Are psychological treatments of panic disorder efficacious?

Transcription

1 Are psychological treatments of panic disorder efficacious? Peter Wilhelm 7.3 and PD Dr. Peter Wilhelm, Spring

2 Efficacy of Behavioral Treatment of Panic Disorder First randomised controlled trial Barlow and colleagues Barlow, D. H., Craske, M. G., Cerny, J. A. & Klosko, J. S. (1989). Behavioral treatment of panic disorder. Behavior Therapy, 20, Craske, M. G., Brown, T. A. & Barlow, D. H. (1991). Behavioral treatment of panic disorder: A two-year follow-up. Behavior Therapy, 22, PD Dr. Peter Wilhelm, Spring

3 Efficacy of Behavioral Treatment of Panic Disorder Background: Panic Disorder, DSM 5 (p. 190) Individual experiences recurrent unexpected panic attacks, and is persistently concerned or worried about having more panic attacks, or changes his or her behavior in maladaptive ways because of the panic attacks (e.g., avoidance of exercise or of unfamiliar locations). Panic attacks are abrupt surges of intense fear or intense discomfort that reach a peak within minutes, accompanied by physical and/or cognitive symptoms: e.g. accelerated heart rate, sweating, trembling or shaking, shortness of breath, chest pain or discomfort.., fear of loosing control, fear of dying. 12 month prevalence: 2-3%, women vs men: 2:1 High comorbidity PD Dr. Peter Wilhelm, Spring

4 Efficacy of Behavioral Treatment of Panic Disorder Background State of the art treatment for panic disorder, in the1980s, when the study was conducted: Panic attacks can effectively be treated with psychoactive drugs (Benzodiazipines) Behavioral therapy is effective in treating avoidance behavior (via in vivo confrontation) Implicit assumption: Behavioral therapy is not an efficacious treatment for panic disorder without agoraphobic avoidance PD Dr. Peter Wilhelm, Spring

5 Efficacy of Behavioral Treatment of Panic Disorder Background Is cognitive behavioral therapy (CBT) efficacious for the treatment of panic disorder without agoraphobic avoidance? State of research Several case studies in which CBT led to an improvement (e.g. Gitlin et al., 1985; Clark, Salkovskis & Chalkley, 1985) 1 controlled pilot study (Biofeedback, PMR & cognitive Therapy vs. waiting list control group), with 11 patients (Barlow, Cohen et al., 1984) PD Dr. Peter Wilhelm, Spring

6 Efficacy of Behavioral Treatment of Panic Disorder Aim of the studie Objective: Evaluating the efficacy of a newly developed CBT for the treatment of panic disorder PD Dr. Peter Wilhelm, Spring

7 Efficacy of Behavioral Treatment of Panic Disorder Treatment conditions Exposition & cognitive Therapy (E&C) Cognitive restructuring: Acquiring skills for re-evaluating beliefs and appraisals about environmental and internal physiological cues analysis of faulty logic, reattribution, decatastrophizing, self instruction Interoceptive exposure after the 5 th session: Anxiety hierarchy. Cognitive skills were applied to anxiety provocing situations through visualisation of anxiety scences and overbreathing. Progressive Muscle Relaxation (R) 2x exercises per day. After 5th session: exercising the use of relaxation as a coping skill Relaxation combined with exposition und cognitive therapy (Comb) Wait list control group PD Dr. Peter Wilhelm, Spring

8 Efficacy of Behavioral Treatment of Panic Disorder Application of treatments Single Therapy: 1 x per week, 15 weeks Treatment manuals: detailed description for evry session Therapist: 10 doctoral students and psychologists, who were trained for all interventions Weekly supervision Treatment Integrity All sessions were audiotaped 35 tapes were randomly selected: Two 5 min segments were selected and therapist behavior was rated Patients rated credibility and Logic of treatment (after 1. and last session, follow up) PD Dr. Peter Wilhelm, Spring

9 Efficacy of Behavioral Treatment of Panic Disorder Participants Patients of Phobia and Anxiety Disorder Clinic, State University of New York Panic Disorder without or only slight Agoraphobia PD Dr. Peter Wilhelm, Spring

