Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Panic Disorder (With or Without Agoraphobia)
- Sponsor
- Region Skane
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in occupational status
Time Frame: 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
Time Frame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
Secondary Outcomes
- 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)