Panic Disorder (With or Without Agoraphobia) Clinical Trial
Official title:
Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
| NCT number | NCT01606592 |
| Other study ID # | POSE |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | February 2021 |
| Verified date | March 2021 |
| Source | Region Skane |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 216 |
| Est. completion date | February 2021 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Lund University | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Region Skane |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Change in occupational status | Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination | ||
| Primary | 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 | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 |