Evaluation of Psychological Interventions The importance of control groups Are psychological treatments of panic disorder efficacious? Peter Wilhelm 2.3.2016

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Overview of Today’s Lecture Control groups matter  When don’t we need a control group?  The first clinical trial: A historical example  What kind of control groups can we use?  The first randomized controlled trial to evaluate the efficacy of behavioral treatment of panic disorder

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

When don’t we need a control group? • When the treatment effect operates against our common knowledge and is dramatic • E.g. effect of jumping out of a plane without parachute (based on common knowledge) vs. with a parachute



The experiment of José Delgado “Matador’ With a Radio Stops Wired Bull” (NYT, 1965)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

When don’t we need a control group? The experiment of José Delgado Delgado had implanted a stimoceiver in the caudate nucleus of a bull. The next day Delgado stepped into the ring and challenged the bull like a matador and the bull attacked him.

Delgado stopped the animal mid-way by using a remote control to send an electric impulse into the bulls brain. “The experiment […], was probably the most spectacular demonstration ever performed of the deliberate modification of animal behavior through external control of the brain.” New York Times, May 17, 1965, p. 1, 20 ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial The problem: Scurvy Scurvy was the number one cause of mortality for sailors until the 19th century. By far more sailors died from scurvy, than from battles, or storms. Between 1500 and 1800 scurvy killed at least two million sailors. Symptoms of Scurvy • “Their gums were rotten even to the very roots of their very teeth, and their cheeks hard and swollen, • the teeth were loose neere ready to fall out ... • their breath a filthy savour. • The legs were feeble and so weak, that they were full of aches and paines, with many blewish and reddish staines or spots, some broad and some small like flea-biting.”

(William Clowes, who had served as a surgeon in Queen Elizabeth's fleet; Edzard & Singh, 2009, p. 14). ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial Treatments for scurvy until the end of 18th century Physicians proposed the following remedies:  bloodletting  mercury paste  salt water  vinegar  sulphuric acid, hydrochloric acid,  Moselle wine 

burying the patient up to his neck in sand



hard labour • doctors observed that scurvy was generally associated with lazyness. However, it was scurvy that caused sailors to be lazy, rather than laziness that made sailors vulnerable to scurvy.

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial The desperate situation and the turning point “Learned men around the world would fabricate arcane theories about the causes of scurvy and debate the merits of various cures, but nobody seemed capable of stopping the rot that was killing hundreds of thousands of sailors.” (Edzard & Singh, 2009, p. 16) 1747, came a major breakthrough. Naval surgeon James Lind (1716-1794) began his service on board of the HMS Salisbury. After traveling several months, several sailors had scurvy, and Lind did something completely new and unusual. “His sharp brain and meticulous mind allowed him to discard fashion, prejudice, anecdote and hearsay, and instead he tackled the curse of scurvy with extreme logic and rationality.” (Edzard & Singh, 2009, p. 16)

His idea was to systematically observe what would happen if he treated the ill sailors in different ways? ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial: Patients Lind identified 12 sailors  with similarly serious symptoms of scurvy.  their hammocks were placed in the same portion of the ship  all received the same breakfast, lunch and dinner • biscuits, salted meat, dried fish

Lind was helping to guarantee a fair test, because all patients were  similarly sick,  similarly housed  similarly fed

Thus, Lind held potential confounding variables constant. ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial: Treatments He divided the sailors into six pairs and gave each pair a different treatment:  a quart of cider,  twenty-five drops of vitriol (sulphuric acid) three times a day,  two spoonfuls of vinegar three times a day,  half a pint of sea water a day,  medicinal paste consisting of garlic, mustard, radish root and gum myrrh,  two oranges and a lemon each day.  In addtion, sailors who were ill and got the normal ship diet were observed (control group)). ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial: Results After 6 days:  sailors who were consuming lemons and oranges were almost completely recovered  all other patients were still suffering from scurvy  except for the cider drinkers who slightly improved

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The world’s first controlled clinical trial: Conclusion Although the numbers of patients were extremely small, the results were striking: oranges and lemons were the key to curing scurvy. (effects were huge). Lind had no idea, why oranges and lemons were so effective. However this was not important.  Demonstrating that a treatment is effective is the priority.  Understanding the exact details of the underlying mechanism can be left as a problem for subsequent research



Lind published his results 6 years later in a book which did not have an immediate impact.



1780 the physician Gilbert Blane read Lind’s book and replicated the trial, with many sailors. Later he became responsible for determining naval medical procedures. On 5 March 1795 the Board and the Admiralty agreed that sailors' were issued a daily ration of lemon juice.



