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A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00635999
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle G. Newman, Penn State University

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

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Applied relaxation and self-control desensitization Other: Cognitive therapy (CT) Behavioral: Cognitive-Behavioral Therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desensitization and Cognitive Therapy in General Anxiety
Study Start Date : October 1991
Actual Primary Completion Date : October 1998
Actual Study Completion Date : October 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Purely Behavioral therapy
Participants will receive treatment with progressive and 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.

Experimental: Cognitive-Behavioral Therapy
Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization
Behavioral: Cognitive-Behavioral Therapy
Includes all of the techniques in the other 2 interventions.

Experimental: Cognitive Therapy (CT)
Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.
Other: Cognitive therapy (CT)
CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.




Primary Outcome Measures :
  1. High End State Function [ Time Frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session ]
    Percentage of participants meeting high end state functioning (e.g., 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)


Secondary Outcome Measures :
  1. Within-group Change Represented as Cohen's d Effect Sizes [ Time Frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session ]
    Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy [or follow-up] mean minus pretherapy mean divided by the pretherapy standard deviation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635999


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

Publications of Results:
Other Publications:
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.

Responsible Party: Michelle G. Newman, Study Director, Penn State University
ClinicalTrials.gov Identifier: NCT00635999     History of Changes
Other Study ID Numbers: R01MH039172-01 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2008    Key Record Dates
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Summary data has been shared.

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders