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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder

• Registration Number: NCT02082561
• Lead Sponsor: Florida State University

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-10
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Structured Clinical Interview for the DSM-IV	One Month Follow-up	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	One Month Follow-up	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)	One Month Follow-up	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).

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States