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

NCT ID: NCT02082561

Last Updated: 2014-03-10

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Panic Disorder Generalized Anxiety Disorder Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transdiagnostic Treatment (F-SET)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Norman Schmidt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman B Schmidt, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Florida State University

Identifier Type: -

Identifier Source: org_study_id

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