Trial record 13 of 34 for:    Open Studies | "Panic Disorder"

Psychotherapy Outcome and Self-selection Effects in Panic Disorder

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014