updated 2012 Relaxatin training Q 5: Is relaxatin training better (mre effective than/as safe as) than treatment as usual in adults with depressive episde/disrder? Backgrund The number f general health staff skilled in psychlgical treatment fr depressin is limited, and learning psychlgical treatments tends t require cnsiderable training and supervisin. Relaxatin may be a relatively simple frm f psychlgical treatment. It has been frequently studied in research studies as an active cnditin and as a cntrl cnditin. Ppulatin/Interventin(s)/Cmparisn/Outcme(s) (PICO) Ppulatin: adults with depressive episde/disrder Interventins: relaxatin training Cmparisn: treatment as usual Outcmes: symptm severity pst interventin functining pst interventin symptm severity at 6 t 12 mnths fllw-up adverse effects (including tlerability) List f the systematic reviews identified by the search prcess INCLUDED IN GRADE TABLES OR FOOTNOTES 1
Jrm AF, Mrgan AJ, Hetrick SE (2008). Relaxatin fr depressin. Cchrane Database f Systematic Reviews, (4):CD007142. EXCLUDED FROM GRADE TABLES AND FOOTNOTES Other than a review specifically n Yga (Pilkingtn et al, 2005), there was n ther recent, relevant review. We checked PubMed, NICE and BMJ Clinical Evidence as well as the references in the selected Cchrane review. The nly ther related reviews (with an lder date) are dne by the same first authr f the selected Cchrane review, i.e.: Jrm AF et al (2002) Effectiveness f cmplementary and self-help treatments fr depressin. Medical Jurnal f Australia, 176:S84 96. PICO Table Serial n. Interventin/Cmparisn Outcmes Systematic reviews used fr GRADE Explanatin 1 Relaxatin/ usual care symptm severity pst interventin; functining pst interventin; symptm severity at 6 t 12 mnths fllw-up; adverse effects (including tlerability) Jrm et al (2008) The Jrm et al (2008) is a recent Cchrane review that includes bth peer-reviewed as unpublished studies. Narrative descriptin f the studies that went int the analysis The Jrm et al (2008)review cvers 15 trials, which they describe as fllws: Ten f the trials evaluated prgressive muscle relaxatin, ne evaluated autgenic training ne evaluated relaxatin imagery and three evaluated varius cmbined methds. Nine trials used relaxatin as an active interventin fr depressin, whereas six used it as a cntrl r placeb cnditin fr cmparisn with sme active treatment. The relaxatin treatment was manualised fr 11 f the trials. The number f sessins f relaxatin treatment varied cnsiderably: 5-8 (1 trial), 6 (1 trial), 7 (3 trials), 10 (4 trials), 12 (1 trial), maximum f 20 (1 trial), 21 (1 trial) and 40 (1 trial). The treatment was delivered by therapeutically trained persns except in 3 trials where it was self-administered and ne where it was unclear. The trials varied in the interventins t which relaxatin was cmpared and sme cmpared it t mre than ne ther interventin. Six cmpared 2
it t wait-list, n treatment, r minimal interventin cntrls; ten t psychlgical treatment; fur cmpared it t lifestyle r cmplementary therapies (exercise, light therapy, massage); and tw t antidepressant medicatin. Participants were selected as depressed using a diagnstic apprach in three trials, a cutff n a depressin scale was used in seven trials, bth a diagnsis and scale cut-ff in fur trials and ne study did nt state a methd f selectin. The settings f the treatment were with in-patients, six were in educatinal settings, six were in cmmunity r hme settings, and ne was unclear abut setting. All but six f the trials were carried ut in the USA: these were frm Germany, Canada, Australia and the UK. In all f the trials, depressin was the primary diagnsis rather than secndary t a medical cnditin. Because f the varied measures f depressin used, it was difficult t describe the severity f the participants, apart frm nting that six trials required a diagnsis fr entry (Hwever, sme trials did use a diagnstic methd f participant selectin and these prduced similar effects t trials that selected participants using a symptm scale cutff). Peple with a anxiety disrder as primary diagnsis were excluded. Data n cmrbidity with anxiety symptms was nt prvided. GRADE Tables Table 1 