Somatoform Disorders Clinical Trial
Official title:
Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)
This study will evaluate the effectiveness of an integrated three-part treatment program in improving the quality of care and treatment outcomes of people with hypochondriasis in primary care settings.
Hypochondriasis, which is classified as a type of somatoform disorder, is one of the most
difficult psychiatric disorders to treat. It is prevalent in primary care settings, and is a
major source of suffering for patients and frustration for physicians. People with
hypochondriasis tend to become preoccupied with the fear of having a serious disease,
despite appropriate medical evaluations and reassurance that indicate otherwise. The
disorder usually occurs in episodes lasting from months to years, separated by equally long
periods of quiescence. Existing strategies for treating hypochondriasis include
psychotherapy, medication treatment, and alternative treatments, such as exercise and
electroconvulsive therapy. An effective treatment program should target the needs of both
patients and physicians, as well as the structure of the delivery system. Components of such
a program have been developed, but have not yet been integrated and tested in a clinical
setting. This study will evaluate the effectiveness of an integrated three-part treatment
program in improving hypochondriasis treatment and quality of care outcome in primary care
settings.
Participants in this 6-month, single-blind study will first undergo baseline assessments.
They will then be randomly assigned to partake in either the three-part treatment program or
relaxation response training, in which patients are taught to use muscle relaxation
techniques to reduce stress. Over the course of the study, participants assigned to the
three-part program will attend five self-scheduled, 30-minute sessions of psychoeducational
counseling based on cognitive behavioral therapy principles. Sessions will focus on common
hypochondriacal cognitive distortions and misunderstandings about symptoms, disease, and
medical care. Additionally, the doctors and nurses at the participating hospital will
undergo a training program to improve medical management of patients with hypochondriasis.
The final component of the program will entail implementing an enhanced role for nurse
practitioners to collaborate with primary care physicians in caring for patients with
hypochondriasis. Participants assigned to relaxation response training will attend three
self-scheduled, 1-hour sessions over the course of the study. They will be provided with an
explanation of the physical effects of stress on the body and the purposes of progressive
muscle relaxation training. They will then learn a relaxation technique through direct
instruction, and will practice between sessions. Participants will also use a 20-minute
audio tape to practice once a day, 5 to 7 days a week between clinic visits. All
participants will attend self-scheduled follow-up visits 6 and 12 months following the end
of treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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