​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Why oranges and limes cure scurvy? The discovery of the causal mechanism     



1927 Hungarian biochemist Albert Szent-Györgyi (1893-1986) isolated a compound he called hexuronic acid, 1932, The American biochemist Charles Glen King (1896-1988) isolated the same compound from lemon juice and demonstrated the connection between hexuronic acid and scurvy in guinea pigs. The acid was renamed: ascorbic acid; Vitamin C Vitamins are organic nutrients that cannot be produced by the body and have to be supplied through food. Vitamin C is used to produce collagen, which glues together the body's muscles, blood vessels and other structures, and so helps to repair cuts and bruises. A lack of vitamin C results in bleeding and the decay of cartilage, ligaments, tendons, bone, skin, gums and teeth. A scurvy patient disintegrates gradually and dies painfully. Studies on humans were conducted during WW II with conscientious objectors in the U.K. and in the 1960s with prisoners in the U.S • •



Symptoms of scurvy could be induced by an experimental scorbutic diet with extremely low vitamin C content. Symptoms could be completely reversed by additional vitamin C supplementation of only 10 mg per day.

100 g lemons or oranges contain about 53 mg Vitamin C.

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

What can we learn from this example? If you want to know whether a treatment is efficacious :  Compare groups of persons who get different treatments and no treatment to figure out which treatment works better than no treatment  Make sure that the groups are equal (comparable) before the treatment starts  Hold conditions in the groups constant except for the treatment condition you want to investigate -> Realize a randomized controlled trial (RCT)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

What can we learn from this example?  

Effects have to be replicated before further conclusions can be drawn It takes time to implement new discoveries into clinical practice



Efficacy research aims providing evidence that a treatment really works • It aims to provide technological knowledge

 

Efficacy research does (usually) not tell you why a treatment works If a treatment is efficacious, it can be beneficially used without having any idea or even a wrong idea why it works

 

Discovering the causal pathway is usually the goal of fundamental research Knowing the causal pathway will help to optimize treatment and develop an efficacious prevention • E.g. dropping unnecessary components • Adding components that facilitate or enhance the effects

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Why do we need an appropriate control group? to rule out alternative explanations (threats to internal validity) as good as possible : Cook & Campbell, 1979):

1.

Maturation • Spontaneous remission • Cyclic course of disease (Major Depression)

2.

History and external factors: • Patients get additional treatment (e.g. medication) • external factors (e.g. economic crisis, terrorism etc..)

3.

Mortality: • Patients, who do not profit, break up earlier

4. 5.

Regression to the mean Testing

6.

Instrumentation

• E.g. Reactivity of pre measurement • E.g. Bias of diagnostician Cook, T. D. & Campbell, D. T. (1979). Quasi -Experimentation. Design and analysis issues for field settings. Chicago: Rand McNally College Publishing Company.

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Possible control groups •

Control group without any treatment •

•

Wait-list control group • •

•

Participants get medication, without knowing whether it contains an active substance or not

„Psychotherapy placebo“ • •

•

Participants participate in the assessment Participants expect to receive treatment after a certain period of time

Pill-placebo •

•

Participants only participate in the assessment, but they do not expect treatment

credible treatment for the participant but no specific effect (e. g. discussion group, relaxation, reading disorder related books, self help manuals etc.)

Adding or Subtracting components of a treatment (dismantled comparison) •

Treatment with or without specific elements: e.g. CBT with relaxation, vs. CBT without relaxation, vs relaxation.

•

Treatment as usual (TAU)

•

Well established, evidence based treatments PT or medication

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Problems with untreated control groups • • • • •

Demoralization Patients drop out Patients seek other treatments Problem, if patients run into crisis Ethical problems: How can we justify to withholding a patient being efficaciously treated? • Depends on condition (e.g. depression vs. social phobia)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

The Placebo Concept does not Work for Psychotherapy Pharmacologic Placebo (sham medication)

„Psychotherapy Placebo“ (minimal treatment)

•

•

• • •

identical appearance of pharmacol. substance and placebo only difference = pharmacol. effect separation of substance and procedure of giving the substance expectancy effect controlled (double blind)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

• •

•

Substantial difference between Intervention and placebo -> credibility? Both have an influence on experience and behavior Technique and procedure can‘t be separated Therapist knows that placebo treatment is supposed to be less efficacious Expectancy effects

Problems with Psychotherapy Placebos • PT-Placebo without effect is not possible • Treatment needs to be plausible for patients and therapists • Assessment of treatment credebility

• Contains unspecific components: contact with therapist, appreciation, expectation of improvement, optimism • Ethical problem: • Patients do not get more effective treatment • Patients need to be informed and willing to obtain a psychotherapy placebo

• PT-Placebo = Control condition with low treatment • The more similar placebo and treatment the smaller the difference

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Problems with treatment as usual (TAU) (Westen et al., 2004) Quality of TAU often low: • Low budget • Low frequency of sessions • Often badly trained therapists • Therapists often have high work load

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

What does a particular control group control? Untreated Wait-list

Passage of time Expectation that there will be a treatment and improvement soon Having contact with doctor / therapist Receiving treatment

X

X

PillPlacebo

« Therapy Placebo» Minimal Treatment

Treatment as usual (TAU)

Evidence Based Treatment

X

X

X

X

X

X

X

X

X

X

X

X

(X)

(X)

X

X

(X)

(X)

X

X

(X)

X

X

Expectation that treatment will help Common factors: attention, warmth, appreciation, empathy, information … Specific effect of treatment

(X) Depends on the realization of the condition and / or participants’ expectations and believes ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Requirements for drawing valid conclusions from comparisons with control groups •

Participants in the treatment and control group need to be similar before treatment starts

