions The full citation and the study ID is shown in Table 1.8. The applicability column shows the clinical questions related to each publication. These publications are discussed in Section 1.3 on page 27. Table 1.8 Included citations for interventions for women at risk of developing a mental health disorder Study ID Citation Applicability Austin 2008 Barnet 2007 Beddoe 2008 Chang 2008 Crockett 2008 Daley 2008b Dennis 2008a Dennis 2008b Dennis 2009 Feijo 2006 Feinberg 2008 Fujita 2006 Heh 2008 Hiscock 2007 Hiscock 2008 Imura 2006 Jareethum 2008 Austin MP, Frilingos M, Lumley J, Hadzi PD, Roncolato W, Acland S et al. Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial. J Affective Disord 2008; 105: Barnet B, Liu J, DeVoe M, Alperovitz BK, Duggan AK. Home visiting for adolescent mothers: effects on parenting, maternal life course, and primary care linkage. Ann Fam Med 2007; 5: Beddoe AE, Lee KA. Mind-Body interventions during pregnancy. JOGNN J Obstet Gynecol Neonatal Nurs 2008; 37(2): Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs 2008; 17: Crockett K, Zlotnick C, Davis M, Payne N, Washington R. A depression preventive intervention for rural low-income African-American pregnant women at risk for postpartum depression. Arch Women's Ment Health 2008; 11(5-6): Daley AJ, Winter H, Grimmett C, McGuinness M, McManus R, MacArthur C. Feasibility of an exercise intervention for women with postnatal depression: A pilot randomised controlled trial. Br J Gen Pract 2008; 58(548): Dennis CL, Ross LE, Herxheimer A. Oestrogens and progestins for preventing and treating postpartum depression. Cochrane Database Syst Rev 2008; -(4):CD Dennis CL, Kingston D. A systematic review of telephone support for women during pregnancy and the early postpartum period. JOGNN J Obstet Gynecol Neonatal Nurs 2008; 37(3): Dennis CL, Hodnett E, Kenton L, Weston J, Zupancic J, Stewart DE et al. Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial. BMJ 2009; 338(-):a3064. Feijo L, Hernandez-Reif M, Field T, Burns W, Valley-Gray S, Simco E. Mothers' depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Dev 2006; 29(3): Feinberg ME, Kan ML. Establishing Family Foundations: Intervention Effects on Coparenting, Parent/Infant Well-Being, and Parent-Child Relations. J Fam Psychol 2008; 22(2): Fujita M, Endoh Y, Saimon N, Yamaguchi S. Effect of massaging babies on mothers: Pilot study on the changes in mood states and salivary cortisol level. Complement Ther Clin Pract 2006; 12(3): Heh SS, Huang LH, Ho SM, Fu YY, Wang LL. Effectiveness of an exercise support program in reducing the severity of postnatal depression in Taiwanese women. Birth 2008; 35: Hiscock H, Bayer J, Gold L, Hampton A, Ukoumunne OC, Wake M. Improving infant sleep and maternal mental health: a cluster randomised trial. Arch Dis Child 2007; 92: Hiscock H, Bayer JK, Hampton A, Ukoumunne OC, Wake M. Long-term mother and child mental health effects of a population-based infant sleep intervention: clusterrandomized, controlled trial. Pediatrics 2008; 122(3):e621-e627. Imura M. The psychological effects of aromatherapy-massage in healthy postpartum mothers. J Midwifery Women's Health 2006; 51(2):e21-e27. Jareethum R, Titapant V, Tienthai C, Viboonchart S, Chuenwattana P, Chatchainoppakhun J. Satisfaction of healthy pregnant women receiving short message service via mobile phone for prenatal support: A randomized controlled trial. J Med Assoc Thailand 2008; 91(4): Q15 Q15 Q15 Q15 Q15 Q15 Q17 Q15 Q15 Q15 Q15 Q15 Q15 Q15 Q15 Q15 Q15 15

16 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Koh 2007 Melnyk 2006 Munoz 2007 OHiggins 2008 Petrou 2006 Selkirk 2006 Tezel 2006 Vieten 2008 Koh THHG, Butow PN, Coory M, Budge D, Collie LA, Whitehall J et al. Provision of taped conversations with neonatologists to mothers of babies in intensive care: Randomised controlled trial. Br Med J 2007; 334(7583): Melnyk BM, Feinstein NF, Alpert-Gillis L, Fairbanks E, Crean HF, Sinkin RA et al. Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Pediatrics 2006; 118(5):e1414- e1427. Munoz RF, Le HN, Ippen CG, Diaz MA, Urizar GG, Jr., Soto J et al. Prevention of postpartum depression in low-income women: development of the Mamas y Bebes/Mothers and Babies Course. Cogn Behav Pract 2007; 14: OHiggins M, James Roberts I, Glover V. Postnatal depression and mother and infant outcomes after infant massage. J Affective Disord 2008; 109(1-2): Petrou S, Cooper P, Murray L, Davidson LL. Cost-effectiveness of a preventive counselling and support package for postnatal depression. International journal of technology assessment in health care 2006; 22: Selkirk R, McLaren S, Ollerenshaw A, McLachlan AJ, Moten J. The longitudinal effects of midwife-led postnatal debriefing on the psychological health of mothers. J Reprod Infant Psychol 2006; 24: Tezel A, Gözüm S. Comparison of effects of nursing care to problem solving training on levels of depressive symptoms in post partum women. Patient