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Psychotherapy Outcome and Self-selection Effects in Panic Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606592
First Posted: May 25, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Region Skane
  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
Panic Disorder (With or Without Agoraphobia) Behavioral: Panic Control Treatment (PCT) Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP) Other: Waiting-list

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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 ]
  • Change in occupational status [ Time Frame: 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 [ Time Frame: 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:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 216
Actual Study Start Date: January 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606592


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01606592     History of Changes
Other Study ID Numbers: POSE
First Submitted: March 19, 2012
First Posted: May 25, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

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