•

Methods to ensure equality: • Participants will be randomly assigned to treatment conditions • works with large samples

• Randomized blocks assignment • Matching participants in subgroups that are comparable on key dimensions (baseline severity of disorder) • Members of group will then be randomly assigned to treatment condition

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Problems despite randomized control groups (Westen et al., 2004) •

•

Randomization does not work well with small samples (n > 40 per group) Participants drop out (Mortality) • Differences between participants who drop out and participants who complete the study • Different drop out rates in different groups • E.g. drop out rate higher in wait-list control group than in treatment group

Westen, D., Novotny, C. M. & Thompson-Brenner, H. (2004). The empirical status of empirically supported psychotherapies: Assumptions, findings, and reporting in controlled clinical trials. Psychological-Bulletin, 130, 631663.

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder A 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, 261-282. Craske, M. G., Brown, T. A. & Barlow, D. H. (1991). Behavioral treatment of panic disorder: A two-year follow-up. Behavior Therapy, 22, 289-304. ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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 (Benzodiazipine)  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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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 (z.B. 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)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Aim of the studie Evaluating the efficacy of a newly developed CBT for the treatment of panic disorder

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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 5th 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 ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Participants Patients of „Phobia and Anxiety Disorder Clinic“, State University of New York with

Panic Disorder and slight without or only slight Agoraphobia

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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?

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Sample size and drop-outs (in %) Pre

Post

6-Month

24-Month

Wait-list

16

15 (6%)

-

-

Exposition (E) & Cognitive Therapie (C)

16

15 (6%)

8

15

Relaxation (R)

15

10 (33%*)

9

9

Combined (E & C & R)

20

16 (17%)

6

10

Comparison drop-outs vs. completers (ANOVAS) Drop-outs: lower severity at pre treatment Higher consumption of anxiolytics * signifikant

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Change in sample size over time

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

„Treatment Responders“ at Post-Assessment

significant

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

„High End-State Functioning“ at Post-assessment

significant

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Patients without panic attacks. Post-Assessment (Study completers)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Patients without panic attacks. Post-Assessment (Intent to Treat analysis with total sample)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Participants with high end state and without panic (Study completers)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Efficacy of Behavioral Treatment of Panic Disorder

Participants with high end state and without panic (Total Sample)

significant for „Panic-Free“

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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%

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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 are better than pharmacological treatment

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

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 are better than pharmacological treatment

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Largest controlled efficacy trial of CBT for panic disorder (Barlow et al., 2000) 312 panic disorder patients were randomly assigned to five groups     

imipramine CBT CBT and imipramine CBT and placebo placebo



CBT consisted of 11 individual 50-minute sessions over 12 weeks.

  

Psychopharmacotherapy + Clinical Management double blind imipramine treatment was slowly titrated up to a maximum of 300 mg/day.

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, 2529–2536. ​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Largest controlled efficacy trial of CBT for panic disorder

Results at the end of treatment (intent to treat) Response was defined > 40% reduction in symptoms on Panic Disorder Severity Scale (PDSS) rated by trained evaluators 100

*

90 80

*

70 60 50 40

Percent

30 20 10 0 Placebo

CBT

IPT

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

CBT + Placebo

CBT + Imipramine

Largest controlled efficacy trial of CBT for panic disorder

Results at the end of 6-month maintenance phase Panic Disorder Severity Scale (intent to treat) 6-month maintenance phase: responders were continued on their medication or on monthly CBT * 100 90 80

*

*

70 60

*

50 40

Percent

30

20 10 0

Placebo

CBT

IPT

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

CBT + Placebo

CBT + Imipramine

Largest controlled efficacy trial of CBT for panic disorder

Results at follow up 6 months after maintenance Panic Disorder Severity Scale (intent to treat)

100 90 80

#

70

#

60 50

*

40

Percent

30 20 10 0 Placebo

CBT

IPT

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

CBT + Placebo

CBT + Imipramine

Largest controlled efficacy trial of CBT for panic disorder

Conclusion drawn from the Barlow et al. (2000) study by the 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

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Conclusions about efficacy of CBT treatments for panic disorder (2009, p. 51) 

There are numerous controlled trials demonstrating the efficacy of CBT for panic disorder

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Meta-analyses of clinical trials have concluded the effects of CBT for panic disorder are robust and durable.

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016

Take home message 

To demonstrate that a treatment is efficacious we need to apply an experimental control group design that can effectively rule out alternative explanations

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Randomized Controlled Trials (RCT) are the gold standard to determine efficacy

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The size of treatment effect depends on the control (comparison) group

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With an RCT Barlow & colleagues could show that cognitive restructuring and interoceptive exposer is an efficacious and alternative treatment to pharmacotherapy for panic disorder

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In later studies (e.g. Barlow et al., 2000) the efficacy of CBT for treatment of panic disorder could further be established

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CBT is recommended as a first line treatment for panic disorder in national guidelines (APA, NICE, AWMF)

​UNIVERSITY FRIBOURG, CH| Department of Psychology | Chair of Clinical Psychology and Psychotherapy| PD Dr. Peter Wilhelm, Spring 2016