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

NCT ID: NCT00635999

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-10-31
• Study Completion Date: 1998-10-31

Brief Summary

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

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Purely Behavioral therapy

Participants will receive treatment with progressive and applied relaxation and self-control desensitization.

Group Type: EXPERIMENTAL

Applied relaxation and self-control desensitization

Intervention Type: BEHAVIORAL

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.

Cognitive-Behavioral Therapy

Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization

Group Type: EXPERIMENTAL

Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

Includes all of the techniques in the other 2 interventions.

Cognitive Therapy (CT)

Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.

Group Type: EXPERIMENTAL

Cognitive therapy (CT)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Cognitive-Behavioral Therapy

Includes all of the techniques in the other 2 interventions.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michelle G. Newman

OTHER

Sponsor Role: lead

Responsible Party

Michelle G. Newman

Study Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michelle G. Newman, PhD

Role: STUDY_DIRECTOR

Penn State University

Thomas D. Borkovec, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1097/00005053-199705000-00005.

Reference Type: BACKGROUND

PMID: 9171808 (View on PubMed)

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. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-G.

Reference Type: BACKGROUND

PMID: 9166642 (View on PubMed)

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

Reference Type: BACKGROUND

PMID: 11132119 (View on PubMed)

Schut AJ, Castonguay LG, Borkovec TD. Compulsive checking behaviors in generalized anxiety disorder. J Clin Psychol. 2001 Jun;57(6):705-15. doi: 10.1002/jclp.1043.

Reference Type: BACKGROUND

PMID: 11344459 (View on PubMed)

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.

Reference Type: BACKGROUND

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. doi: 10.1016/s0005-7916(03)00004-1.

Reference Type: BACKGROUND

PMID: 12763391 (View on PubMed)

McLaughlin KA, Behar E, Borkovec TD. Family history of psychological problems in generalized anxiety disorder. J Clin Psychol. 2008 Jul;64(7):905-18. doi: 10.1002/jclp.20497.

Reference Type: BACKGROUND

PMID: 18509873 (View on PubMed)

Cassidy J, Lichtenstein-Phelps J, Sibrava NJ, Thomas CL Jr, Borkovec TD. Generalized anxiety disorder: connections with self-reported attachment. Behav Ther. 2009 Mar;40(1):23-38. doi: 10.1016/j.beth.2007.12.004. Epub 2008 Jun 24.

Reference Type: BACKGROUND

PMID: 19187814 (View on PubMed)

Newman MG, Przeworski A, Fisher AJ, Borkovec TD. Diagnostic comorbidity in adults with generalized anxiety disorder: impact of comorbidity on psychotherapy outcome and impact of psychotherapy on comorbid diagnoses. Behav Ther. 2010 Mar;41(1):59-72. doi: 10.1016/j.beth.2008.12.005. Epub 2009 Jun 8.

Reference Type: BACKGROUND

PMID: 20171328 (View on PubMed)

Newman MG, Fisher AJ. Expectancy/Credibility Change as a Mediator of Cognitive Behavioral Therapy for Generalized Anxiety Disorder: Mechanism of Action or Proxy for Symptom Change? Int J Cogn Ther. 2010 Sep;3:245-261. doi: 10.1521/ijct.2010.3.3.245.

Reference Type: BACKGROUND

PMID: 21132075 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11952187 (View on PubMed)

Other Identifiers

R01MH039172-01

Identifier Type: NIH

Identifier Source: org_study_id

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