Posttraumatic Stress DisorderPhase 2/3WOMANNCT01324765
Women Overcoming and Managing Adversity Now (WOMAN) Study
A Phase 2/3 study testing TARGET and SGT in people with Posttraumatic Stress Disorder and PTSD, run by UConn Health at 1 site in United States.
Trial summary
The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, PTSD
- What is being tested?
- TARGET and SGT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incarcerated, release not expected within 6 months
- Probable PTSD on PC-PTSD screen and PTSD by CAPS interview
Who cannot join
- Clinically significant psychopathy (PCL-SV severe range)
- Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).
Trial locations and contacts
1 site in 1 country.
United States1 site
York Correctional Institution
Niantic, Connecticut, 06357
About this study
The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).
Read the detailed description
In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Being tested
- TARGET, SGT
- Keywords
- Women, PTSD, Group Therapy, Incarceration
- 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.
TARGETBehavioural
12-session group therapy twice weekly 6 weeks
SGTBehavioural
12 sessions supportive group therapy twice weekly 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| TARGET | Experimental | 12-session affect regulation therapy for PTSD Receives: Behavioral: TARGET |
| SGT | Active comparator | 12 session supportive group therapy Receives: Behavioral: SGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
PTSD symptom severity, Clinician Administered PTSD Scale
Measured: Post-therapy (within 2 weeks)
PTSD
PTSD symptom severity, Clinician Administered PTSD Scale
Measured: 3-4 Month Post-therapy Follow-up
Secondary outcomes (6)
Emotion Regulation
Negative Mood Regulation Scale
Measured: Post-therapy (within 2 weeks)
Trauma-related symptoms
Trauma Symptom Inventory (TSI; Briere, 1995). The TSI is a reliable and validated 100-item measure that generates composite scores for trauma (PTSD symptoms), self (self-regulation problems), and dysphoria (depression, anxiety, anger symptoms).
Measured: Post-therapy (within 2 weeks)
Mental health symptoms, well-being, and self-harm
CORE-OM is a 34-item self-report measure reliably and validly assessing current psychiatric symptom severity, risk of harm to self or others, social functioning, and subjective well being
Measured: Post-therapy (within 2 weeks)
Emotion Regulation
Negative Mood Regulation Scale
Measured: 3-4 Month Post-therapy Follow-up
Trauma-related Symptoms
Trauma Symptom Inventory
Measured: 3-4 Month Post-therapy Follow-up
Mental health symptoms, well-being, and self-harm
CORE-OM 34-item questionnaire
Measured: 3-4 Month Post-therapy Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Investigators
- Julian D Ford, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324765
- Sponsor's protocol ID
- 09009-2
- Other IDs
- 2009-DD-BX-0003
- Acronym
- WOMAN
- Status last verified
- Mar 2011
- First submitted
- 23 Sep 2010
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Overcoming and Managing Adversity Now (WOMAN) Study
- ClinicalTrials.gov ID
- NCT01324765
- Acronym / sponsor ID
- WOMAN / 09009-2
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Keywords
- Women, PTSD, Group Therapy, Incarceration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Mar 2011 (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 goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).
Detailed description
In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARGET | Experimental | Behavioral: TARGET12-session affect regulation therapy for PTSD |
| SGT | Active comparator | Behavioral: SGT12 session supportive group therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Incarcerated, release not expected within 6 months
- Probable PTSD on PC-PTSD screen and PTSD by CAPS interview
Key exclusion criteria (2 listed)
- Clinically significant psychopathy (PCL-SV severe range)
- Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).
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 |
|---|---|---|
| TARGET12-session group therapy twice weekly 6 weeks | Behavioural | TARGET |
| SGT12 sessions supportive group therapy twice weekly 6 weeks | Behavioural | SGT |
Primary outcome
PTSD
Time frame: Post-therapy (within 2 weeks)
PTSD symptom severity, Clinician Administered PTSD Scale
PTSD
Time frame: 3-4 Month Post-therapy Follow-up
PTSD symptom severity, Clinician Administered PTSD Scale
6 secondary outcomes
Emotion Regulation
Time frame: Post-therapy (within 2 weeks)
Trauma-related symptoms
Time frame: Post-therapy (within 2 weeks)
Mental health symptoms, well-being, and self-harm
Time frame: Post-therapy (within 2 weeks)
Emotion Regulation
Time frame: 3-4 Month Post-therapy Follow-up
Trauma-related Symptoms
Time frame: 3-4 Month Post-therapy Follow-up
Mental health symptoms, well-being, and self-harm
Time frame: 3-4 Month Post-therapy Follow-up
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 29 Mar 2011.
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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.
Julian D Ford, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TARGET and SGT in people with Posttraumatic Stress Disorder and PTSD, run by UConn Health 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 29 Mar 2011. 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 combined 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.
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 (time frame: Post-therapy (within 2 weeks)). The study lists 2 primary outcomes in all. 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 29 Mar 2011.