10 Efficacy of Behavioral Treatment of Panic Disorder Sample: Inclusion and exclusion criteria Inclusion Criteria DSM III-R: Panic disorder, no or slight agoraphobic avoidance Therapist Rating: Severity of disorder > 4 (Scale 0 to 8) (Anxiety Disorder Interview Schedule-Revised; ADIS-R) At least 1 attack within the last 2 weeks (diary, 4 times daily) Patients who already got other treatments not related to anxiety Stable medication Exclusion Criteria Age 18 to 65; Alcohol- or substance abuse Major depression, psychosis, organic brain syndrome Other therapies of anxiety / Begin of Psychopharmacological treatment less than 3 Mon. benzodiazepines, less than 6 Mon. MAO-Hemmer, tricyclic antidepressants) PD Dr. Peter Wilhelm, Spring

11 Efficacy of Behavioral Treatment of Panic Disorder Meassurements Standardized Interviews (blind judges) Hamilton Anxiety and Depression Scales Standardized Self-Reports State-Trait Anxiety Inventory (Spielberger, Gorusch, & Lushene, 1970) Cognitive Somatic Anxiety Questionnaire, (Marks & Mathews, 1979), Fear Questionnaire (Marks & Mathews, 1979) Beck Depression Inventory (Beck et al., 1961) Psychosomatic Rating Scale (Cox, Freundlich & Meyer, 1975) Subjective Symptom Scale (Modification, Hafner & Marks, 1978) Self-Observation: Structured diary (4 times daily) Anxiety Rating from 0 to 8; Panic yes/no; stressful events? PD Dr. Peter Wilhelm, Spring

12 Efficacy of Behavioral Treatment of Panic Disorder Composite measures of clinically significant change Treatment responder 20% Improvement in three of four measures: Clinical rating of severity (> 2 points) Fear Questionnaire (> 2 points) Number of panic attacks per week Subjective Symptom Scale Total score (> 8 points) Treatment non-responder Deterioration of 20% (Pre-Post) in any of the measures (independent of improvement in other variables) End state functioning absolute level of functioning at Post-Assessment(only completers) low end state (LES) vs high end state (HES) PD Dr. Peter Wilhelm, Spring

13 Efficacy of Behavioral Treatment of Panic Disorder Research Design Patients were randomly assigned to 4 conditions Assessment : Pre Post Follow up: 3, 6, 12, 24 months PD Dr. Peter Wilhelm, Spring

14 Efficacy of Behavioral Treatment of Panic Disorder Sample size and drop-outs (in %) Pre Post 6-Month 24-Month Wait-list (6%) - - Exposition (E) & Cognitive Therapie (C) (6%) 8 15 Relaxation (R) (33%*) 9 9 Combined (E & C & R) (17%) 6 10 Comparison drop-outs vs. completers (ANOVAS) Drop-outs: lower severity at pre treatment Higher consumption of anxiolytics * signifikant PD Dr. Peter Wilhelm, Spring

15 Efficacy of Behavioral Treatment of Panic Disorder Change in sample size over time PD Dr. Peter Wilhelm, Spring

16 Efficacy of Behavioral Treatment of Panic Disorder Treatment Responders at Post-Assessment N = 54; lacking information for n = 13 significant PD Dr. Peter Wilhelm, Spring

17 Efficacy of Behavioral Treatment of Panic Disorder High End-State Functioning at Post-assessment N = 53; lacking information for n = 14 significant PD Dr. Peter Wilhelm, Spring

18 Efficacy of Behavioral Treatment of Panic Disorder Comparison: Pre-Post Assessment Reduction in clinical rating of severity All treatment groups significantly improved but not CG All treatment groups were significantly better than CG Reduction in Hamilton Anxiety Score All treatment groups significantly improved but not CG R and Combined G were significantly better than control group Psychosomatic Symptoms Only relaxation group significantly improved Only R was significantly better than CG No significant differences in the other measures PD Dr. Peter Wilhelm, Spring

