Posttraumatic Stress DisordersNCT00131534
The Trauma Recovery and Resiliency Research Project
An observational study of Posttraumatic Stress Disorders, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
The overall purpose of this study is the assessment of treatment outcome among traumatized patients seeking individual and/or group therapy at the Victims of Violence Program. The study gathers information from patients using quantitative (self-report) and qualitative (interview-based) approaches, to determine changes… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Individual therapy and Group therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 969 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1991to Jan 2012
- Phase
- Observational
- 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
Study population: Trauma survivors receiving outpatient treatment.
Who may be able to join
- In individual or group therapy at VOV program
- Consents to research participation
Who cannot join
- Insufficient proficiency in English to complete self-report measures and/or interview
- Research participation clinically counterindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Victims of Violence Program, Cambridge Health Alliance
Somerville, Massachusetts, 02143
About this study
The overall purpose of this study is the assessment of treatment outcome among traumatized patients seeking individual and/or group therapy at the Victims of Violence Program. The study gathers information from patients using quantitative (self-report) and qualitative (interview-based) approaches, to determine changes in symptom patterns and domains of functioning relevant to psychological trauma.
Read the detailed description
The focus of the Trauma Recovery and Resiliency Project is primarily the evaluation of treatment outcome among complexly traumatized patients seeking individual and/or group therapy at the Victims of Violence (VOV) Program, a specialty clinic located in the Outpatient Psychiatry Department of the Cambridge Health Alliance and affiliated with Harvard Medical School. The project has two major components: (1) All patients seeking VOV treatment are administered a battery of self-report measures assessing symptoms associated with complex trauma (i.e., interpersonal trauma that is usually repeated and prolonged) (2) A subsample of patients are interviewed using the Multidimensional Trauma Recovery and Resiliency Interview (MTRRI) and its companion rating scale (MTRR; Harvey et al, 1994, 2000, 2003) to assess trauma impact, recovery and resiliency on eight domains of psychological functioning. Data is analyzed using quantitative and qualitative approaches to evaluate treatment effectiveness and elucidate the recovery trajectories of patients receiving VOV treatment. Two subprojects include (a) preparation of a treatment manual documenting the Women's Trauma Recovery Group, and (b) pilot testing a new interview-based measure of complex trauma symptoms, the Symptoms of Trauma Scale (SOTS).
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Individual therapy, Group therapy
- Keywords
- Complex trauma, Trauma recovery, Resiliency, Posttraumatic stress, Individual psychotherapy, Group psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual therapyBehavioural
Stage-based individual therapy for trauma survivors
Group therapyBehavioural
Stage-based group therapy for trauma survivors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startAug 1991
- Primary completionFeb 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary R. Harvey, Ph.D., Principal investigator, Victims of Violence Program, Cambridge Health AllianceJudith L. Herman, MD, Principal investigator, Victims of Violence Program, Cambridge Health AllianceMichaela Mendelsohn, Ph.D., Principal investigator, Victims of Violence Program, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131534
- Sponsor's protocol ID
- CHA-IRB-0031/01/04
- Status last verified
- Apr 2017
- First submitted
- 16 Aug 2005
- Last updated
- 18 Apr 2017
- Results posted
- No
Publications
Harney PA, Harvey MR. Group psychotherapy: An overview. In BH Young & DD Blake (Eds.), Group treatments for post-traumatic stress disorder (pp. 1-13). New York, NY: Brunner/Mazel, 1999.
Harvey MR. An ecological view of psychological trauma and trauma recovery. J Trauma Stress. 1996 Jan;9(1):3-23.
PubMed 8750448Harvey MR, Harney PA. Individual psychotherapy. In C Classen & ID Yalom (Eds.), Treating women molested in childhood (pp. 63-91). San Francisco, CA: Jossey-Bass Publishers, 1995.
Harvey MR, Liang B, Harney PA, Koenen K, Tummala-Narra P, Lebowitz L. A multidimensional approach to the assessment of trauma impact, recovery and resiliency: Initial psychometric findings. Journal of Aggression, Maltreatment and Trauma, 6: 87-109, 2003.
