NCT01606592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

9.4 years

First QC Date

March 19, 2012

Last Update Submit

March 11, 2021

Conditions

Panic Disorder (With or Without Agoraphobia)

Outcome Measures

Primary Outcomes (3)

  • Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)

    Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination

  • Change in occupational status

    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

    Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination

Secondary Outcomes (4)

  • Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)

    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)

    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)

    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)

    Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination

Study Arms (5)

Randomized Panic Control Treatment

EXPERIMENTAL

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

Behavioral: Panic Control Treatment (PCT)

Randomized Panic-Focused Psychodynamic Psychotherapy

EXPERIMENTAL

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

Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)

Self-selected Panic Control Treatment

EXPERIMENTAL

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

Behavioral: Panic Control Treatment (PCT)

Self-selected Panic-Focussed Psychodynamic Psychotherapy

EXPERIMENTAL

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

Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)

Waiting-list

EXPERIMENTAL

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

Interventions

Panic Control Treatment (PCT)BEHAVIORAL

Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.

Randomized Panic Control TreatmentSelf-selected Panic Control Treatment
Panic-Focused Psychodynamic Psychotherapy (PFPP)BEHAVIORAL

Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.

Randomized Panic-Focused Psychodynamic PsychotherapySelf-selected Panic-Focussed Psychodynamic Psychotherapy
Waiting-listOTHER

Sparse telephone contact during 12 weeks, then re-randomization

Waiting-list

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, SE-221 00, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 34591549DERIVED

  • 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.

    PMID: 33148129DERIVED

  • 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.

    PMID: 30636466DERIVED

  • 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.

    PMID: 25873067DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Rolf Sandell, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

May 25, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2019

Study Completion

February 1, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

SE(1)