NCT00602069

Brief Summary

This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

January 18, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

January 18, 2008

Last Update Submit

June 21, 2013

Conditions

Post-Traumatic Stress DisorderBattered Women

Keywords

PTSDIntimate Partner ViolenceCognitive Behavioral TherapyEmpowerment

Outcome Measures

Primary Outcomes (1)

  • PTSD symptom severity

    Measured at Month 8

Secondary Outcomes (5)

  • Effective use of resources

    Measured at Month 8

  • Resource loss

    Measured at Month 8

  • Depression

    Measured at Month 8

  • Social functioning

    Measured at Month 8

  • Revictimization

    Measured at Month 8

Study Arms (2)

1

EXPERIMENTAL

Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program

Behavioral: Helping to Overcome PTSD through Empowerment (HOPE)

2

ACTIVE COMPARATOR

Participants will receive standard shelter services

Behavioral: Treatment as usual

Interventions

Helping to Overcome PTSD through Empowerment (HOPE)BEHAVIORAL

HOPE includes a maximum of 16 sessions of cognitive behavioral therapy. The sessions will emphasize stabilization and empowerment, both of which are identified as important goals by the theoretical and empirical literature on abused women and PTSD.

Also known as: HOPE
1
Treatment as usualBEHAVIORAL

Treatment as usual includes standard shelter services for abused women.

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for PTSD or subthreshold PTSD
  • Resident of a battered women's shelter
  • Abused in the month prior to study entry

You may not qualify if:

  • Significant suicidal ideation or risk
  • Current psychotic symptoms
  • Current alcohol or drug dependence
  • Lifetime history of bipolar disorder
  • Concurrent psychosocial treatment
  • Any change in medication in the month prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Akron

Akron, Ohio, 44325, United States

Location

Related Publications (2)

  • Johnson DM, Zlotnick C. A cognitive-behavioral treatment for battered women with PTSD in shelters: findings from a pilot study. J Trauma Stress. 2006 Aug;19(4):559-64. doi: 10.1002/jts.20148.

    PMID: 16929512BACKGROUND

  • Johnson DM, Johnson NL, Perez SK, Palmieri PA, Zlotnick C. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial. J Trauma Stress. 2016 Aug;29(4):365-73. doi: 10.1002/jts.22117. Epub 2016 Jul 26.

    PMID: 27459503DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticEmpowerment

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Dawn M. Johnson, PhD

    Summa Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 28, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

US(1)