Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Panic Disorder (With or Without Agoraphobia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type OTHER

Sparse telephone contact during 12 weeks, then re-randomization

Interventions

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Panic Control Treatment (PCT)

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

Intervention Type BEHAVIORAL

Panic-Focused Psychodynamic Psychotherapy (PFPP)

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

Intervention Type BEHAVIORAL

Waiting-list

Sparse telephone contact during 12 weeks, then re-randomization

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No