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Completed

NCT Number: NCT00961493

RCT of an Acceptance-based Behavior Therapy for GAD

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

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

  2. Hamilton Anxiety Rating Scale

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

  3. Penn State Worry Questionnaire

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

Secondary outcomes

  1. Beck Depression Inventory - II

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

  2. Quality of Life Inventory

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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Boston

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2009
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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