PTSD Clinical Trial
Official title:
Treatment of PTSD in Residents of Battered Women's Shelters
This is a study comparing a new treatment (HOPE) to supportive therapy in the treatment of PTSD in residents of battered women's shelters.
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.
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