NCT01413984

Brief 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. 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:

  1. 1.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.
  2. 2.Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

August 3, 2011

Last Update Submit

March 17, 2014

Conditions

Keywords

Traumaincarcerationtreatmentsubstance abuse

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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)

    one week before treatment, one week post treatment

Study Arms (2)

cognitive behavioral group treatment

EXPERIMENTAL

Helping Women Recover/Beyond Trauma integrated substance abuse and trauma treatment group. (Dr. Covington)

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.

Interventions

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.

cognitive behavioral group treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or less remaining in prison
  • A Case Plan identifying substance abuse treatment need
  • Ability to read and comprehend
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eddie Warrior Correctional Facility

Taft, Oklahoma, 74463, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersWounds and InjuriesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Rachael Swopes, M.S.

    University of Tulsa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 10, 2011

Study Start

November 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations