Panic Disorder (With or Without Agoraphobia)
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 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.
Interventions
BEHAVIORALPanic Control Treatment (PCT)
Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
BEHAVIORALPanic-Focused Psychodynamic Psychotherapy (PFPP)
Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
OTHERWaiting-list
Sparse telephone contact during 12 weeks, then re-randomization
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 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 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 |
Countries
Sweden
Outcome results
None listed