Authr(s): Van Ommeren. Mark, Barbui, Crrad Date: 2009-05-26 Questin: Shuld relaxatin vs usual care be used fr depressive episde/disrder? Settings: Bibligraphy: Jrm AF, Mrgan AJ, Hetrick SE (2008). Relaxatin fr depressin. Cchrane Database f Systematic Reviews, (4):CD007142. Summary f findings Quality assessment N f studies Design Limitatins Incnsistency Indirectness Imprecisin Other cnsideratins N f patients relaxatin usual care Relative (95% CI) Effect Abslute Quality Imprtance depressin symptm level (pst interventin) (Better indicated by lwer values) 5 randmized trials limitatins 1 serius 2 indirectness serius 69 3 67 3 - SMD 0.59 lwer (0.94 t 0.24 lwer) 3,4,5 CRITICAL nn-respnse (pst interventin) 3
2 randmized trials limitatins incnsistency indirectness very serius 6 6/25 (24%) 7 25/27 RR 0.28 (0.14 t 667 fewer per 1000 (frm 426 (92.6%) 7 0.54) 7 fewer t 796 fewer) CRITICAL functining pst interventin (Better indicated by lwer values) 0 N evidence available 0 0 - MD 0 higher (0 t 0 higher) IMPORTANT depressin symptm level (+ 6 mnths fllw-up (fllw-up 6 mnths; Better indicated by lwer values) 1 randmized trials limitatins incnsistency Serius 8 very serius 6,9 11 10 11 10 - SMD 0.39 lwer (1.24 lwer t 0.45 higher) 10 VERY IMPORTANT nn-respnse / remissin (+ 6 mnths fllw-up 1 randmized trials limitatins incnsistency very serius 8,11 very serius 6 6/17 13/16 RR 0.43 (0.22 t 463 fewer per 1000 (frm 114 (35.3%) 12 (81.3%) 12 0.86) 12 fewer t 634 fewer) VERY IMPORTANT Drp uts 4 13 randmized trials limitatins serius 14 indirectness 15 very serius 16,17 4/61 6/61 RR 0.72 (0.08 t 28 fewer per 1000 (frm 90 (6.6%) 13 (9.8%) 13 6.73) 13 fewer t 564 mre) VERY IMPORTANT 1 There are few drp uts. Data are available in 4 f 5 studies with a ttal f 6 drp-uts f 60 participants (handcalculated based n data prvided in analysis 1.1 (p.54) and the descriptin f the individual studies in the appendix). 2 I squared is 49%. Frmally this wuld nt require dwngrade. Hwever, inspectin f frest plt als suggests sme degree f hetergeneity - s we dwngraded with 1 pint. 3 see analysis 1.1, Jrm et al (2008) p.54. 4 This is SMD fr self-reprted data. This Cchrane review suggested a much higher SMD (-1.35) fr very hetergenus (83%) clinician-rated data (pled data frm 2 studies) (see analysis 1.4, Jrm et al (2008) p.55). 5 Even thugh these data suggest mderate effectiveness fr relaxatin, this review fund even larger effect sizes fr (ther) psychlgical treatment (See fr example Analysis 2.1, N=9; n = 286; MSD = 0.38 [95% CI 0.14, 0.62]). The review als cmpared medicatin plus relaxatin with medicatin alne and fund a significant effects (see fr example Analysis 5.1, N =2, n =40: MSD = -0.90 (95% CI -1.56. -0.24). 6 Very small data set (less than 100 peple). 7 see analysis 1.6 Jrm et al (2008), p. 57. 8 Only 1 study, s n data in generalizability. 9 Number f participants fr the analyses is belw 50 (see analysis tables 1.3, 1.7, ), Jrm et al (2008)). 10 see analysis 1.3, Jrm et al (2008) p.55. 11 n 6 mnth fllw up data available. The nly study was Kahn (see analysis 1.7, Jrm et al (2008)). Fllw up was nly 1 mnth (see sentence n Kahn 1990 in first sentence f page 9 by Jrm et al (2008)). 12 see analysis 1.7. Jrm et al (2008), p.57. 13 See analysis 1.9, Jrm et al (2008), p.58. 4
14 I-squared is 53% in analysis tables 1.9, Jrm et al (2008), p.58. 15 Drp-uts are used as a prxy indicatr fr the utcme, which is cunted as direct evidence f the utcme. 16 Cnfidence interval includes bth n effect and appreciable benefit and harm. 17 Small data set (less than 200 peple). Reference List Jrm AF et al (2002) Effectiveness f cmplementary and self-help treatments fr depressin. Medical Jurnal f Australia, 176:S84 96. Jrm AF, Mrgan AJ, Hetrick SE (2008). Relaxatin fr depressin. Cchrane Database f Systematic Reviews, (4):CD007142. Pilkingtn K et al (2005). Yga fr depressin: the research evidence. Jurnal f Affective disrders, 89:13-24. Frm evidence t recmmendatin Factr Explanatin Narrative summary f the evidence base n the scped questin There is lw quality evidence favring relaxatin ver treatment as usual in reducing depressin symptms pst treatment (N = 5; n = 136; SMD = -0.59; 