Educ Couns 2006; 63: Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: Results of a pilot study. Arch Women's Ment Health 2008; 11(1): Q15 Q15 Q15 Q15 Q15 Q15 Q15 Q15 Interventions for women diagnosed with a mental health disorder The literature search identified 22 publications which met the inclusion criteria for clinical questions The full citation and the study ID is shown in Table 1.9. The applicability column shows which clinical questions related to each publication. These publications are discussed in Section 1.4 on page 73. Table 1.9 Included citations for interventions for women diagnosed with a mental health disorder Study ID Citation Applicability Bledsoe 2006 Cho 2008 Cipriani 2007 Coelho 2008 Corral 2007 Cuijpers 2008a Cuijpers 2008b Daley 2007 Daley 2008a Dennis 2007a Bledsoe SE, Grote NK. Treating Depression During Pregnancy and the Postpartum: A Preliminary Meta-Analysis. [References]. Research on Social Work Practice Vol 16 (2) Mar 2006;-120. Cho HJ, Kwon JH, Lee JJ. Antenatal cognitive-behavioral therapy for prevention of postpartum depression: A pilot study. Yonsei Med J 2008; 49(4): Cipriani A, Geddes JR, Furukawa TA, Barbui C. Metareview on short-term effectiveness and safety of antidepressants for depression: An evidence-based approach to inform clinical practice. Can J Psychiatry 2007; 52(9): Coelho HF, Boddy K, Ernst E. A systematic review of classical European massage for alleviating perinatal depression and anxiety. Focus Altern Complement Ther 2008; 13(3): Corral M, Wardrop AA, Zhang H, Grewal AK, Patton S. Morning light therapy for postpartum depression. Arch Women's Ment Health 2007; 10: Cuijpers P, Van Straten A, Warmerdam L, Smits N. Characteristics of effective psychological treatments of depression: A metaregression analysis. Psychother Res 2008; 18(2): Cuijpers P, Brannmark JG, Van Straten A. Psychological treatment of postpartum depression: A meta-analysis. J Clin Psychol 2008; 64(1): Daley AJ, MacArthur C, Winter H. The Role of Exercise in Treating Postpartum Depression: A Review of the Literature. J Midwifery Women's Health 2007; 52(1): Daley A. Exercise and depression: A review of reviews. J Clin Psychol Med Settings 2008; 15(2): Dennis CL, Hodnett E. Psychosocial and psychological interventions for treating postpartum depression. Cochrane Database Syst Rev 2007; -(4):CD Q18 Q18 Q20 Q18 Q20 Q18 Q18 Q18 Q18 Q18 16

17 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Study ID Citation Applicability Dennis 2008a Dennis 2008c Field 2008 Freeman 2008 Leo 2007 Montgomery 2008 Pilkington 2006 Rahman 2008 Rees 2008 Rojas 2007 Vasudev 2008 Yonkers 2008 Dennis CL, Ross LE, Herxheimer A. Oestrogens and progestins for preventing and treating postpartum depression. Cochrane Database Syst Rev 2008; -(4):CD Dennis CL, Giavedoni K. Interventions (other than pharmacological, psychosocial or psychological) for treating antenatal depression. Cochrane Database Syst Rev 2008; -(4). Field T, Figueiredo B, Hernandez-Reif M, Diego M, Deeds O, Ascencio A. Massage therapy reduces pain in pregnant women, alleviates prenatal depression in both parents and improves their relationships. J Bodywork Mov Ther 2008; 12(2): Freeman MP, Davis M, Sinha P, Wisner KL, Hibbeln JR, Gelenberg AJ. Omega-3 fatty acids and supportive psychotherapy for perinatal depression: A randomized placebocontrolled study. J Affective Disord 2008; 110(1-2): Leo RJ, Ligot JS. A systematic review of randomized controlled trials of acupuncture in the treatment of depression (Structured abstract). J Affective Disord 2007; 97: Montgomery P, Richardson AJ. Omega-3 fatty acids for bipolar disorder. Montgomery Paul, Richardson Alexandra J Omega 3 fatty acids for bipolar disorder Cochrane Database of Systematic Reviews: Reviews 2008 Issue 2 John Wiley & Sons, Ltd Chichester, UK DOI : / CD pub Pilkington K, Boshnakova A, Richardson J. St John's wort for depression: Time for a different perspective? Complement Ther Med 2006; 14(4): Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet 2008; 372(9642): Rees AM, Austin MP, Parker GB. Omega-3 fatty acids as a treatment for perinatal depression: Randomized double-blind placebo-controlled trial. Aust New Zealand J Psychiatry 2008; 42(3): Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez M et al. