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| Name | Class |
|---|---|
| Brown University | OTHER |
| Summa Health System | OTHER |
| Kent State University | OTHER |
| Pacific Institute for Research and Evaluation |
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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:
We will also explore the following hypotheses regarding potential mediators and moderators of HOPE:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOPE | Experimental | Cognitive Behavioral Treatment Program for PTSD |
|
| PCT | Active Comparator | Present Centered Therapy for PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOPE | Behavioral | Cognitive Behavioral Treatment for PTSD in Battered Women |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment |
| 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 | baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M Johnson, Ph.D. | The University of Akron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Akron | Akron | Ohio | 44325 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39869706 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HOPE | Cognitive Behavioral Treatment Program for PTSD HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women |
| FG001 | Present Centered Therapy (PCT) | Present Centered Therapy for PTSD PCT: Present Centered Therapy for PTSD |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HOPE | Cognitive Behavioral Treatment Program for PTSD HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women |
| BG001 | Present Centered Therapy (PCT) | Present Centered Therapy for PTSD PCT: Present Centered Therapy for PTSD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis include those participants who completed each follow-up time point. | Posted | Mean | Standard Deviation | units on a scale | baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment |
|
12-month follow-up.
12-month follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HOPE | Cognitive Behavioral Treatment Program for PTSD HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Life Threatening Experience or Trauma | Social circumstances | Serious, Other | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-life Threatening Abuse or Trauma | Social circumstances | Serious, Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn M Johnson, Ph.d | University of Akron | 3309722505 | johnsod@uakron.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 6, 2015 | Jun 19, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2011 | Aug 9, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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| PCT |
| Behavioral |
Present Centered Therapy for PTSD |
|
| Removed from treatment and dropped out |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 | Mean | Standard Deviation | units on a scale |
|
Present Centered Therapy for PTSD
PCT: Present Centered Therapy for PTSD
|
|
|
| Primary | 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 | Analysis only include those who completed all time-points | Posted | Mean | Standard Deviation | score on a scale | baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment |
|
|
|
|
| 0 |
| 83 |
| 56 |
| 83 |
| 75 |
| 83 |
| EG001 | Present Centered Therapy (PCT) | Present Centered Therapy for PTSD PCT: Present Centered Therapy for PTSD | 0 | 89 | 56 | 89 | 76 | 89 |
| Life Threatening Experience and Sexual Assault | Social circumstances | Serious, Other | Systematic Assessment |
|
| Significant Clinical Deterioration Suicidality | Psychiatric disorders | Serious, Other | Systematic Assessment |
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| Active Homicidality | Psychiatric disorders | Serious, Other | Systematic Assessment |
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| Psychiatric Inpatient Hospitalization | Psychiatric disorders | Serious, Other | Systematic Assessment |
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| Hospitalization Related to Domestic Violence | Social circumstances | Serious, Other | Systematic Assessment |
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| Other Hospitalization | Social circumstances | Serious, Other | Systematic Assessment |
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| Receipt of a Serious Health Diagnosis | Social circumstances | Serious, Other | Systematic Assessment |
|
| Sexual Assault | Social circumstances | Serious, Other | Systematic Assessment |
|
| Reporting to Children's Services | Social circumstances | Serious, Other | Systematic Assessment |
|
| Criminal Charge or Arrest | Social circumstances | Serious, Other | Systematic Assessment |
|
| Persistent or Significant Disability or Impairment | Social circumstances | Serious, Other | Systematic Assessment |
|
| Pregnancy Complications | Social circumstances | Serious, Other | Systematic Assessment |
|
| Substance Use | Psychiatric disorders | Serious, Other | Systematic Assessment |
|
| Significant Clinical Deterioration CAPS | Psychiatric disorders | Serious, Other | Systematic Assessment |
|
| Confidentiality Breach | Social circumstances | Serious, Other | Systematic Assessment |
|
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| 6-month post-shelter |
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| 1-year post-treatment |
|