RCT of an Acceptance-based Behavior Therapy for GAD

NCT00961493 | Completed DMC

• 3 other identifiers: R01MH074589NIH MH074589DSIR 83-ATAS2
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD

  pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

• Hamilton Anxiety Rating Scale

  pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

• Penn State Worry Questionnaire

  pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Secondary Outcomes (2)

• Beck Depression Inventory - II

  pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

• Quality of Life Inventory

  pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Acceptance based behavioral therapy

2

ACTIVE COMPARATOR

Behavioral: Applied relaxation

Interventions

Acceptance based behavioral therapy BEHAVIORAL

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.

1

Applied relaxation BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• bipolar disorder
• psychotic disorders
• substance dependence
• active suicidal intent
• if anxious symptomatology is due to a medical/physical condition

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Lizabeth Roemer, Ph.D.

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: March 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)