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet 2007; 370(9599): Vasudev A, Macritchie K, Watson S, Geddes J, Young AH. Oxcarbazepine in the maintenance treatment of bipolar disorder. Oxcarbazepine in the maintenance treatment of bipolar disorder Cochrane Database of Systematic Reviews: Reviews 2008 Issue 1 John Wiley & Sons, Ltd Chichester, UK DOI : Yonkers KA, Lin H, Howell HB, Heath AC, Cohen LS. Pharmacologic treatment of postpartum women with new-onset major depressive disorder: A randomized controlled trial with paroxetine. J Clin Psychiatry 2008; 69(4): Q20 Q18 Q18 Q19 Q18 Q20 Q20 Q18 Q20 Q19 Q20 Q20 Mother-infant interactions The literature search identified 10 publications which reported outcomes related to mother-infant interactions. The full citation and the study ID is shown in Table These publications are discussed in Section 1.5 on page 98. Table 1.10 Included citations for mother-infant interactions Study ID Citation Applicability Feinberg 2008 Forman 2007 Hiscock 2007 Hiscock 2008 Feinberg ME, Kan ML. Establishing Family Foundations: Intervention Effects on Coparenting, Parent/Infant Well-Being, and Parent-Child Relations. J Fam Psychol 2008; 22(2): Forman DR, O'Hara MW, Stuart S, Gorman LL, Larsen KE, Coy KC. Effective treatment for postpartum depression is not sufficient to improve the developing motherchild relationship. Dev Psychopathol 2007; 19: Hiscock H, Bayer J, Gold L, Hampton A, Ukoumunne OC, Wake M. Improving infant sleep and maternal mental health: a cluster randomised trial. Arch Dis Child 2007; 92: Hiscock H, Bayer JK, Hampton A, Ukoumunne OC, Wake M. Long-term mother and child mental health effects of a population-based infant sleep intervention: clusterrandomized, controlled trial. Pediatrics 2008; 122(3):e621-e627. Mother-infant interactions Mother-infant interactions Mother-infant interactions Mother-infant interactions 17

18 PSYCHOLOGICAL AND PHARMACOLOGICAL INTERVENTIONS (Q15 20): METHODS Study ID Citation Applicability Imura 2006 Melnyk 2006 O Higgins 2008 Poobalan 2007 Rahman 2008 Van Doesum 2008 Imura M. The psychological effects of aromatherapy-massage in healthy postpartum mothers. J Midwifery Women's Health 2006; 51(2):e21-e27. Melnyk BM, Feinstein NF, Alpert-Gillis L, Fairbanks E, Crean HF, Sinkin RA et al. Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Pediatrics 2006; 118(5):e1414- e1427. OHiggins M, James Roberts I, Glover V. Postnatal depression and mother and infant outcomes after infant massage. J Affective Disord 2008; 109(1-2): Poobalan AS, Aucott LS, Ross L, Smith WCS, Helms PJ, Williams JHG. Effects of treating postnatal depression on mother-infant interaction and child development: Systematic review. Br J Psychiatry 2007; 191(NOV.): Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet 2008; 372(9642): Van Doesum KTM, Riksen-Walraven JM, Hosman CMH, Hoefnagels C. A randomized controlled trial of a home-visiting intervention aimed at preventing relationship problems in depressed mothers and their infants. Child Dev 2008; 79(3): Mother-infant interactions Mother-infant interactions Mother-infant interactions Mother-infant interactions Mother-infant interactions Mother-infant interactions Structure Clinical questions were addressed by updating eight sections of the NICE review. These are shown in Table The headings cover pharmacological and non-pharmacological interventions used for the prevention or treatment of a mental health disorder. The section on mother-infant interactions or child-relation outcomes was also included in the updated literature search as this was an area of specific interest to the GEAC. See Appendix X for further information regarding the NICE review. Table 1.11 Headings in NICE review and relevance to this systematic literature review NICE heading 1. Non-pharmacological prevention: women with risk factors 2. Non-pharmacological prevention: women with no risk factors 3. Non-pharmacological treatment: treatment vs standard care 4. Non-pharmacological treatment: treatments vs other treatments 5. Mother-infant interaction or child-related outcomes 6. Pharmacological prevention 7. Physical or pharmacological treatment 8. Pharmacological prophylaxis As this section of the systematic literature review was an update of the NICE review, the interventions identified in the updated literature search were categorised according to the criteria used in NICE. This is shown in Table Two sections of the NICE review were considered relevant to clinical question 15 (For women at risk of developing a mental health disorder, what psychosocial interventions are most effective at reducing that risk?). These two sections were Non-pharmacological prevention: women with risk factors (Section 1 of the NICE review) and Non-pharmacological prevention: women with no risk factors (Section 2). The interventions identified by NICE are shown in the third column, with the interventions identified by the updated literature search shown in the fourth column. It is noted that the updated literature search for psychosocial interventions for the prevention of mental health disorders (Q15) includes physical interventions of exercise and massage, which were not identified in the NICE review. Additionally, some of the definitions used by NICE may not be the same as those used in the Australian setting. For example, NICE section 7 (Physical or pharmacological treatments) included light therapy, oestrogen and antidepressants. This section was included under Q20, which relates to pharmacological interventions. Although interventions such as light therapy could be considered a non-pharmacological 18