RCT of an Acceptance-based Behavior Therapy for GAD

Generalized Anxiety Disorder Clinical Trial

Official title:

Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961493
• Other study ID #: R01MH074589
• Secondary ID: R01MH074589NIH M
• Status: Completed
• Phase: N/A
• First received: August 18, 2009
• Last updated: June 17, 2013
• Start date: March 2007
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• principal diagnosis of GAD

• at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms

• willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy

• fluent in English

• 18 years or older

Exclusion Criteria:

• bipolar disorder

• psychotic disorders

• substance dependence

• active suicidal intent

• if anxious symptomatology is due to a medical/physical condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Acceptance based behavioral therapy
16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.
• Applied relaxation
16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.

Locations

Country	Name	City	State
United States	Center for Anxiety and Related Disorders at Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Boston	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD		pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up	No
Primary	Hamilton Anxiety Rating Scale		pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up	No
Primary	Penn State Worry Questionnaire		pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up	No
Secondary	Beck Depression Inventory - II		pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up	No
Secondary	Quality of Life Inventory		pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up	No