Somatoform DisordersPhase 3NCT00050583
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
A Phase 3 study testing Cognitive Behavioral Therapy and CBT in people with Somatoform Disorders, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Somatoform Disorders
- What is being tested?
- Cognitive Behavioral Therapy and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Jul 2005
- 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
- Somatization disorder
Who cannot join
- Bipolar disorder
- Schizophrenia or other psychosis
- Major Depression
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry
Piscataway, New Jersey, 08855-1392
About this study
Official title: Treatment of Somatization in Primary Care
The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.
Read the detailed description
Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.
Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.
- Conditions
- Somatoform Disorders
- Being tested
- Cognitive Behavioral Therapy, CBT
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Ten Weekly Sessions of Manualized CBT
CBTBehavioural
Cognitive Behavioral Therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting Receives: Behavioral: Cognitive Behavioral Therapy; Behavioral: CBT |
| 2 | No intervention | "Treatment as Usual", defined as the use of a consultation letter and traditional primary care management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI Improvement
Measured: Post Treatment
Secondary outcomes (1)
Hamilton Depression
Measured: Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2002 (estimated)
- Study startFeb 2001
- Primary completionJul 2005
- Study completionJul 2005
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 Somatoform DisordersStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers, The State University of New Jersey
- Responsible party
- Principal investigator, Javier I Escobar MD, Rutgers, The State University of New Jersey
- Investigators
- Javier I Escobar, M.D., Principal investigator, Rutgers, The State University of New JerseyMichael A Gara, Ph.D., Study director, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050583
- Sponsor's protocol ID
- R01MH060265
- Other IDs
- R01MH060265
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2002
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. doi: 10.1370/afm.702.
PubMed 17664499
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Somatization in Primary Care
- ClinicalTrials.gov ID
- NCT00050583
- Acronym / sponsor ID
- R01MH060265
- Conditions
- Somatoform Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers, The State University of New Jersey
- Study start
- Feb 2001
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 17 Dec 2002 (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.
The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.
Detailed description
Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.
Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral Therapy, Behavioral: CBT10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting |
| 2 | No intervention | –"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Somatization disorder
Key exclusion criteria (3 listed)
- Bipolar disorder
- Schizophrenia or other psychosis
- Major Depression
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 |
|---|---|---|
| Cognitive Behavioral TherapyTen Weekly Sessions of Manualized CBT | Behavioural | 1 |
| CBTCognitive Behavioral Therapy | Behavioural | 1 |
Primary outcome
CGI Improvement
Time frame: Post Treatment
1 secondary outcome
Hamilton Depression
Time frame: 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 14 Jan 2014.
- Background: PubMed 17664499Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. doi: 10.1370/afm.702.
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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.
Javier I Escobar, M.D. principal investigator
Rutgers, The State University of New Jersey
Michael A Gara, Ph.D. study director
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy and CBT in people with Somatoform Disorders, run by University of Medicine and Dentistry of New Jersey at 1 site 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 1 inclusion and 3 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
CGI Improvement (time frame: 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 NCT00050583, 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 14 Jan 2014.