Psychotherapy Outcome and Self-selection Effects in Panic Disorder

This study is currently recruiting participants.
Verified August 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01606592
First received: March 19, 2012
Last updated: September 4, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Panic Disorder (With or Without Agoraphobia)
Behavioral: Panic Control Treatment (PCT)
Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
Other: Waiting-list
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997) [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]
  • Change in occupational status [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]
  • Change in absence from work due to sickness [ Time Frame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985) [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]
  • Change in health care utilization (number of medical contacts, and emergency visits, medication) [ Time Frame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]
  • Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000) [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]
  • Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979) [ Time Frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: January 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606592

Contacts
Contact: Rolf Sandell, PhD +46 708 607997 rolf.sandell@liu.se
Contact: Thomas Nilsson, Psychologist +46 701 431343 thomas.k.nilsson@skane.se

Locations
Sweden
Lund University Recruiting
Lund, Sweden, SE-221 00
Principal Investigator: Rolf Sandell, PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Rolf Sandell, PhD Lund University
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01606592     History of Changes
Other Study ID Numbers: POSE
Study First Received: March 19, 2012
Last Updated: September 4, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Additional relevant MeSH terms:
Agoraphobia
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014