Clinical trial NCT01606592: Psychotherapy Outcome and Self-selection Effects in Panic Disorder
Official title: Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder (With or Without Agoraphobia)
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
timeFrame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
measure: Change in occupational status
timeFrame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
measure: Change in absence from work due to sickness
timeFrame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
Secondary outcomes:
measure: Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)
timeFrame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
measure: Change in health care utilization (number of medical contacts, and emergency visits, medication)
timeFrame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
measure: Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)
timeFrame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
measure: Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)
timeFrame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Rolf Sandell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson T, Falkenstrom F, Perrin S, Svensson M, Johansson H, Sandell R. Exploring termination setback in a psychodynamic therapy for panic disorder. J Consult Clin Psychol. 2021 Sep;89(9):762-772. doi: 10.1037/ccp0000678.
citation: Svensson M, Nilsson T, Perrin S, Johansson H, Viborg G, Sandell R. Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why? Psychother Res. 2021 Jun;31(5):644-655. doi: 10.1080/10503307.2020.1839686. Epub 2020 Nov 5.
citation: Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S, Sandell R. Psychometric analysis of the Swedish panic disorder severity scale and its self-report version. Nord J Psychiatry. 2019 Jan;73(1):58-63. doi: 10.1080/08039488.2018.1554699. Epub 2019 Jan 14.
citation: Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.