Substance AbuseNCT01413984
Substance Abuse and Trauma in Incarcerated Women
A study testing Helping Women Recover/Beyond Trauma in people with Substance Abuse and Trauma, run by University of Tulsa at 1 site in United States.
Trial summary
The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Abuse, Trauma, Post Traumatic Stress Disorder
- What is being tested?
- Helping Women Recover/Beyond Trauma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incarcerated women at Eddie Warrior Correctional Center (EWCC) in Taft, Oklahoma
- The following 6 criteria are then employed at EWCC for HWR/BT treatment eligibility:
- An Level of Service Inventory (LSI) score of 30 or greater
- An LSI protective score of 15 or less
- 1.5 years or less remaining in prison
- A Case Plan identifying substance abuse treatment need
- Ability to read and comprehend
- 18 years of age or older
Who cannot join
- Under age 18
- Not incarcerated
- More than 1.5 years remaining in prison
- LSI score less than 30 or a protective of more than 15
- No identified substance abuse need
- Inability to read and comprehend
Trial locations and contacts
1 site in 1 country.
United States1 site
Eddie Warrior Correctional Facility
Taft, Oklahoma, 74463
About this study
Official title: Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study
The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below:
- Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group.
- Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.
- Conditions
- Substance Abuse, Trauma, Post Traumatic Stress Disorder, Integrated Treatment, Incarcerated Women
- Being tested
- Helping Women Recover/Beyond Trauma
- Keywords
- Trauma, incarceration, treatment, substance abuse
- Medical subject headings
- Substance-Related Disorders, Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping Women Recover/Beyond TraumaBehavioural
Four treatment rounds will be conducted, and a goal of 20 women (10 from each group) will be recruited to participate in each round. A new treatment group will start every four months. Sessions are approximately 2 hours each, 3-4 times per week over four months in a group format. This treatment program will focus on the integrated treatment of trauma and substance abuse in women. Versions of the curriculum exist both for community and corrections populations. In this intervention the corrections version will be used.
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral group treatment | Experimental | Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington) Receives: Behavioral: Helping Women Recover/Beyond Trauma |
| comparison group | No intervention | a comparison group of incarcerated women will receive the pre and post assessments with no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD checklist (change from baseline at one week post treatment)
17 item post traumatic stress disorder symptoms checklist will be administered pre treatment and one week following 4 month treatment completion.
Measured: one-week before treatment, one week post treatment
Trauma Related Nightmare Survey (change from baseline at one week post treatment)
brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
Posttraumatic Cognitions Inventory (change from baseline at one week post treatment)
36 item assesment of cognitions related to world, self and blame to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
CES-D, NIMH (change from baseline at one week post treatment)
Center for Epidemiologic Studies Depression Scale (CES-D), NIMH is a 20 item depression inventory to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
Drug-Taking Confidence Questionnaire (change from baseline at one week post treatment)
50 item assessment of alcohol and drugs self efficacy to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
Trauma Symptoms Inventory (change from baseline at one week post treatment)
100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
Secondary outcomes (1)
Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment)
two scales from the PSI and selected parenting issues from incarcerated women to be administered pre-treatment and one week following 4 month treatment completion.
Measured: one week before treatment, one week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tulsa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Swopes, University of Tulsa
- Investigators
- Rachael Swopes, M.S., Principal investigator, University of Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413984
- Sponsor's protocol ID
- TU 11-18
- Status last verified
- Mar 2014
- First submitted
- 3 Aug 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Abuse and Trauma in Incarcerated Women: An Effectiveness Study
- ClinicalTrials.gov ID
- NCT01413984
- Acronym / sponsor ID
- TU 11-18
- Conditions
- Substance Abuse, Trauma, Post Traumatic Stress Disorder, Integrated Treatment, Incarcerated Women
- Keywords
- Trauma, incarceration, treatment, substance abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of TulsaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Aug 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 proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below:
- Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group.
- Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral group treatment | Experimental | Behavioral: Helping Women Recover/Beyond TraumaHelping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington) |
| comparison group | No intervention | –a comparison group of incarcerated women will receive the pre and post assessments with no interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Incarcerated women at Eddie Warrior Correctional Center (EWCC) in Taft, Oklahoma
- The following 6 criteria are then employed at EWCC for HWR/BT treatment eligibility:
Key exclusion criteria (6 listed)
- Under age 18
- Not incarcerated
- More than 1.5 years remaining in prison
- LSI score less than 30 or a protective of more than 15
- No identified substance abuse need
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 |
|---|---|---|
| Helping Women Recover/Beyond TraumaFour treatment rounds will be conducted, and a goal of 20 women (10 from each group) will be recruited to participate in each round. A new treatment group will start every four months. Sessions are approximately 2 hours each, 3-4 times per week over four months in a group format. This treatment program will focus on the integrated treatment of trauma and substance abuse in women. Versions of the curriculum exist both for community and corrections populations. In this intervention the corrections version will be used. | Behavioural | cognitive behavioral group treatment |
Primary outcome
PTSD checklist (change from baseline at one week post treatment)
Time frame: one-week before treatment, one week post treatment
17 item post traumatic stress disorder symptoms checklist will be administered pre treatment and one week following 4 month treatment completion.
Trauma Related Nightmare Survey (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
brief assessment of nightmare frequency and severity to be administered pre-treatment and one week following 4 month treatment completion.
Posttraumatic Cognitions Inventory (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
36 item assesment of cognitions related to world, self and blame to be administered pre-treatment and one week following 4 month treatment completion.
CES-D, NIMH (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
Center for Epidemiologic Studies Depression Scale (CES-D), NIMH is a 20 item depression inventory to be administered pre-treatment and one week following 4 month treatment completion.
Drug-Taking Confidence Questionnaire (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
50 item assessment of alcohol and drugs self efficacy to be administered pre-treatment and one week following 4 month treatment completion.
Trauma Symptoms Inventory (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
100 item trauma symptoms questionnaire to be administered pre-treatment and one week following 4 month treatment completion.
1 secondary outcome
Parenting Stress Index for Incarcerated Women (change from baseline at one week post treatment)
Time frame: one week before treatment, one week post treatment
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 Mar 2014.
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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.
Rachael Swopes, M.S. principal investigator
University of Tulsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helping Women Recover/Beyond Trauma in people with Substance Abuse and Trauma, run by University of Tulsa 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 8 inclusion and 6 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 Mar 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.
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 checklist (change from baseline at one week post treatment) (time frame: one-week before treatment, one week post treatment). The study lists 6 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 18 Mar 2014.