19 Efficacy of Behavioral Treatment of Panic Disorder Patients without panic attacks. Post-Assessment (Study completers) PD Dr. Peter Wilhelm, Spring

20 Efficacy of Behavioral Treatment of Panic Disorder Patients without panic attacks. Post-Assessment (Intent to treat analysis with total sample) PD Dr. Peter Wilhelm, Spring

21 Efficacy of Behavioral Treatment of Panic Disorder 24 Month Follow-Up: Summary Maintainance of therapy success Decrease of trait-anxiety and somatic symptoms (Post vs. 24 months) BDI-Scores Increase in R-group Decrease in E & C-group PD Dr. Peter Wilhelm, Spring

22 Efficacy of Behavioral Treatment of Panic Disorder Participants with high end state and without panic (Excluding drop outs) PD Dr. Peter Wilhelm, Spring

23 Efficacy of Behavioral Treatment of Panic Disorder Participants with high end state and without panic (Including drop outs) significant for Panic-Free PD Dr. Peter Wilhelm, Spring

24 Efficacy of Behavioral Treatment of Panic Disorder 24 months Follow-Up: Other Psychological Treatments Alternative Psychotherapy: R 83%, E&C 33%, COMB 40% Psychopharmaca R 71%, E&C 17%, COMB 43% PD Dr. Peter Wilhelm, Spring

25 Efficacy of Behavioral Treatment of Panic Disorder Summary of results Post Assessment: (R, E&C, E&C&R) > Wait list In relaxation group, less patients were panic free, However anxiety and psychosomatic symptoms were reduced. Follow up: Maintenance of therapy success over 2 years For patients with interoceptive exposer and cognitive restructuring Patients in relaxation group less stable patterns Highest drop out rate Highest rate of additional treatment Cognitive behavioral therapy with relaxation (E&C&R) was not more efficacious than E&C PD Dr. Peter Wilhelm, Spring

26 Efficacy of Behavioral Treatment of Panic Disorder Conclusions Panic disorder without agoraphobic avoidance can be efficaciously treated with a combination of interoceptive exposer + cognitive restructuring Directly after treatment, relaxation is as efficacious as interoceptive exposer + cognitive restructuring, but in the long run it is less efficacious. Relaxation is not a necessary component of an efficacious treatment of panic disorder. Interoceptive exposer + cognitive restructuring is sufficient. Compared to results in the literature, long term effects of interoceptive exposer and cognitive restructuring seem to better than pharmacological treatment PD Dr. Peter Wilhelm, Spring

27 Cognitive-behavioral therapy, pharmacotherapy, or their combination for treating panic disorder (PD): A randomized controlled trial (RCT) (Barlow, Gorman, Shear, & Woods, 2000) Barlow, D. H., Gorman, J. M., Shear, M. K., & Woods, S. W. (2000). Cognitive behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. Journal of the American Medical Association, 283, PD Dr. Peter Wilhelm, Spring

28 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Background Background: Well established efficacy for two PD treatments Psychological treatment: CBT Pharmacological treatment with Imipramine (Tofranil) First tricyclic antidepressant, discovered 1951 by Ciba Geigy (today Novartis) increases the extracellular level of neurotransmitters (serotonin, norepinephrine ) by limiting their reabsorption (reuptake) into the presynaptic cells Broad range of effects Improves mood, reduces symptoms of agitation and anxiety side effects: dry mouth, drowsiness, dizziness, blurred vision, low blood pressure, rapid heart rate, increased sweating, diarrhea, stomach cramps, increase of appetite, weight gain PD Dr. Peter Wilhelm, Spring

29 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Objectives Relative and combined efficacies of drug and PT treatment for PD have not been evaluated Objectives: To evaluate, whether drug and PT for PD are each more efficacious than placebo one treatment is more efficacious than the other combined therapy is more efficacious than either therapy alone? PD Dr. Peter Wilhelm, Spring

30 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Study design 312 panic disorder patients were randomly assigned to five groups (double blind) CBT Imipramine Drug placebo CBT + Imipramine CBT + Drug placebo PD Dr. Peter Wilhelm, Spring

