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Completed

NCT Number: NCT00073632

Acceptance-Based Treatment for Generalized Anxiety Disorder

This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Anxiety and Related Disorders

Boston, Massachusetts, United States

About this study

Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Generalized Anxiety Disorder (GAD)
  • Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study

Exclusion criteria

  • Bipolar disorder, psychotic disorder, or substance dependence

Treatment and study plan

Acceptance based behavioral therapy

Behavioral

Primary outcomes

  1. Clinician Severity Rating from ADIS for GAD

    Time frame: pre, post, 3 mo. f/u, 9 mo. f/u

  2. Penn State Worry Questionnaire

    Time frame: pre-, post-, 3 mo. f/u, 9 mo. f/u

  3. Depression Anxiety and Stress Scales, anxiety and stress subscales

    Time frame: pre-, post-, 3 mo. f/u, 9 mo. f/u

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Boston

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Developing a New Therapy for GAD: Acceptance-Based CBT

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Dec 3, 2003
Registry last updated
Nov 6, 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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