Generalized Anxiety Disorder Clinical Trial
Official title:
Desensitization and Cognitive Therapy in General Anxiety
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.
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