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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Applied relaxation and self-control desensitization
Cognitive therapy (CT)
Cognitive-Behavioral Therapy
Sponsored by
Michelle G. Newman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Purely Behavioral therapy

Cognitive-Behavioral Therapy

Cognitive Therapy (CT)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

High End State Function
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

Within-group Change Represented as Cohen's d Effect Sizes
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.

Full Information

First Posted
March 12, 2008
Last Updated
January 24, 2018
Sponsor
Michelle G. Newman
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1. Study Identification

Unique Protocol Identification Number
NCT00635999
Brief Title
A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder
Official Title
Desensitization and Cognitive Therapy in General Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 1991 (undefined)
Primary Completion Date
October 1998 (Actual)
Study Completion Date
October 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle G. Newman

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purely Behavioral therapy
Arm Type
Experimental
Arm Description
Participants will receive treatment with progressive and applied relaxation and self-control desensitization.
Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization
Arm Title
Cognitive Therapy (CT)
Arm Type
Experimental
Arm Description
Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.
Intervention Type
Behavioral
Intervention Name(s)
Applied relaxation and self-control desensitization
Intervention Description
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
Other
Intervention Name(s)
Cognitive therapy (CT)
Intervention Description
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
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
Includes all of the techniques in the other 2 interventions.
Primary Outcome Measure Information:
Title
High End State Function
Description
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)
Time Frame
10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Secondary Outcome Measure Information:
Title
Within-group Change Represented as Cohen's d Effect Sizes
Description
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.
Time Frame
10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, PhD
Organizational Affiliation
Penn State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas D. Borkovec, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary data has been shared.
Citations:
PubMed Identifier
9171808
Citation
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.
Results Reference
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PubMed Identifier
9166642
Citation
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.
Results Reference
background
PubMed Identifier
11132119
Citation
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.
Results Reference
background
PubMed Identifier
11344459
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
12763391
Citation
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.
Results Reference
background
PubMed Identifier
18509873
Citation
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.
Results Reference
background
PubMed Identifier
19187814
Citation
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.
Results Reference
background
PubMed Identifier
20171328
Citation
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.
Results Reference
background
PubMed Identifier
21132075
Citation
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.
Results Reference
background
PubMed Identifier
11952187
Citation
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.
Results Reference
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A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder

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