31 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Treatments (acute phase) Treatments were manualized for each condition Acute treatment phase: 11 sessions during 12 weeks for each condition CBT individual 50-minute sessions Interoceptive exposure, cognitive restructuring, and breathing training Psychopharmacotherapy (Imipramine or Placebo) + Clinical Management individual 30-minute contacts monitor adverse effects, clinical state, and physical/mental condition maximize compliance proscribe specific interventions included in CBT (cognitive restructuring of anxiety and panic symptoms) Imipramine treatment was slowly titrated up to a maximum of 300 mg/day Blood levels were assessed at 6 and 12 weeks Combined Treatment (Imipramine or Placebo + CBT) individual contacts with 2 therapists for about 75 minutes per week. Benzodiazepine screening of urine samples PD Dr. Peter Wilhelm, Spring

32 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Treatments (maintenance phase) Responders to acute treatment entered a 6-month maintenance phase without breaking the study blind. 6 monthly appointments in which treatment similar to the acute treatment was continued After maintenance phase treatment was stopped PD Dr. Peter Wilhelm, Spring

33 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Therapists Therapists providing CBT were doctoral level clinicians who underwent extensive training Pharmacotherapists were experienced psychiatrists who underwent additional training Ongoing supervision, biweekly Adherence and competence ratings were collected after listening to a sample of audiotaped sessions PD Dr. Peter Wilhelm, Spring

34 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Assessment at baseline after acute phase (3 months after baseline) after maintenance phase (9 months after baseline) after follow-up phase (15 months after baseline) Trained evaluators (blind to treatment assignment) judged patients on Panic Disorder Severity Scale (PDSS) clinician-rated scale of PD severity Response was defined > 40% reduction of PD symptoms Clinical Global Impression Scale (CGI), 7-point ratings on 2 items: overall improvement and severity Definition of responders: CGI much improved ( 2) while being rated as mild or less ( 3) on CGI severity Patients who received nonstudy treatment for anxiety = nonresponders PD Dr. Peter Wilhelm, Spring

35 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Patients Inclusion criteria: Potential participants met DSM-III-R or DSM-IV criteria for PD with no more than mild agoraphobia (ADIS-R avoidance scale 18) Panic attack(s) in the 2 weeks before treatment Patients with comorbid unipolar depression were not excluded Patients were permitted to take benzodiazepines until end of acute phase Exclusion criteria psychotic, bipolar, or significant medical illnesses, suicidality, significant substance abuse, contraindications to either treatment, prior nonresponse to similar treatments, concurrent competing treatment or pending disability claims PD Dr. Peter Wilhelm, Spring

36 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Allocation of Patients PD Dr. Peter Wilhelm, Spring

37 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Drop outs during acute phase PD Dr. Peter Wilhelm, Spring

38 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (Intent to treat, N = 312) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

39 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (intent to treat) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * * Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

40 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (Intent to treat, N = 312) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * * n.s. Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

41 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (Intent to treat, N = 312) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * n.s. * n.s. Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

42 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (Intent to treat, N = 312) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * n.s. n.s. * n.s. Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

43 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (Intent to treat, N = 312) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators * n.s. n.s. n.s. * n.s. Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

44 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of acute phase (3 months) (completers N = 213) * n.s. # # n.s. n.s. Placebo CBT Imipramine CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

45 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders in maintenance phase and follow up Only Responders entered maintenance phase PD Dr. Peter Wilhelm, Spring

46 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of 6-month maintenance phase (Intention to continue maintenance N = 170) * n.s. # # n.s. n.s. Placebo CBT Imipramine CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

47 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of 6-month maintenance phase (Intent to treat, N = 312) After 6-month maintenance phase: responders continued medication or monthly CBT * * * * Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

48 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders in maintenance phase and follow up Only Responders entered maintenance phase Maintenance responders were assessed at follow up; except 17, who were randomly selected for a pilot study. PD Dr. Peter Wilhelm, Spring

