Integrated Treatment Program for Hypochondriasis in Primary Care Settings
Condition: Hypochondriasis; Somatoform Disorders
MeSH terms: Somatoform Disorders; Hypochondriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Relaxation response training; Psychoeducational counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.; Patients will receive five sessions of psychoeducational counseling from the nurse who works with the primary care physicians. Patients who are interested in continuing treatment or who have not responded to this first treatment step will then be referred for the second step, cognitive behavioral therapy (CBT), for more intensive treatment.
Other intervention name(s): Relaxation and Stress Reduction; Educational Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatization; Refractory Symptoms