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Treatment of PTSD in Residents of Battered Women's Shelters

Treatment of PTSD in Residents of Battered Women's Shelters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398227
Acronym
HOPE
Enrollment
172
Registered
2015-03-25
Start date
2013-01-31
Completion date
2017-06-30
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

Battered Women, Trauma, Domestic Violence

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.

Interventions

BEHAVIORALHOPE

Cognitive Behavioral Treatment for PTSD in Battered Women

BEHAVIORALPCT

Present Centered Therapy for PTSD

Sponsors

Brown University
CollaboratorOTHER
Summa Health System
CollaboratorOTHER
Kent State University
CollaboratorOTHER
Pacific Institute for Research and Evaluation
CollaboratorOTHER
The University of Akron
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale (CAPS)baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatmentClinical 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
Severity of Violence Against Women Scale (SVAWS)baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatmentSeverity 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

Countries

United States

Participant flow

Participants by arm

ArmCount
HOPE
Cognitive Behavioral Treatment Program for PTSD HOPE: Cognitive Behavioral Treatment for PTSD in Battered Women
83
Present Centered Therapy (PCT)
Present Centered Therapy for PTSD PCT: Present Centered Therapy for PTSD
89
Total172

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2112
Overall StudyRemoved from treatment and dropped out10
Overall StudyWithdrawal by Subject56

Baseline characteristics

CharacteristicHOPEPresent Centered Therapy (PCT)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
83 Participants89 Participants172 Participants
Age, Continuous34.5 Years36 Years35.13 Years
Clinician-Administered PTSD Scale (CAPS)72.11 units on a scale
STANDARD_DEVIATION 20.87
77.82 units on a scale
STANDARD_DEVIATION 21.12
75.06 units on a scale
STANDARD_DEVIATION 21.14
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
80 Participants87 Participants167 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
33 Participants43 Participants76 Participants
Race (NIH/OMB)
More than one race
8 Participants7 Participants15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
41 Participants39 Participants80 Participants
Region of Enrollment
United States
83 participants89 participants172 participants
Sex: Female, Male
Female
83 Participants89 Participants172 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 830 / 89
other
Total, other adverse events
75 / 8376 / 89
serious
Total, serious adverse events
56 / 8356 / 89

Outcome results

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

Time frame: baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment

Population: Analysis include those participants who completed each follow-up time point.

ArmMeasureGroupValue (MEAN)Dispersion
HOPEClinician Administered PTSD Scale (CAPS)post-shelter48.08 units on a scaleStandard Deviation 25.36
HOPEClinician Administered PTSD Scale (CAPS)post-treatment31.75 units on a scaleStandard Deviation 22.47
HOPEClinician Administered PTSD Scale (CAPS)6 month post-treatment29.36 units on a scaleStandard Deviation 28.36
HOPEClinician Administered PTSD Scale (CAPS)1 year post-treatment27.32 units on a scaleStandard Deviation 24.96
Present Centered Therapy (PCT)Clinician Administered PTSD Scale (CAPS)1 year post-treatment29.00 units on a scaleStandard Deviation 28.03
Present Centered Therapy (PCT)Clinician Administered PTSD Scale (CAPS)post-shelter52.39 units on a scaleStandard Deviation 28.05
Present Centered Therapy (PCT)Clinician Administered PTSD Scale (CAPS)6 month post-treatment32.63 units on a scaleStandard Deviation 27.33
Present Centered Therapy (PCT)Clinician Administered PTSD Scale (CAPS)post-treatment34.43 units on a scaleStandard Deviation 28.33
p-value: 0.968ANCOVA
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

Time frame: baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment

Population: Analysis only include those who completed all time-points

ArmMeasureGroupValue (MEAN)Dispersion
HOPESeverity of Violence Against Women Scale (SVAWS)post-shelter7.81 score on a scaleStandard Deviation 15.37
HOPESeverity of Violence Against Women Scale (SVAWS)post-treatment3.47 score on a scaleStandard Deviation 8.82
HOPESeverity of Violence Against Women Scale (SVAWS)6-month post-shelter3.42 score on a scaleStandard Deviation 13.51
HOPESeverity of Violence Against Women Scale (SVAWS)1-year post-treatment2.40 score on a scaleStandard Deviation 9.03
Present Centered Therapy (PCT)Severity of Violence Against Women Scale (SVAWS)1-year post-treatment3.68 score on a scaleStandard Deviation 12.88
Present Centered Therapy (PCT)Severity of Violence Against Women Scale (SVAWS)post-shelter13.89 score on a scaleStandard Deviation 28.74
Present Centered Therapy (PCT)Severity of Violence Against Women Scale (SVAWS)6-month post-shelter2.73 score on a scaleStandard Deviation 8.55
Present Centered Therapy (PCT)Severity of Violence Against Women Scale (SVAWS)post-treatment1.10 score on a scaleStandard Deviation 3.86
p-value: 0.56ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026