Clinical Trial: Psychotherapy Outcome and Self-selection Effects in Panic Disorder
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
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 Summary: 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.
Sponsor: Region Skane
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ]
Original Secondary Outcome: Same as current
Information By: Region Skane
Dates:
Date Received: March 19, 2012
Date Started: January 2010
Date Completion: June 2017
Last Updated: September 4, 2013
Last Verified: August 2013