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Clinical Trials/NCT00635999
NCT00635999CompletedNot Applicable

Desensitization and Cognitive Therapy in General Anxiety

Michelle G. Newman1 site in 1 country76 target enrollmentStarted: October 1, 1991Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
76
Locations
1
Primary Endpoint
High End State Function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Purely Behavioral therapy

Experimental

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

Intervention: Applied relaxation and self-control desensitization (Behavioral)

Cognitive-Behavioral Therapy

Experimental

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

Intervention: Cognitive-Behavioral Therapy (Behavioral)

Cognitive Therapy (CT)

Experimental

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

Intervention: Cognitive therapy (CT) (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • Within-group Change Represented as Cohen's d Effect Sizes(10-14 days after last therapy session and months 6, 12, and 24 following last therapy session)

Investigators

Sponsor
Michelle G. Newman
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Michelle G. Newman

Study Director

Penn State University

Study Sites (1)

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