Stress Disorders, Post-TraumaticNCT00053690
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
A study testing Cognitive Behavior Treatment in people with Stress Disorders, Post-Traumatic, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive Behavior Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Dec 2004
- Phase
- Interventional
- 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
- Post Traumatic Stress Disorder
- New Hampshire definition of SMI plus DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
- Case management services and contact with a case manager at least twice a week
Who cannot join
- Alcohol or drug dependence
- Hospitalization or suicide attempt in the past 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Mental Health Centers in NH
Claremont, New Hampshire, 03301
About this study
Official title: Cognitive-Behavioral Treatment of PTSD in SMI Clients
The purpose of this study is to develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses.
Read the detailed description
Despite the progress in treating PTSD in the general population and the elevated prevalence of PTSD in people with severe mental illness (SMI), there are no empirically validated treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD symptoms, and improve quality of life.
Participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. Standard care for SMI includes medication, case management, and psychosocial treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. Participants' knowledge of PTSD and beliefs about the world are also measured. Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00494650
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Cognitive Behavior Treatment
- Keywords
- Comorbidity, Schizophrenia, Bipolar Disorder, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Schizophrenia, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TreatmentBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2003 (estimated)
- Study startJan 2002
- Study completionDec 2004
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 Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Kim Mueser, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical CenterStanley Rosenberg, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053690
- Sponsor's protocol ID
- R01MH064662-01
- Other IDs
- R01MH064662-01, DSIR AT-SP
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2003
- Last updated
- 10 Sep 2013
- Results posted
- No
Publications
Mueser KT, McGurk SR, Xie H, Bolton EE, Jankowski MK, Lu W, Rosenberg SD, Wolfe R. Neuropsychological predictors of response to cognitive behavioral therapy for posttraumatic stress disorder in persons with severe mental illness. Psychiatry Res. 2018 Jan;259:110-116. doi: 10.1016/j.psychres.2017.10.016. Epub 2017 Oct 6.
PubMed 29040946
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Treatment of PTSD in SMI Clients
- ClinicalTrials.gov ID
- NCT00053690
- Acronym / sponsor ID
- R01MH064662-01
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Comorbidity, Schizophrenia, Bipolar Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2002
- Study completion
- Dec 2004
- First posted
- 5 Feb 2003 (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 develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses.
Detailed description
Despite the progress in treating PTSD in the general population and the elevated prevalence of PTSD in people with severe mental illness (SMI), there are no empirically validated treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD symptoms, and improve quality of life.
Participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. Standard care for SMI includes medication, case management, and psychosocial treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. Participants' knowledge of PTSD and beliefs about the world are also measured. Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00494650
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post Traumatic Stress Disorder
- New Hampshire definition of SMI plus DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
- Case management services and contact with a case manager at least twice a week
Key exclusion criteria (2 listed)
- Alcohol or drug dependence
- Hospitalization or suicide attempt in the past 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 |
|---|---|---|
| Cognitive Behavior Treatment | Behavioural | – |
Primary outcome
Not reported in the source record.
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 10 Sep 2013.
- Derived from this study: PubMed 29040946Mueser KT, McGurk SR, Xie H, Bolton EE, Jankowski MK, Lu W, Rosenberg SD, Wolfe R. Neuropsychological predictors of response to cognitive behavioral therapy for posttraumatic stress disorder in persons with severe mental illness. Psychiatry Res. 2018 Jan;259:110-116. doi: 10.1016/j.psychres.2017.10.016. Epub 2017 Oct 6.
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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.
Kim Mueser, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
Stanley Rosenberg, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Treatment in people with Stress Disorders, Post-Traumatic, run by Dartmouth-Hitchcock Medical Center 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 2 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 10 Sep 2013. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00053690, 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 10 Sep 2013.