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

March 19, 2012
September 4, 2013
January 2010
June 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01606592 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 & Åsberg, 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Panic Disorder (With or Without Agoraphobia)
  • 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.
  • Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
    Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
  • Other: Waiting-list
    Sparse telephone contact during 12 weeks, then re-randomization
  • Experimental: Randomized Panic Control Treatment
    Patients who have been randomized to the randomization condition are assigned to PCT
    Intervention: Behavioral: Panic Control Treatment (PCT)
  • Experimental: Randomized Panic-Focused Psychodynamic Psychotherapy
    Patients who have been randomized to the randomization condition are assigned to PFPP
    Intervention: Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
  • Experimental: Self-selected Panic Control Treatment
    Patients who have been randomized to the self-selection condition choose PCT
    Intervention: Behavioral: Panic Control Treatment (PCT)
  • Experimental: Self-selected Panic-Focussed Psychodynamic Psychotherapy
    Patients who have been randomized to the self-selection condition choose PFPP
    Intervention: Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
  • 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
    Intervention: Other: Waiting-list
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
June 2017
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Rolf Sandell, PhD +46 708 607997 rolf.sandell@liu.se
Contact: Thomas Nilsson, Psychologist +46 701 431343 thomas.k.nilsson@skane.se
Sweden
 
NCT01606592
POSE
Yes
Region Skane
Region Skane
Not Provided
Principal Investigator: Rolf Sandell, PhD Lund University
Region Skane
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP