NCT02398227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4.5 years

First QC Date

May 28, 2013

Results QC Date

June 19, 2018

Last Update Submit

August 9, 2018

Conditions

Keywords

Battered WomenTraumaDomestic Violence

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

HOPE

EXPERIMENTAL

Cognitive Behavioral Treatment Program for PTSD

Behavioral: HOPE

PCT

ACTIVE COMPARATOR

Present Centered Therapy for PTSD

Behavioral: PCT

Interventions

HOPEBEHAVIORAL

Cognitive Behavioral Treatment for PTSD in Battered Women

HOPE
PCTBEHAVIORAL

Present Centered Therapy for PTSD

PCT

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Akron

Akron, Ohio, 44325, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Dawn M Johnson, Ph.d
Organization
University of Akron

Study Officials

  • Dawn M Johnson, Ph.D.

    The University of Akron

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2013

First Posted

March 25, 2015

Study Start

January 1, 2013

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

August 10, 2018

Results First Posted

August 10, 2018

Record last verified: 2018-08

Locations