Somatization DisorderPhase 2NCT00149760
Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
A Phase 2 study testing Augmented Standard Medical Care and Cognitive-Affective Behavior Therapy in people with Somatization Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Somatization Disorder
- What is being tested?
- Augmented Standard Medical Care and Cognitive-Affective Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Feb 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for somatization disorder
- Available for follow-up over the ensuing 18 months
- English-speaking
Who cannot join
- Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
- Active suicidal ideation
- Unstable major medical condition
- Plans to engage in additional psychotherapy during the first 6 months after enrollment
- Current use of any medication that has not been stabilized for the previous 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
Official title: Cognitive Affective Behavior Therapy for Somatization
This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Read the detailed description
Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.
- Conditions
- Somatization Disorder
- Being tested
- Augmented Standard Medical Care, Cognitive-Affective Behavior Therapy
- Keywords
- Cognitive Behavior Therapy, Treatment Outcome, Health Care Utilization, Somatization Disorder, Somatoform Disorder
- Medical subject headings
- Somatoform Disorders, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Standard Medical CareBehavioural
Also called Psychiatric consultation letter sent to primary physician
Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Cognitive-Affective Behavior TherapyBehavioural
Also called Emotionally-Focused Cognitive-Behavioral Therapy
Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
| Study group | Role | What they receive |
|---|---|---|
| Augmented Standard Medical Care | Active comparator | Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician. Receives: Behavioral: Augmented Standard Medical Care |
| Cognitive-Affective Behavior Therapy | Experimental | Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care. Receives: Behavioral: Cognitive-Affective Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale for Somatization Disorder
Measured: Measured at baseline and Months 4, 10, and 16
Secondary outcomes (2)
Physical functioning
Measured: Measured at baseline and Months 4, 10, and 16
Health care utilization
Measured: Measured between Months 4 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Somatization DisorderStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lesley A. Allen, PhD, Principal investigator, Department of Psychiatry, Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149760
- Sponsor's protocol ID
- R21MH066831
- Other IDs
- R21MH066831, DAHBR 96-BHC
- Status last verified
- Feb 2014
- First submitted
- 6 Sep 2005
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen LA, Woolfolk RL, Lehrer PM, Gara MA, Escobar JI. Cognitive behavior therapy for somatization disorder: a preliminary investigation. J Behav Ther Exp Psychiatry. 2001 Jun;32(2):53-62. doi: 10.1016/s0005-7916(01)00020-9.
PubMed 11764061Allen LA, Escobar JI, Lehrer PM, Gara MA, Woolfolk RL. Psychosocial treatments for multiple unexplained physical symptoms: a review of the literature. Psychosom Med. 2002 Nov-Dec;64(6):939-50. doi: 10.1097/01.psy.0000024231.11538.8f.
PubMed 12461199Allen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380.
Allen LA, Woolfolk RL, Escobar JI, Gara MA, Hamer RM. Cognitive-behavioral therapy for somatization disorder: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1512-8. doi: 10.1001/archinte.166.14.1512.
PubMed 16864762
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Affective Behavior Therapy for Somatization
- ClinicalTrials.gov ID
- NCT00149760
- Acronym / sponsor ID
- R21MH066831
- Conditions
- Somatization Disorder
- Keywords
- Cognitive Behavior Therapy, Treatment Outcome, Health Care Utilization, Somatization Disorder, Somatoform Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2003
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Sep 2005 (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 examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Detailed description
Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Standard Medical Care | Active comparator | Behavioral: Augmented Standard Medical CareParticipants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician. |
| Cognitive-Affective Behavior Therapy | Experimental | Behavioral: Cognitive-Affective Behavior TherapyParticipants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for somatization disorder
- Available for follow-up over the ensuing 18 months
- English-speaking
Key exclusion criteria (5 listed)
- Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
- Active suicidal ideation
- Unstable major medical condition
- Plans to engage in additional psychotherapy during the first 6 months after enrollment
- Current use of any medication that has not been stabilized for the previous 2 months
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 |
|---|---|---|
| Augmented Standard Medical CareAlso: Psychiatric consultation letter sent to primary physicianParticipants' physicians will receive a letter making specific treatment recommendations for primary care treatment. | Behavioural | Augmented Standard Medical Care |
| Cognitive-Affective Behavior TherapyAlso: Emotionally-Focused Cognitive-Behavioral TherapyIndividually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care | Behavioural | Cognitive-Affective Behavior Therapy |
Primary outcome
Clinical Global Impression Scale for Somatization Disorder
Time frame: Measured at baseline and Months 4, 10, and 16
2 secondary outcomes
Physical functioning
Time frame: Measured at baseline and Months 4, 10, and 16
Health care utilization
Time frame: Measured between Months 4 and 16
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 20 Feb 2014.
- Background: PubMed 11764061Allen LA, Woolfolk RL, Lehrer PM, Gara MA, Escobar JI. Cognitive behavior therapy for somatization disorder: a preliminary investigation. J Behav Ther Exp Psychiatry. 2001 Jun;32(2):53-62. doi: 10.1016/s0005-7916(01)00020-9.
- Background: PubMed 12461199Allen LA, Escobar JI, Lehrer PM, Gara MA, Woolfolk RL. Psychosocial treatments for multiple unexplained physical symptoms: a review of the literature. Psychosom Med. 2002 Nov-Dec;64(6):939-50. doi: 10.1097/01.psy.0000024231.11538.8f.
- BackgroundAllen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380.
- Background: PubMed 16864762Allen LA, Woolfolk RL, Escobar JI, Gara MA, Hamer RM. Cognitive-behavioral therapy for somatization disorder: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1512-8. doi: 10.1001/archinte.166.14.1512.
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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.
Lesley A. Allen, PhD principal investigator
Department of Psychiatry, Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Augmented Standard Medical Care and Cognitive-Affective Behavior Therapy in people with Somatization Disorder, run by Rutgers, The State University 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 3 inclusion and 5 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 20 Feb 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical Global Impression Scale for Somatization Disorder (time frame: Measured at baseline and Months 4, 10, and 16). 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 NCT00149760, which also lists 4 linked publications.
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 20 Feb 2014.