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PTSDHOPENCT02398227

Treatment of PTSD in Residents of Battered Women's Shelters

A study testing HOPE and PCT in people with PTSD, run by The University of Akron at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
PTSD
What is being tested?
HOPE and PCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
Jan 2013to 30 Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Akron

    Akron, Ohio, 44325

Other trials in United States

About this study

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

Read the 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.

Conditions
PTSD
Being tested
HOPE, PCT
Keywords
Battered Women, Trauma, Domestic Violence
Medical subject headings
Stress Disorders, Post-Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOPEBehavioural

    Cognitive Behavioral Treatment for PTSD in Battered Women

  • PCTBehavioural

    Present Centered Therapy for PTSD

Study groups in NCT02398227
Study groupRoleWhat they receive
HOPEExperimentalCognitive Behavioral Treatment Program for PTSD
Receives: Behavioral: HOPE
PCTActive comparatorPresent Centered Therapy for PTSD
Receives: Behavioral: PCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician Administered PTSD Scale (CAPS)

    Clinical Interview assessing symptoms of Posttraumatic Stress Disorder (PTSD) scores can range from 0 to 136 with higher scores reflecting greater PTSD severity Adjusted means with baseline scores as a covariate are reported

    Measured: baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment

  2. Severity of Violence Against Women Scale (SVAWS)

    Severity of Violence Against Women Scale total score. Scores can range from 0 to 138 with higher scores reflecting greater degree of violence/abuse.Adjusted means with baseline scores as a covariate are reported

    Measured: baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startJan 2013
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02398227
Sponsor's protocol ID
1R01MH095767
Acronym
HOPE
Status last verified
Aug 2018
First submitted
28 May 2013
Last updated
10 Aug 2018
Data monitoring committee
Yes

Publications

  • Gonzalez A, Haws JK, Alshabani N, Zlotnick C, Johnson DM. Cyber abuse and posttraumatic stress disorder among racially diverse women who have resided in domestic violence shelters: A longitudinal approach. Psychol Trauma. 2025 Jun;17(Suppl 1):S105-S114. doi: 10.1037/tra0001868. Epub 2025 Jan 27.

    PubMed 39869706

Questions about this trial

What is this clinical trial studying?

A study testing HOPE and PCT in people with PTSD, run by The University of Akron 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 3 inclusion and 5 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 10 Aug 2018. 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?

Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinician Administered PTSD Scale (CAPS) (time frame: baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment). 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?

On the ClinicalTrials.gov record for NCT02398227, which also lists 1 linked publication.

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 10 Aug 2018.

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