Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368212
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2006-08-23
Brief Title:
Integrated Treatment Program for Hypochondriasis in Primary Care Settings
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Treating Refractory Symptoms in Primary Care Hypochondriasis Diagnosis Description and Medical Care
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 82-SEPC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH040487 |
| R01MH040487 | NIH | None | None |