Post-Traumatic Stress DisorderPhase 3TREMNCT00183716
The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
A Phase 3 study testing Trauma Recovery and Empowerment Model (TREM) in people with Post-Traumatic Stress Disorder and Mental Disorders, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder, Mental Disorders, Depression
- What is being tested?
- Trauma Recovery and Empowerment Model (TREM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Nov 2007
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of physical and/or sexual abuse
- Diagnosis of a severe mental disorder
- Diagnosis of PTSD with a symptom severity score of 21 or higher
Who cannot join
- Severe developmental disabilities or organic brain damage
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The North Baltimore Center
Baltimore, Maryland, 21218
Community Connections
Washington D.C., District of Columbia, 20003
About this study
Official title: An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model
This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse.
Read the detailed description
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. Rates of PTSD are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression, substance abuse, and poor overall health. In turn, these issues lead to high rates of utilization of mental health services. Unfortunately, there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings. Trauma Recovery and Empowerment Model (TREM) is a group-based intervention that addresses PTSD and other closely related consequences of sexual and physical abuse among women with severe mental disorders. This study will determine the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental disorders who have experienced sexual or physical abuse.
Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months. Usual care will include medication, case management, and therapy administered by a primary clinician. Participants assigned to usual care will report to the study site at least once a week, or as often as necessary. Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary. In addition, TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame. PTSD symptom severity, trauma beliefs, depressive symptoms, substance use, and mental health service utilization will be measured at Months 6, 12, and 18 for all participants.
- Conditions
- Post-Traumatic Stress Disorder, Mental Disorders, Depression
- Being tested
- Trauma Recovery and Empowerment Model (TREM), Usual care
- Keywords
- PTSD, Physical Abuse, Sexual Abuse, Women, Trauma, Group Therapy, Substance Abuse
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders, Depression, Wounds and Injuries, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Recovery and Empowerment Model (TREM)Behavioural
TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment.
Usual careBehavioural
Participants will receive usual care for women who have experienced psychological trauma.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive Trauma Recovery and Empowerment Model and usual care Receives: Behavioral: Trauma Recovery and Empowerment Model (TREM); Behavioral: Usual care |
| 2 | Active comparator | Participants will receive usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity
Measured: Measured at baseline and Months 6, 12, and 18
Secondary outcomes (4)
Distorted beliefs
Measured: Measured at baseline and Months 6, 12, and 18
Depressive symptoms
Measured: Measured at baseline and Months 6, 12, and 18
Substance use
Measured: Measured at baseline and Months 6, 12, and 18
Mental health service utilization
Measured: Measured at Months 6, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gregory J. McHugo, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183716
- Sponsor's protocol ID
- R01MH068252
- Other IDs
- R01MH068252, DSIR 83-ATAS
- Acronym
- TREM
- Status last verified
- Jul 2012
- First submitted
- 14 Sep 2005
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model
- ClinicalTrials.gov ID
- NCT00183716
- Acronym / sponsor ID
- TREM / R01MH068252
- Conditions
- Post-Traumatic Stress Disorder, Mental Disorders, Depression
- Keywords
- PTSD, Physical Abuse, Sexual Abuse, Women, Trauma, Group Therapy, Substance Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 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 determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse.
Detailed description
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. Rates of PTSD are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression, substance abuse, and poor overall health. In turn, these issues lead to high rates of utilization of mental health services. Unfortunately, there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings. Trauma Recovery and Empowerment Model (TREM) is a group-based intervention that addresses PTSD and other closely related consequences of sexual and physical abuse among women with severe mental disorders. This study will determine the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental disorders who have experienced sexual or physical abuse.
Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months. Usual care will include medication, case management, and therapy administered by a primary clinician. Participants assigned to usual care will report to the study site at least once a week, or as often as necessary. Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary. In addition, TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame. PTSD symptom severity, trauma beliefs, depressive symptoms, substance use, and mental health service utilization will be measured at Months 6, 12, and 18 for all participants.
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: Trauma Recovery and Empowerment Model (TREM), Behavioral: Usual careParticipants will receive Trauma Recovery and Empowerment Model and usual care |
| 2 | Active comparator | Behavioral: Usual careParticipants will receive usual care |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of physical and/or sexual abuse
- Diagnosis of a severe mental disorder
- Diagnosis of PTSD with a symptom severity score of 21 or higher
Key exclusion criteria (1 listed)
- Severe developmental disabilities or organic brain damage
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 |
|---|---|---|
| Trauma Recovery and Empowerment Model (TREM)TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment. | Behavioural | 1 |
| Usual careParticipants will receive usual care for women who have experienced psychological trauma. | Behavioural | 1, 2 |
Primary outcome
PTSD symptom severity
Time frame: Measured at baseline and Months 6, 12, and 18
4 secondary outcomes
Distorted beliefs
Time frame: Measured at baseline and Months 6, 12, and 18
Depressive symptoms
Time frame: Measured at baseline and Months 6, 12, and 18
Substance use
Time frame: Measured at baseline and Months 6, 12, and 18
Mental health service utilization
Time frame: Measured at Months 6, 12, and 18
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 23 Jul 2012.
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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.
Gregory J. McHugo, PhD principal investigator
Dartmouth College
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 Trauma Recovery and Empowerment Model (TREM) in people with Post-Traumatic Stress Disorder and Mental Disorders, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 1 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 23 Jul 2012. 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?
PTSD symptom severity (time frame: Measured at baseline and Months 6, 12, and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2012.