Harvey MR, Mishler EG, Koenen K, Harney PA. In the aftermath of sexual abuse: Making and remaking meaning in narratives of trauma and recovery. Narrative Inquiry, 10: 291-311, 2000.
Harvey MR, Weston D. Multidimensional trauma recovery and resiliency measures: The MTRRI (Interview) and the MTRRQ (Sort). In BH Stamm (Ed.), Measurement of stress, trauma, and adaptation (pp. 209-211). Lutherville, MD: The Sidran Press, 1996.
Herman, JL. Complex PTSD: A syndrome in survivors of prolonged and repeated trauma. Journal of Traumatic Stress, 3: 377-391, 1992.
Herman JL. Trauma and recovery. New York: Basic Books, 1992.
Mendelsohn M, Zachary R, Harney P. Group therapy as an ecological bridge to a new community. Special issue of Journal of Aggression, Maltreatment and Trauma, 14, 227-243.
Forman EM, Lynch SM, Bryant TS, Herman JL. Using effectiveness and patient-focused data to evaluate outcome of a community-based trauma treatment. Paper presented at the 17th Annual Meeting of the International Society for Traumatic Stress Studies, New Orleans, LA, 2001.
Mendelsohn M, Forman EM, Lynch SM, Herman JL. Group therapy at the Victims of Violence Program: Preliminary Findings. Paper presented at 20th Annual Meeting of the International Society for Traumatic Stress Studies; New Orleans, LA, 2004.
Lynch S, Forman E, Mendelsohn M, Herman, JL. A comparison of high and low dissociators' response to trauma-focused treatment. Paper presented at the 21st Conference of the International Society for the Study of Dissociation; New Orleans, LA; 2004.
Lynch SM, Forman E, Mendelsohn M, Herman J. Attending to dissociation: assessing change in dissociation and predicting treatment outcome. J Trauma Dissociation. 2008;9(3):301-19. doi: 10.1080/15299730802139063.
PubMed 19042780Dutra L, Callahan K, Forman E, Mendelsohn M, Herman J. Core schemas and suicidality in a chronically traumatized population. J Nerv Ment Dis. 2008 Jan;196(1):71-4. doi: 10.1097/NMD.0b013e31815fa4c1.
PubMed 18195645Lynch SM, Keasler AL, Reaves, RC, Channer EG, Bukowski LT. The Story of My Strength: An Exploration of Resilience in the Narratives of Trauma Survivors Early in Recovery. Journal of Aggression, Maltreatment & Trauma 14: 75-97, 2007 Publisher: Haworth Press
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trauma Recovery and Resiliency Research Project
- ClinicalTrials.gov ID
- NCT00131534
- Acronym / sponsor ID
- CHA-IRB-0031/01/04
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- Complex trauma, Trauma recovery, Resiliency, Posttraumatic stress, Individual psychotherapy, Group psychotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 969 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- Aug 1991
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Aug 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.
The overall purpose of this study is the assessment of treatment outcome among traumatized patients seeking individual and/or group therapy at the Victims of Violence Program. The study gathers information from patients using quantitative (self-report) and qualitative (interview-based) approaches, to determine changes in symptom patterns and domains of functioning relevant to psychological trauma.
Detailed description
The focus of the Trauma Recovery and Resiliency Project is primarily the evaluation of treatment outcome among complexly traumatized patients seeking individual and/or group therapy at the Victims of Violence (VOV) Program, a specialty clinic located in the Outpatient Psychiatry Department of the Cambridge Health Alliance and affiliated with Harvard Medical School. The project has two major components: (1) All patients seeking VOV treatment are administered a battery of self-report measures assessing symptoms associated with complex trauma (i.e., interpersonal trauma that is usually repeated and prolonged) (2) A subsample of patients are interviewed using the Multidimensional Trauma Recovery and Resiliency Interview (MTRRI) and its companion rating scale (MTRR; Harvey et al, 1994, 2000, 2003) to assess trauma impact, recovery and resiliency on eight domains of psychological functioning. Data is analyzed using quantitative and qualitative approaches to evaluate treatment effectiveness and elucidate the recovery trajectories of patients receiving VOV treatment. Two subprojects include (a) preparation of a treatment manual documenting the Women's Trauma Recovery Group, and (b) pilot testing a new interview-based measure of complex trauma symptoms, the Symptoms of Trauma Scale (SOTS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma survivors receiving outpatient treatment.
