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

• 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 ]

• Endstate function within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory (STAI-T), 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 ]

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

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.

• 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.

• Experimental: A
  Participants will receive treatment with applied relaxation and self-control desensitization.
  Intervention: Behavioral: Applied relaxation and self-control desensitization
• Experimental: B
  Participants will receive treatment with cognitive behavioral therapy.
  Intervention: Behavioral: Cognitive behavioral therapy (CBT)
• Experimental: C
  Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
  Interventions:

  • Behavioral: Applied relaxation and self-control desensitization
  • Behavioral: Cognitive behavioral therapy (CBT)

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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