49 Percent CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at the end of 6-month follow up phase (Intention to continue follow up: N = 116) n.s. n.s n.s. # ** * Placebo CBT Imipramine CBT + Placebo CBT + Imipramine PD Dr. Peter Wilhelm, Spring

50 Percent 100 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Responders (%) at follow up 6 months after maintenance (Intent to treat, N = 295; 17 were randomly excluded after maintenance phase) After 6-month follow up without treatment * # Placebo CBT Imipramine IPT CBT + Placebo CBT + Imipramine # PD Dr. Peter Wilhelm, Spring

51 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Summary and conclusions of the authors Both imipramine and CBT are better than pill placebo for treatment of PD (post acute, post maintenance) High attrition in placebo group; weak and non durable response Imipramine produced a superior quality of response until end of maintenance CBT had more durability and was somewhat better tolerated Relapse 4% for CBT, 25% for Imipramine Coadministration of Imipramine and CBT resulted in limited benefit over monotherapy Improvement after maintenance addition of imipramine appeared to reduce long-term durability of CBT Potential underestimation of benefits of medication by using a tricyclic antidepressant instead of an SSRI PD Dr. Peter Wilhelm, Spring

52 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) What are limitations and problems of this study? PD Dr. Peter Wilhelm, Spring

53 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) What are limitations and problems of this study? Design is in favor of pharmacotherapy Pharmacotherapy = drug (placebo) + clinical management Assessment Imipramine and Placebo condition: Every week 30-minute contact with psychiatrist; recommendations and prescription of exposure (not typical for usual psychiatric drug treatment) Combined treatment (Imipramine or Placebo + CBT), individual contacts with 2 therapists for about 75 minutes per week (higher dosage of treatment than CBT alone) only based on external interviewer ratings of current symptoms and improvement. Patients perspective was not assessed, which shows usually less difference to placebo No adverse effects of treatment were assessed (side effects) Pharmacotherapists were experienced psychiatrists; CBT therapists were doctoral level clinicians, prior experience was not required Placebo effect was probably underestimated Blinding did probably not work for many patients because placebo did neither produce positive effects nor side effects Blinding did probably not work for doctors -> lower positive expectations High and selective drop out rates impair interpretation of results Drop outs in placebo group: post = 58%, maintenance and follow up = 88% Drop outs imipramine: post = 39%, maintenance = 52%, follow up = 68% Drop outs CBT: post = 27%, maintenance = 47%, follow up = 62% -> underestimation of placebo effect in ITT analyses PD Dr. Peter Wilhelm, Spring

54 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) What are limitations and problems of this study? Selected patients who accept drug treatment Many patients who were eligible refused participation in the study unwilling to start treatment with imipramine (30.6% and 47.4%), or discontinue their current medication (22.6% and 35.1%). Results from comparative treatment outcome studies are limited not only to people who meet the study criteria but also to those who are willing to begin a medication treatment and discontinue their current medication. (Hofmann et al., 1998, p. 43) PD Dr. Peter Wilhelm, Spring

55 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) What are limitations and problems of this study? Design is in favor of pharmacotherapy Pharmacotherapy = drug (placebo) + clinical management Imipramine and Placebo condition: Every week 30-minute contact with psychiatrist; recommendations and prescription of exposure Combined treatment (Imipramine or Placebo + CBT), individual contacts with 2 therapists for about 75 minutes per week (higher dosage of treatment than CBT alone) Blinding did probably not work for many patients because Placebo did neither produce positive effects nor side effects Blinding did probably not work for doctors Assessment is only based on external interviewer ratings of current symptoms and improvement. Patients perspective was not assessed No adverse effects of treatment were assessed (side effects) PD Dr. Peter Wilhelm, Spring

56 CBT, pharmacotherapy, or their combination? (Barlow et al., 2000) Conclusion drawn from the Barlow et al. (2000) study (APA practice guidelines, 2009, p. 52) This study provided evidence for the short- and long-term efficacy of CBT CBT is largely equivalent in short-term efficacy to imipramine and combination treatments, CBT may produce more durable effects than imipramine or the combination of CBT and imipramine PD Dr. Peter Wilhelm, Spring