95% CI, -0.94 t -0.24) and in treatment respnse (N = 2; n = 52; RR [nnrespnse] = 0.28; 95% CI, 0.14 t 0.54). There is limited/very lw quality evidence favring relaxatin ver treatment as usual in reducing depressin symptms 6 mnths pst treatment (N = 1; n = 22; SMD = -0.39; 95% CI, -1.24 t -0.45) and in treatment respnse 6 mnths pst treatment (N = 1; n = 33; RR [nn-respnse] = 0.43 (95% CI 0.22 t 0.86). In terms f drp uts, the evidence is incnclusive and s it is nt pssible t determine if there is a clinically imprtant difference between relaxatin and treatment as usual (N = 4; n = 122; RR [nn-respnse] = 0.72 (95% CI 0.08 t 6.7). Summary f the quality f evidence See abve text n narrative summary Data n functining were typically nt included in the trials and were nt meta-analyzed 5
Additinal evidence (eg related evidence that was nt scped It shuld be nted that Jrm et al (2008) review fund (a) relaxatin less effective than ther psychlgical treatments and (b) that relaxatin plus medicatin was mre effective than medicatin alne (see ftnte 5 GRADE table). The Pilkingtn et al (2005) systematic review f yga fr depressin identified 5 randmized cntrlled trials, each f which utilised different frms f yga interventins and in which the severity f the cnditin ranged frm mild t severe. All trials reprted psitive findings but methdlgical details such as methd f randmisatin, cmpliance and attritin rates were missing. N adverse effects were reprted with the exceptin f fatigue and breathlessness in participants in ne study. Balance f benefits versus harms Define the values and preferences including any variability and human rights issues Althugh there are sme data n drp-uts, data n adverse effects were nt meta-analyzed. The balance f benefits versus harm seems favrable fr relaxatin if cmpared t treatment as usual but if the chice is with ther psychlgical treatment, than the benefits will be less. Indeed if the prvider decides t prvide relaxatin rather than mre effective treatment, then this wuld be - relatively speaking - harmful. The interventin is cnsistent with the value f prmtin f individual and family members capacity and skills Althugh Jrm et al (2008) review mainly fcused n studies f prgressive relaxatin, it is nted that many scieties have their wn culture-based frms f relaxatin, such as Yga, which has an evidence basis (Pilkingtn et al, 2005) Define the csts and resurce use and any ther relevant feasibility issues The administratin f relaxatin exercises is a relative nn-sphisticated interventin that can be quickly learned. The reviewed literature invlved evaluatin f relaxatin as a multiple sessin activity, with mst studies invlving: 5-10 sessins. Prgressive muscle relaxatin was the mst studied frm f translatin, this frm f relaxatin wuld take abut 20 minutes f time t administer. The feasibility f this interventin in nnspecialized health care settings depends n the time that the prvider has available as the interventin, as tested in the literature, tends t invlve 5-10 sessins f a 20 minutes interventin. In situatins where there is sufficient staff eg when cmmunity paraprfessinal health wrkers (e.g cmmunity health wrkers, midwives, health wrkers) are available. This interventin is likely t be feasible in nn-specialized health care settings Implementing these interventins may be dne in grup sessins (mre cst-effective) 6
Final recmmendatin Relaxatin training may be cnsidered as treatment f adults with depressive episde/disrder. In mderate and severe depressin, this interventin shuld be cnsidered as adjunct t antidepressants r structured brief psychlgical treatments. Strength f Recmmendatin: STANDARD Limitatins The cmparative effectiveness f relaxatin training versus ther psychlgical r pharmaclgical interventins was nt assessed. Update f the literature search June 2012 In June 2012 the literature search fr this scping questin was updated. The fllwing systematic review was fund t be relevant withut changing the recmmendatin: NICE Clinical Guidelines. CG90. Depressin in adults: The treatment and management f depressin in adults. Appendix 19: Clinical evidence frest plts. Natinal Institute fr Health and Clinical Excellence, 2010. 7