Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder (With or Without Agoraphobia)
• Intervention / Treatment: Behavioral: Panic Control Treatment (PCT); Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP); Other: Waiting-list

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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-221 00
    • Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Panic Control Treatment; Patients who have been randomized to the randomization condition are assigned to PCT	Behavioral: Panic Control Treatment (PCT); Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
Experimental: Randomized Panic-Focused Psychodynamic Psychotherapy; Patients who have been randomized to the randomization condition are assigned to PFPP	Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP); Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
Experimental: Self-selected Panic Control Treatment; Patients who have been randomized to the self-selection condition choose PCT	Behavioral: Panic Control Treatment (PCT); Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
Experimental: Self-selected Panic-Focussed Psychodynamic Psychotherapy; Patients who have been randomized to the self-selection condition choose PFPP	Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP); Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
Experimental: Waiting-list; Patients 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	Other: Waiting-list; Sparse telephone contact during 12 weeks, then re-randomization

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 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
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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Rolf Sandell, PhD, Lund University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Agoraphobia
• Other Study ID Numbers: POSE