HypochondriasisPhase 3NCT00368212
Integrated Treatment Program for Hypochondriasis in Primary Care Settings
A Phase 3 study testing Relaxation response training and Psychoeducational counseling in people with Hypochondriasis and Somatoform Disorders, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypochondriasis, Somatoform Disorders
- What is being tested?
- Relaxation response training and Psychoeducational counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has received primary medical care at Harvard Vanguard Medical Associates (HVMA) for at least 12 months prior to study entry
- Expects to continue receiving care from the current primary care physician for at least the next 12 months
- Meets requirement for average hypochondriasis screening score
- Able to speak and read English
- Falls within the top 20% of utilizers of health care services in the HVMA system over the past year
- Has attended no more than one visit to any specialist over the year prior to study entry
Who cannot join
- Psychiatric illness (e.g., psychosis, dementia, suicidal ideation)
- Somatoform pain disorder or currently receiving treatment for somatoform pain disorder (e.g., relaxation training)
- History of alcohol or substance abuse or dependence within the 12 months prior to study entry
- Terminal medical illness or major medical illness expected to worsen significantly over the next year
- Ongoing symptom-contingent litigation against HVMA
- Monetary compensation for medical disability
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02472
Harvard Vanguard Medical Associates
Cambridge, Massachusetts, 02138
About this study
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.
Read the 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.
- Conditions
- Hypochondriasis, Somatoform Disorders
- Being tested
- Relaxation response training, Psychoeducational counseling
- Keywords
- Somatization, Refractory Symptoms
- Medical subject headings
- Hypochondriasis, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation response trainingBehavioural
Also called Relaxation and Stress Reduction
The control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist.
Psychoeducational counselingBehavioural
Also called Educational Counseling
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive psychoeducational counseling (termed "health care counseling") Receives: Behavioral: Psychoeducational counseling |
| 2 | Active comparator | Participants will receive relaxation response training Receives: Behavioral: Relaxation response training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whitely Index
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Secondary outcomes (5)
Health Anxiety Inventory
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Modified Cognitions Questionnaire
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Somatic Symptom Inventory
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Functional Status Questionnaire
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Client Satisfaction Index
Measured: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startMay 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital
- Investigators
- Arthrur J. Barsky, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368212
- Sponsor's protocol ID
- R01MH040487
- Other IDs
- R01MH040487, DSIR 82-SEPC
- Status last verified
- Mar 2013
- First submitted
- 23 Aug 2006
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Barsky AJ, Ahern DK, Bauer MR, Nolido N, Orav EJ. A randomized trial of treatments for high-utilizing somatizing patients. J Gen Intern Med. 2013 Nov;28(11):1396-404. doi: 10.1007/s11606-013-2392-6. Epub 2013 Mar 14.
PubMed 23494213
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)
- ClinicalTrials.gov ID
- NCT00368212
- Acronym / sponsor ID
- R01MH040487
- Conditions
- Hypochondriasis, Somatoform Disorders
- Keywords
- Somatization, Refractory Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Psychoeducational counselingParticipants will receive psychoeducational counseling (termed "health care counseling") |
| 2 | Active comparator | Behavioral: Relaxation response trainingParticipants will receive relaxation response training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has received primary medical care at Harvard Vanguard Medical Associates (HVMA) for at least 12 months prior to study entry
- Expects to continue receiving care from the current primary care physician for at least the next 12 months
- Meets requirement for average hypochondriasis screening score
- Able to speak and read English
- Falls within the top 20% of utilizers of health care services in the HVMA system over the past year
Key exclusion criteria (6 listed)
- Psychiatric illness (e.g., psychosis, dementia, suicidal ideation)
- Somatoform pain disorder or currently receiving treatment for somatoform pain disorder (e.g., relaxation training)
- History of alcohol or substance abuse or dependence within the 12 months prior to study entry
- Terminal medical illness or major medical illness expected to worsen significantly over the next year
- Ongoing symptom-contingent litigation against HVMA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation response trainingAlso: Relaxation and Stress ReductionThe control treatment is relaxation training or attention control. This will be taught in three, 1-hour sessions with a trained therapist. | Behavioural | 2 |
| Psychoeducational counselingAlso: Educational CounselingPatients 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. | Behavioural | 1 |
Primary outcome
Whitely Index
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
5 secondary outcomes
Health Anxiety Inventory
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Modified Cognitions Questionnaire
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Somatic Symptom Inventory
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Functional Status Questionnaire
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Client Satisfaction Index
Time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
- Derived from this study: PubMed 23494213Barsky AJ, Ahern DK, Bauer MR, Nolido N, Orav EJ. A randomized trial of treatments for high-utilizing somatizing patients. J Gen Intern Med. 2013 Nov;28(11):1396-404. doi: 10.1007/s11606-013-2392-6. Epub 2013 Mar 14.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthrur J. Barsky, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Relaxation response training and Psychoeducational counseling in people with Hypochondriasis and Somatoform Disorders, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whitely Index (time frame: Measured immediately post-treatment and at Months 6 and 12 post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.