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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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ClinicalTrials.gov Identifier: NCT02082561
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Norman Schmidt, 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.

Condition or disease Intervention/treatment Phase
Panic Disorder Generalized Anxiety Disorder Social Anxiety Disorder Behavioral: Transdiagnostic Treatment (F-SET) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Transdiagnostic Treatment (F-SET)
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)
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.

No Intervention: Waitlist
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.



Primary Outcome Measures :
  1. The Structured Clinical Interview for the DSM-IV [ Time Frame: 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).

  2. Clinician Global Impressions Scale (CGI) - Severity of Illness Subscale [ Time Frame: 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

  3. Work and Social Adjustment Scale (WSAS) [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082561


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Investigators
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Principal Investigator: Norman B Schmidt, Ph.D Florida State University
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Responsible Party: Norman Schmidt, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT02082561    
Other Study ID Numbers: Florida State University
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by Norman Schmidt, Florida State University:
transdiagnostic treatment
cognitive behavior therapy
anxiety
panic disorder
generalized anxiety disorder
social anxiety disorder
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Panic Disorder
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders