Relaxation response training
BehavioralThe control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
Other names: Relaxation and Stress Reduction
NCT Number: NCT00368212
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Harvard Vanguard Medical Associates, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
Other names: Relaxation and Stress Reduction
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 names: Educational Counseling
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Brigham and Women's Hospital
Other
Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01119469
Hypochondriasis, Mental Disorders
Frankfurt am Main, Hesse, Germany
View Trial DetailsNCT01158430
Hypochondriasis, Mental Disorders
Aarhus C, Denmark
View Trial DetailsNCT00959452
Hypochondriasis, Mental Disorders
Bergen, Norway
View Trial DetailsNCT04921280
Health Anxiety, Hypochondriacal Disorder, Unspecified
Stockholm, Sweden
View Trial Details