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Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Primary Purpose

Panic Disorder (With or Without Agoraphobia)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Panic Control Treatment (PCT)
Panic-Focused Psychodynamic Psychotherapy (PFPP)
Waiting-list
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder (With or Without Agoraphobia)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A Diagnostic and Statistical Manual (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

Sites / Locations

  • Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Randomized Panic Control Treatment

Randomized Panic-Focused Psychodynamic Psychotherapy

Self-selected Panic Control Treatment

Self-selected Panic-Focussed Psychodynamic Psychotherapy

Waiting-list

Arm Description

Patients who have been randomized to the randomization condition are assigned to PCT

Patients who have been randomized to the randomization condition are assigned to PFPP

Patients who have been randomized to the self-selection condition choose PCT

Patients who have been randomized to the self-selection condition choose PFPP

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

Outcomes

Primary Outcome Measures

Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
Change in occupational status
Change in absence from work due to sickness

Secondary Outcome Measures

Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)
Change in health care utilization (number of medical contacts, and emergency visits, medication)
Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)
Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)

Full Information

First Posted
March 19, 2012
Last Updated
March 11, 2021
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01606592
Brief Title
Psychotherapy Outcome and Self-selection Effects in Panic Disorder
Official Title
Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder (With or Without Agoraphobia)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Panic Control Treatment
Arm Type
Experimental
Arm Description
Patients who have been randomized to the randomization condition are assigned to PCT
Arm Title
Randomized Panic-Focused Psychodynamic Psychotherapy
Arm Type
Experimental
Arm Description
Patients who have been randomized to the randomization condition are assigned to PFPP
Arm Title
Self-selected Panic Control Treatment
Arm Type
Experimental
Arm Description
Patients who have been randomized to the self-selection condition choose PCT
Arm Title
Self-selected Panic-Focussed Psychodynamic Psychotherapy
Arm Type
Experimental
Arm Description
Patients who have been randomized to the self-selection condition choose PFPP
Arm Title
Waiting-list
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Panic Control Treatment (PCT)
Intervention Description
Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
Intervention Type
Behavioral
Intervention Name(s)
Panic-Focused Psychodynamic Psychotherapy (PFPP)
Intervention Description
Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
Intervention Type
Other
Intervention Name(s)
Waiting-list
Intervention Description
Sparse telephone contact during 12 weeks, then re-randomization
Primary Outcome Measure Information:
Title
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
Title
Change in occupational status
Time Frame
Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A Diagnostic and Statistical Manual (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Sandell, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
ZIP/Postal Code
SE-221 00
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34591549
Citation
Nilsson T, Falkenstrom F, Perrin S, Svensson M, Johansson H, Sandell R. Exploring termination setback in a psychodynamic therapy for panic disorder. J Consult Clin Psychol. 2021 Sep;89(9):762-772. doi: 10.1037/ccp0000678.
Results Reference
derived
PubMed Identifier
33148129
Citation
Svensson M, Nilsson T, Perrin S, Johansson H, Viborg G, Sandell R. Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why? Psychother Res. 2021 Jun;31(5):644-655. doi: 10.1080/10503307.2020.1839686. Epub 2020 Nov 5.
Results Reference
derived
PubMed Identifier
30636466
Citation
Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S, Sandell R. Psychometric analysis of the Swedish panic disorder severity scale and its self-report version. Nord J Psychiatry. 2019 Jan;73(1):58-63. doi: 10.1080/08039488.2018.1554699. Epub 2019 Jan 14.
Results Reference
derived
PubMed Identifier
25873067
Citation
Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.
Results Reference
derived

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Psychotherapy Outcome and Self-selection Effects in Panic Disorder

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