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Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Not Applicable
Completed
Conditions
Panic Disorder (With or Without Agoraphobia)
Interventions
Behavioral: Panic Control Treatment (PCT)
Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
Other: Waiting-list
Registration Number
NCT01606592
Lead Sponsor
Region Skane
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
216
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Randomized Panic Control TreatmentPanic Control Treatment (PCT)Patients who have been randomized to the randomization condition are assigned to PCT
Randomized Panic-Focused Psychodynamic PsychotherapyPanic-Focused Psychodynamic Psychotherapy (PFPP)Patients who have been randomized to the randomization condition are assigned to PFPP
Self-selected Panic Control TreatmentPanic Control Treatment (PCT)Patients who have been randomized to the self-selection condition choose PCT
Self-selected Panic-Focussed Psychodynamic PsychotherapyPanic-Focused Psychodynamic Psychotherapy (PFPP)Patients who have been randomized to the self-selection condition choose PFPP
Waiting-listWaiting-listPatients 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
Primary Outcome Measures
NameTimeMethod
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 statusGrowth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in absence from work due to sicknessGrowth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
Secondary Outcome Measures
NameTimeMethod
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
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

Trial Locations

Locations (1)

Lund University

🇸🇪

Lund, Sweden

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