Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Study Overview
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Brief Summary
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The efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. The basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.

Detailed Description
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After thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. In the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95 persons are offered, after adequate information, to choose which of the two they prefer. Twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT; SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.

Official Title
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Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions

Conditions
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Panic Disorder (With or Without Agoraphobia)

Intervention / Treatment
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* Behavioral: Panic Control Treatment (PCT)
* Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
* Other: Waiting-list


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia Age between 18 and 60 Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up Ability to complete the active treatment phase (not including follow-ups) within 16 weeks Exclusion Criteria: Active substance dependence (6 months remission necessary) Current psychosis, delusions, mania, or active addiction Acute suicidality A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered Active involvement in a legal dispute related to their mental health issues Three or more unexcused absences

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized Panic Control Treatment<br>Patients who have been randomized to the randomization condition are assigned to PCT | Behavioral: Panic Control Treatment (PCT)<br>* Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.<br>|
| Experimental: Randomized Panic-Focused Psychodynamic Psychotherapy<br>Patients who have been randomized to the randomization condition are assigned to PFPP | Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)<br>* Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.<br>|
| Experimental: Self-selected Panic Control Treatment<br>Patients who have been randomized to the self-selection condition choose PCT | Behavioral: Panic Control Treatment (PCT)<br>* Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.<br>|
| Experimental: Self-selected Panic-Focussed Psychodynamic Psychotherapy<br>Patients who have been randomized to the self-selection condition choose PFPP | Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)<br>* Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.<br>|
| Experimental: Waiting-list<br>Patients who have been randomized to the waiting-list are offered sparse contact over telephone for 12 weeks and are then re-randomized to one of the other four arms | Other: Waiting-list<br>* Sparse telephone contact during 12 weeks, then re-randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997) |  | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination | 
| Change in occupational status |  | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination | 
| Change in absence from work due to sickness |  | Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985) |  | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination | 
| Change in health care utilization (number of medical contacts, and emergency visits, medication) |  | Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination | 
| Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000) |  | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination | 
| Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979) |  | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination |