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

NCT02082561 | Completed

• 1 other identifier: Florida State University
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Keywords

transdiagnostic treatment; cognitive behavior therapy; anxiety; panic disorder; generalized anxiety disorder; social anxiety disorder

Outcome Measures

Primary Outcomes (3)

• 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).

  One Month Follow-up

• 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

  One Month Follow-up

• 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).

  One Month Follow-up

Study Arms (2)

Transdiagnostic Treatment (F-SET)

EXPERIMENTAL

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.

Behavioral: Transdiagnostic Treatment (F-SET)

Waitlist

NO INTERVENTION

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.

Interventions

Transdiagnostic Treatment (F-SET) BEHAVIORAL

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.

Transdiagnostic Treatment (F-SET)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Panic Disorder; Generalized Anxiety Disorder; Phobia, Social; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Norman B Schmidt, Ph.D

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

US (1)