57 Conclusions about efficacy of CBT treatments for panic disorder (APA practice guidelines, 2009, p. 51) There are numerous controlled trials demonstrating the efficacy of CBT for panic disorder Meta-analyses of clinical trials support the conclusion that effects of CBT for panic disorder are robust and durable. PD Dr. Peter Wilhelm, Spring

58 Take home message With an RCT Barlow & colleagues (1989) could show that Relaxation is not a necessary component for treating panic disorder, relaxation is sufficient Cognitive restructuring and interoceptive exposer is an efficacious treatment for panic disorder and an alternative to pharmacotherapy With another RCT Barlow et al. (2000) could show that CBT is as efficacious as Imipramine for the treatment of panic disorder directly after treatment After treatment has been stopped CBT is more efficacious than imipramine. CBT is recommended as a first line treatment for panic disorder in national guidelines: American Psychiatric Association (APA) (2009). National Institute for Health and Care Excellence (NICE) (2011, 2015). Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.v. (AWMF) Compare guidelines with critical Cochrane review (Imai, Tajika, Chen, Pompoli, & Furukawa, 2016). PD Dr. Peter Wilhelm, Spring

59 Take home message: Methodological issues Drop outs are a common problem in therapy outcome studies Intent to treat analysis (ITT) (e.g. last value carried forward) is a method to deal with drop outs ITT might change the pattern of results suggested by completer analyses When drop out rates are different for different conditions, ITT may lead to biased results Long term follow up assessments are essential to demonstrate the sustainability of treatment effects There might be problems with the generalization of results Treatments are not applied as in clinical practice Patients are highly selected PD Dr. Peter Wilhelm, Spring

60 References American Psychiatric Association (2009). Practice guideline for the treatment of patients With panic disorder (2nd ed.). American Psychiatric Association. Retrieved from American Psychiatric Association [APA] (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: American Psychiatric Association. Bandelow, B., Wiltink, J., Alpers, G. W., Benecke, C., Deckert, J., Eckhardt-Henn, A.,... Beutel, M. E. (2014). Deutsche S3- Leitlinie Behandlung von Angststörungen. Retrieved from Barlow, D. H., Craske, M. G., Cerny, J. A. & Klosko, J. S. (1989). Behavioral treatment of panic disorder. Behavior Therapy, 20, Barlow, D. H., Gorman, J. M., Shear, M. K., & Woods, S. W. (2000). Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. Journal of the American Medical Association, 283, Craske, M. G., Brown, T. A. & Barlow, D. H. (1991). Behavioral treatment of panic disorder: A two-year follow-up. Behavior Therapy, 22, Hofmann, S. G., Barlow, D. H., Papp, L. A., Detweiler, M. F., Ray, S. E., Shear, M. K.,... Gorman, J. K. (1998). Pretreatment attrition in a comparative treatment outcome study on panic disorder. American Journal of Psychiatry, 155 (1), Imai, H., Tajika, A., Chen, P., Pompoli, A., & Furukawa T. A. (2016). Psychological therapies versus pharmacological interventions for panic disorder with or without agoraphobia in adults. Cochrane Database of Systematic Reviews, 10, Art. No.: CD DOI: / CD pub2. National Institute for Health and Care Excellence [NICE] (2011). Generalised anxiety disorder and panic disorder in adults: management. Clinical guideline. Retrieved from National Institute for Health and Care Excellence [NICE] (2015). Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults: Management in primary, secondary and community care. Recommendation for Guidance Executive. Retrieved from PD Dr. Peter Wilhelm, Spring

61 Links to Practice Guidelines United States American Psychiatric Association (APA) United Kingdom National Institute for Health and Care Excellence (NICE) Germany Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.v. (AWMF) Cochrane Society Global independent network of researchers, professionals, patients, carers, and people interested in health Cochrane contributors - 37,000 from more than 130 countries - work together to produce credible, accessible health information that is free from ccommercial sponsorship and other conflicts of interest. Retrieved from PD Dr. Peter Wilhelm, Spring