Clinical trial NCT02398227: Treatment of PTSD in Residents of Battered Women's Shelters
Official title: Treatment of PTSD in Residents of Battered Women's Shelters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Battered Women
Trauma
Domestic Violence
Lead sponsor: The University of Akron
Sponsor class: OTHER
Collaborators: name: Brown University
name: Summa Health System
name: Kent State University
name: Pacific Institute for Research and Evaluation
First posted: 2015-03-25
Enrollment: 172
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study comparing a new treatment (HOPE) to supportive therapy in the treatment of PTSD in residents of battered women's shelters.

Detailed description: Research suggests that approximately 1 in 4 women report a history of intimate partner violence (IPV), and IPV is associated with severe psychological problems, especially PTSD. Battered women's shelters annually provide emergency shelter to approximately 300,000 women and children. A prime time to intervene with IPV victims might be when they enter shelter and have already initiated a change in their life. Standard shelter care typically includes case management to help women access resources that can assist them in establishing long-term safety for themselves and their children. However, PTSD symptoms may compromise victims' ability to effectively use integral community resources, as well as their ability to appropriately react to threat relevant information, interfering with their ability to establish safety for themselves and their children. As such, research has found PTSD to be associated with re-abuse in victims of IPV.

Despite the significant morbidity associated with IPV-related PTSD, our treatment, Helping to Overcome PTSD through Empowerment (HOPE), is the only extant treatment to date that has been developed to specifically target IPV-related PTSD in residents of battered women's shelters. Cognitive-behavioral treatments (CBT) for PTSD have been shown to be effective with multiple populations but do not address the unique needs of recent IPV victims. HOPE, a shelter-based, individual, brief CBT treatment for PTSD in victims of IPV, addresses IPV victims' current needs of safety, self-care, protection, and empowerment, as well as the exchange of information on PTSD symptoms and how these symptoms interfere with the use of shelter and community resources and their ability to establish safety. HOPE was specifically designed to serve as an evidence-based model program that could be implemented in a wide-range of shelter programs across the United States. The current proposal builds on the foundation of our NIMH-funded treatment development study (R34MH080786). Pilot work with HOPE supports the initial acceptability and feasibility of this new treatment. IPV victims who received a significant dose of HOPE were 12 times less likely than women received only standard shelter services to report being re-abused after leaving shelter. Further, women who received HOPE displayed fewer PTSD arousal and avoidance symptoms of PTSD, less depression, and greater social support and empowerment relative to women who did not receive HOPE. The overall aim of this project is to test the efficacy of HOPE relative to supportive therapy (i.e., Present Centered Therapy, PCT) in a sample of 186 female residents of battered women's shelters with IPV-related PTSD. In an effort to facilitate future dissemination of HOPE, sessions will be delivered by community therapists and the study will be conducted in a range of shelter systems. Furthermore, the current proposal, unlike the pilot study, will compare HOPE to an attention matched control condition, have a longer follow-up period, will assess the impact of HOPE on child abuse potential, and will incorporate objective measures of stress responding (e.g., attentional biases and physiological reactivity to trauma cues), explore mediators and moderators of treatment, and evaluate the cost effectiveness of HOPE.

The Specific Aim of this proposal is to conduct a randomized controlled trial comparing HOPE to PCT in residents of battered women shelters with IPV-related PTSD. The study will test the following hypotheses:

Primary Hypotheses: HOPE will be significantly more efficacious than PCT in reducing participants' IPV-related PTSD symptoms and severity of re-abuse over a one-year follow-up.

Secondary Hypotheses: Associated Symptoms, Psychosocial Functioning, and Cost:

* HOPE will be significantly more efficacious than PCT in decreasing participants' depressive symptoms and child abuse potential; in increasing participants' degree of empowerment, quality of life, degree and quality of social support, effective use of resources, and traumatic cognitions over a one-year follow-up.
* Shelter residents who receive HOPE will display reduced biases in attention to threat-related information and normalization of physiological reactivity to trauma cues, relative to women who receive PCT over a one-year follow-up.
* We also plan to evaluate the cost-effectiveness of HOPE measured by cost per quality adjusted life year saved (QULY).

We will also explore the following hypotheses regarding potential mediators and moderators of HOPE:

* The effect HOPE has on PTSD over the one-year follow-up will be mediated by participants' degree of empowerment, effective use of resources, and traumatic cognitions at post-treatment.
* HOPE participants' PTSD symptoms post-treatment will mediate participants' severity of re-abuse over the one-year follow-up period.
* We also plan to explore whether the following baseline variables are moderators of treatment response: minority status, IPV and PTSD severity, attentional biases to threat related information, and physiological reactivity to trauma cues.

HOPE, a novel treatment for battered women with IPV-related PTSD, has the potential to provide a national model of care for a vulnerable, underserved, and understudied population.

Eligibility criteria: Inclusion Criteria:

* must be resident in one of the 6 participating shelters,
* IPV in month prior to shelter,
* PTSD

Exclusion Criteria:

* substance dependence in last 3 months,
* change in meds in last month,
* Bipolar d/o,
* psychosis,
* active suicidality

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment
measure: Severity of Violence Against Women Scale (SVAWS)
timeFrame: baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: University of Akron
state: Ohio
Study officials:
affiliation: The University of Akron
name: Dawn M Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: