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False Safety Behavior Elimination Therapy: A Randomized Study of a Brief Individual Transdiagnostic Treatment for Anxiety Disorders

Primary Purpose

Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transdiagnostic Treatment (F-SET)
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring transdiagnostic treatment, cognitive behavior therapy, anxiety, panic disorder, generalized anxiety disorder, social anxiety disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must have a primary diagnosis of panic disorder, generalized anxiety disorder, or social anxiety disorder.
  • No change in medication type or dose during the 12 weeks prior to treatment

Exclusion Criteria:

  • Current or past schizophrenia, bipolar disorder, or organic mental disorder

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transdiagnostic Treatment (F-SET)

Waitlist

Arm Description

F-SET treatment consisted of five weekly individual sessions (approximately 50 minutes each). The F-SET protocol is consistent with current CBT protocols for anxiety disorders.

The waitlist control condition was comprised of patients randomly assigned to the waitlist condition (WL). Individuals in this condition were reassessed after five weeks and were then offered treatment, but were no longer followed.

Outcomes

Primary Outcome Measures

The Structured Clinical Interview for the DSM-IV
Structured Clinical Interview for the DSM-IV (SCID-IV). The SCID-IV (Spitzer, Gibbon, & Williams, 1996) is a structured diagnostic interview designed to provide detailed coverage of Axis-I disorders. The SCID-IV has been shown to be a reliable and valid measure of the Diagnostic and Statistical Manual of Mental Disorders (fourth edition-text revision; American Psychiatric Association, 2000) Axis I disorders (Zanarini et al., 2000).
Clinician Global Impressions Scale (CGI) - Severity of Illness Subscale
Clinician Global Impressions Scale (CGI) - Severity of Illness Subscale. The CGI (Guy, 1976) is a widely used clinician-rated measure of global impressions. The severity of illness subscale from the CGI is composed of a 7-point scale (ranging from 0=not at all ill to 6=among the most extremely ill patients) and is used to assess
Work and Social Adjustment Scale (WSAS)
Work and Social Adjustment Scale (WSAS). The WSAS is a 5-item descriptive measure of subjective interference in various life domains (i.e., work, home management, private leisure, and family relationships). Interference in the past week is rated from 0 (not at all interfering) to 8 (severe interference). The WSAS has demonstrated good internal consistency and has been successfully used in previous studies (e.g., Brown & Barlow, 1995; Ellard, Fairholme, Boisseau, Farchione, & Barlow, 2010). The WSAS was used as an index of overall disability and impairment. The WSAS demonstrated good internal consistency in the present sample (mean inter-item correlation = .28).

Secondary Outcome Measures

Full Information

First Posted
March 6, 2014
Last Updated
March 6, 2014
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT02082561
Brief Title
False Safety Behavior Elimination Therapy: A Randomized Study of a Brief Individual Transdiagnostic Treatment for Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder (PD). We hypothesized that the F-SET protocol would produce better overall outcome relative to a waitlist control.
Detailed Description
The aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder (PD). Four primary hypotheses were evaluated in the current study: (1) the F-SET protocol would produce better overall outcome relative to a waitlist control, (2) the F-SET protocol would yield clinically significant improvement of primary diagnosis symptoms as well as secondary diagnosis symptoms, (3) the F-SET protocol would create treatment improvement that is maintained during a 1 month follow-up interval and (4) given that reduction of safety aid use is the key mechanism of change in the F-SET treatment, a reduction in safety aid use will mediate the relationship between pre and post treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder
Keywords
transdiagnostic treatment, cognitive behavior therapy, anxiety, panic disorder, generalized anxiety disorder, social anxiety disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transdiagnostic Treatment (F-SET)
Arm Type
Experimental
Arm Description
F-SET treatment consisted of five weekly individual sessions (approximately 50 minutes each). The F-SET protocol is consistent with current CBT protocols for anxiety disorders.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
The waitlist control condition was comprised of patients randomly assigned to the waitlist condition (WL). Individuals in this condition were reassessed after five weeks and were then offered treatment, but were no longer followed.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic Treatment (F-SET)
Intervention Description
F-SET treatment consisted of five weekly individual sessions (approximately 50 minutes each). The participants learn to techniques and skills to help them reduce their anxiety. F-SET protocol is consistent with current CBT protocols for anxiety disorders.
Primary Outcome Measure Information:
Title
The Structured Clinical Interview for the DSM-IV
Description
Structured Clinical Interview for the DSM-IV (SCID-IV). The SCID-IV (Spitzer, Gibbon, & Williams, 1996) is a structured diagnostic interview designed to provide detailed coverage of Axis-I disorders. The SCID-IV has been shown to be a reliable and valid measure of the Diagnostic and Statistical Manual of Mental Disorders (fourth edition-text revision; American Psychiatric Association, 2000) Axis I disorders (Zanarini et al., 2000).
Time Frame
One Month Follow-up
Title
Clinician Global Impressions Scale (CGI) - Severity of Illness Subscale
Description
Clinician Global Impressions Scale (CGI) - Severity of Illness Subscale. The CGI (Guy, 1976) is a widely used clinician-rated measure of global impressions. The severity of illness subscale from the CGI is composed of a 7-point scale (ranging from 0=not at all ill to 6=among the most extremely ill patients) and is used to assess
Time Frame
One Month Follow-up
Title
Work and Social Adjustment Scale (WSAS)
Description
Work and Social Adjustment Scale (WSAS). The WSAS is a 5-item descriptive measure of subjective interference in various life domains (i.e., work, home management, private leisure, and family relationships). Interference in the past week is rated from 0 (not at all interfering) to 8 (severe interference). The WSAS has demonstrated good internal consistency and has been successfully used in previous studies (e.g., Brown & Barlow, 1995; Ellard, Fairholme, Boisseau, Farchione, & Barlow, 2010). The WSAS was used as an index of overall disability and impairment. The WSAS demonstrated good internal consistency in the present sample (mean inter-item correlation = .28).
Time Frame
One Month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must have a primary diagnosis of panic disorder, generalized anxiety disorder, or social anxiety disorder. No change in medication type or dose during the 12 weeks prior to treatment Exclusion Criteria: Current or past schizophrenia, bipolar disorder, or organic mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman B Schmidt, Ph.D
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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False Safety Behavior Elimination Therapy: A Randomized Study of a Brief Individual Transdiagnostic Treatment for Anxiety Disorders

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