Key inclusion criteria (2 listed)
- In individual or group therapy at VOV program
- Consents to research participation
Key exclusion criteria (2 listed)
- Insufficient proficiency in English to complete self-report measures and/or interview
- Research participation clinically counterindicated
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 |
|---|---|---|
| Individual therapyStage-based individual therapy for trauma survivors | Behavioural | – |
| Group therapyStage-based group therapy for trauma survivors | 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 18 Apr 2017.
- BackgroundHarney PA, Harvey MR. Group psychotherapy: An overview. In BH Young & DD Blake (Eds.), Group treatments for post-traumatic stress disorder (pp. 1-13). New York, NY: Brunner/Mazel, 1999.
- Background: PubMed 8750448Harvey MR. An ecological view of psychological trauma and trauma recovery. J Trauma Stress. 1996 Jan;9(1):3-23.
- BackgroundHarvey MR, Harney PA. Individual psychotherapy. In C Classen & ID Yalom (Eds.), Treating women molested in childhood (pp. 63-91). San Francisco, CA: Jossey-Bass Publishers, 1995.
- BackgroundHarvey MR, Liang B, Harney PA, Koenen K, Tummala-Narra P, Lebowitz L. A multidimensional approach to the assessment of trauma impact, recovery and resiliency: Initial psychometric findings. Journal of Aggression, Maltreatment and Trauma, 6: 87-109, 2003.
- BackgroundHarvey MR, Mishler EG, Koenen K, Harney PA. In the aftermath of sexual abuse: Making and remaking meaning in narratives of trauma and recovery. Narrative Inquiry, 10: 291-311, 2000.
- BackgroundHarvey MR, Weston D. Multidimensional trauma recovery and resiliency measures: The MTRRI (Interview) and the MTRRQ (Sort). In BH Stamm (Ed.), Measurement of stress, trauma, and adaptation (pp. 209-211). Lutherville, MD: The Sidran Press, 1996.
- BackgroundHerman, JL. Complex PTSD: A syndrome in survivors of prolonged and repeated trauma. Journal of Traumatic Stress, 3: 377-391, 1992.
- BackgroundHerman JL. Trauma and recovery. New York: Basic Books, 1992.
- BackgroundMendelsohn M, Zachary R, Harney P. Group therapy as an ecological bridge to a new community. Special issue of Journal of Aggression, Maltreatment and Trauma, 14, 227-243.
- Results publicationForman EM, Lynch SM, Bryant TS, Herman JL. Using effectiveness and patient-focused data to evaluate outcome of a community-based trauma treatment. Paper presented at the 17th Annual Meeting of the International Society for Traumatic Stress Studies, New Orleans, LA, 2001.
- Results publicationMendelsohn M, Forman EM, Lynch SM, Herman JL. Group therapy at the Victims of Violence Program: Preliminary Findings. Paper presented at 20th Annual Meeting of the International Society for Traumatic Stress Studies; New Orleans, LA, 2004.
- Results publicationLynch S, Forman E, Mendelsohn M, Herman, JL. A comparison of high and low dissociators' response to trauma-focused treatment. Paper presented at the 21st Conference of the International Society for the Study of Dissociation; New Orleans, LA; 2004.
Related trials for Posttraumatic Stress Disorders
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Mary R. Harvey, Ph.D. principal investigator
Victims of Violence Program, Cambridge Health Alliance
Judith L. Herman, MD principal investigator
Victims of Violence Program, Cambridge Health Alliance
Michaela Mendelsohn, Ph.D. principal investigator
Victims of Violence Program, Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorders, run by Cambridge Health Alliance 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 2 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 18 Apr 2017. 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 NCT00131534, which also lists 15 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 18 Apr 2017.