Psychotherapy Outcome and Self-selection Effects in Panic Disorder - Full Text View

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 differences 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:

MedlinePlus related topics: Panic Disorder

U.S. FDA Resources

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 & 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 ]

Estimated Enrollment:	216
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2014 (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

Locations

Sweden
Lund University
Lund, Sweden, SE-221 00

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:	May 23, 2012
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 June 17, 2013