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A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder
This study has been completed.
First Received: March 12, 2008   Last Updated: August 5, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00635999
  Purpose

This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.


Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: Applied relaxation and self-control desensitization
Behavioral: Cognitive behavioral therapy (CBT)
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title: Desensitization and Cognitive Therapy in General Anxiety

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Endstate function within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire [ Time Frame: Measured at Week 13 and Months 6, 12, and 24 follow-ups ] [ Designated as safety issue: No ]
  • Assessor severity of less than or equal to 2 and daily diary of less than or equal to 20 [ Time Frame: Measured at Week 13 and Months 6, 12, and 24 follow-ups ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: October 1991
Study Completion Date: October 1998
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Participants will receive treatment with applied relaxation and self-control desensitization.
Behavioral: Applied relaxation and self-control desensitization
Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.
B: Experimental
Participants will receive treatment with cognitive behavioral therapy.
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CBT will include 14 weekly sessions.
C: Experimental
Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
Behavioral: Applied relaxation and self-control desensitization
Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CBT will include 14 weekly sessions.

Detailed Description:

Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD.

Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each.

During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries.

Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of GAD

Exclusion Criteria:

  • Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
  • Currently receiving therapy for GAD or has previously received CBT
  • Medical contributions to anxiety
  • Currently taking antidepressant medication
  • Current substance abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635999

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Investigators
Study Director: Michelle G. Newman, PhD Penn State University
Principal Investigator: Thomas D. Borkovec, PhD Penn State University
  More Information

Publications:
Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.
Roemer L, Molina S, Borkovec TD. An investigation of worry content among generally anxious individuals. J Nerv Ment Dis. 1997 May;185(5):314-9.
Roemer L, Molina S, Litz BT, Borkovec TD. Preliminary investigation of the role of previous exposure to potentially traumatizing events in generalized anxiety disorder. Depress Anxiety. 1996-1997;4(3):134-8.
Deviliya GJ, Borkovecb TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86.
Schut AJ, Castonguay LG, Borkovec TD. Compulsive checking behaviors in generalized anxiety disorder. J Clin Psychol. 2001 Jun;57(6):705-15.
Stöber, J., & Borkovec, T. D. (2002). Reduced concreteness of worry in generalized anxiety disorder: Findings from a therapy study. Cognitive Therapy and Research, 26, 89-96.
Behar E, Alcaine O, Zuellig AR, Borkovec TD. Screening for generalized anxiety disorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis. J Behav Ther Exp Psychiatry. 2003 Mar;34(1):25-43.
McLaughlin KA, Behar E, Borkovec TD. Family history of psychological problems in generalized anxiety disorder. J Clin Psychol. 2008 Jul;64(7):905-18.
Cassidy, J., Lichtenstein-Phelps, J., Sibrava, N. J., Thomas, C. L., & Borkovec, T. D. (2009). Generalized anxiety disorder: Connections with self-reported attachment. Behavior Therapy, 40, 23-38.

Responsible Party: Penn State University ( Thomas Borkovec, PhD )
Study ID Numbers: R01 MH039172-01
Study First Received: March 12, 2008
Last Updated: August 5, 2009
ClinicalTrials.gov Identifier: NCT00635999     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 10, 2009