Post-Traumatic Stress DisorderPhase 1NCT00602069
Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder
A Phase 1 study testing Helping to Overcome PTSD through Empowerment (HOPE) and Treatment as usual in people with Post-Traumatic Stress Disorder and Battered Women, run by The University of Akron at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder, Battered Women
- What is being tested?
- Helping to Overcome PTSD through Empowerment (HOPE) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for PTSD or subthreshold PTSD
- Resident of a battered women's shelter
- Abused in the month prior to study entry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of PTSD in Recently Battered Women Living in Shelters
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.
Read the detailed description
Intimate partner violence is a serious social problem with potentially severe mental health and functional consequences consistent with post-traumatic stress disorder (PTSD). Shelters provide an important resource for abused women in that they offer emergency shelter, support, and access to community resources that can aid in establishing long-term safety for women and their children. However, recent research suggests that symptoms of PTSD can compromise abused women's ability to access and effectively use these resources, emphasizing the importance of initiating treatment for PTSD. Despite the fact that on an annual basis 300,000 battered women and children access shelter services, virtually no research has investigated treatment of PTSD in sheltered abused women. A woman's entry into a shelter seems to be a prime time to begin any necessary psychological treatment. Helping to Overcome PTSD through Empowerment (HOPE), a brief cognitive behavioral treatment that emphasizes stabilization and empowerment of women, may help in treating abused women with PTSD. This study will evaluate the effectiveness of HOPE in treating abused women with PTSD who are in shelters.
Participation in this single-blind study will begin during a woman's shelter stay and will end 8 months after she completes the shelter treatment period. All potential participants will first undergo an initial interview, which will include questions about their abusive relationships, emotional difficulties, stressful events, and other previous treatments. Participants invited to continue with the study will be randomly assigned to the HOPE program or to shelter treatment as usual. Participants assigned to the HOPE program will participate in a maximum of 16 counseling sessions, with up to 10 of these sessions taking place while they are at the shelter. During these sessions, participants will learn skills to help manage emotional difficulties and ways to deal with their abusive relationships. Participants will attend two 60- to 90-minute sessions each week until they complete of the 10 shelter-based counseling sessions or depart from the shelter. Counseling sessions will continue at St. Thomas Hospital or other agreed-upon location twice per week during the first 8 weeks after departure from the shelter. All participants will repeat the initial interview and/or questionnaire at various times during and after the shelter stay, for a total of eight assessments. The final interview assessment will occur 6 months after participants complete the counseling sessions.
- Conditions
- Post-Traumatic Stress Disorder, Battered Women
- Being tested
- Helping to Overcome PTSD through Empowerment (HOPE), Treatment as usual
- Keywords
- PTSD, Intimate Partner Violence, Cognitive Behavioral Therapy, Empowerment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping to Overcome PTSD through Empowerment (HOPE)Behavioural
Also called HOPE
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.
Treatment as usualBehavioural
Treatment as usual includes standard shelter services for abused women.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program Receives: Behavioral: Helping to Overcome PTSD through Empowerment (HOPE) |
| 2 | Active comparator | Participants will receive standard shelter services Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity
Measured: Measured at Month 8
Secondary outcomes (5)
Effective use of resources
Measured: Measured at Month 8
Resource loss
Measured: Measured at Month 8
Depression
Measured: Measured at Month 8
Social functioning
Measured: Measured at Month 8
Revictimization
Measured: Measured at Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Akron
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Summa Health System, Butler Hospital
- Responsible party
- Sponsor
- Investigators
- Dawn M. Johnson, PhD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602069
- Sponsor's protocol ID
- R34MH080786
- Other IDs
- R34MH080786, DATR AD-TS
- Status last verified
- Jun 2013
- First submitted
- 18 Jan 2008
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16929512Johnson 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.
PubMed 27459503
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of PTSD in Recently Battered Women Living in Shelters
- ClinicalTrials.gov ID
- NCT00602069
- Acronym / sponsor ID
- R34MH080786
- Conditions
- Post-Traumatic Stress Disorder, Battered Women
- Keywords
- PTSD, Intimate Partner Violence, Cognitive Behavioral Therapy, Empowerment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of AkronUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Summa Health System, Butler Hospital
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intimate partner violence is a serious social problem with potentially severe mental health and functional consequences consistent with post-traumatic stress disorder (PTSD). Shelters provide an important resource for abused women in that they offer emergency shelter, support, and access to community resources that can aid in establishing long-term safety for women and their children. However, recent research suggests that symptoms of PTSD can compromise abused women's ability to access and effectively use these resources, emphasizing the importance of initiating treatment for PTSD. Despite the fact that on an annual basis 300,000 battered women and children access shelter services, virtually no research has investigated treatment of PTSD in sheltered abused women. A woman's entry into a shelter seems to be a prime time to begin any necessary psychological treatment. Helping to Overcome PTSD through Empowerment (HOPE), a brief cognitive behavioral treatment that emphasizes stabilization and empowerment of women, may help in treating abused women with PTSD. This study will evaluate the effectiveness of HOPE in treating abused women with PTSD who are in shelters.
Participation in this single-blind study will begin during a woman's shelter stay and will end 8 months after she completes the shelter treatment period. All potential participants will first undergo an initial interview, which will include questions about their abusive relationships, emotional difficulties, stressful events, and other previous treatments. Participants invited to continue with the study will be randomly assigned to the HOPE program or to shelter treatment as usual. Participants assigned to the HOPE program will participate in a maximum of 16 counseling sessions, with up to 10 of these sessions taking place while they are at the shelter. During these sessions, participants will learn skills to help manage emotional difficulties and ways to deal with their abusive relationships. Participants will attend two 60- to 90-minute sessions each week until they complete of the 10 shelter-based counseling sessions or depart from the shelter. Counseling sessions will continue at St. Thomas Hospital or other agreed-upon location twice per week during the first 8 weeks after departure from the shelter. All participants will repeat the initial interview and/or questionnaire at various times during and after the shelter stay, for a total of eight assessments. The final interview assessment will occur 6 months after participants complete the counseling sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Helping to Overcome PTSD through Empowerment (HOPE)Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program |
| 2 | Active comparator | Behavioral: Treatment as usualParticipants will receive standard shelter services |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets criteria for PTSD or subthreshold PTSD
- Resident of a battered women's shelter
- Abused in the month prior to study entry
Key exclusion criteria (6 listed)
- Significant suicidal ideation or risk
- Current psychotic symptoms
- Current alcohol or drug dependence
- Lifetime history of bipolar disorder
- Concurrent psychosocial treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helping to Overcome PTSD through Empowerment (HOPE)Also: HOPEHOPE 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. | Behavioural | 1 |
| Treatment as usualTreatment as usual includes standard shelter services for abused women. | Behavioural | 2 |
Primary outcome
PTSD symptom severity
Time frame: Measured at Month 8
5 secondary outcomes
Effective use of resources
Time frame: Measured at Month 8
Resource loss
Time frame: Measured at Month 8
Depression
Time frame: Measured at Month 8
Social functioning
Time frame: Measured at Month 8
Revictimization
Time frame: Measured at Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Background: PubMed 16929512Johnson 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.
- Derived from this study: PubMed 27459503Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M. Johnson, PhD principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Helping to Overcome PTSD through Empowerment (HOPE) and Treatment as usual in people with Post-Traumatic Stress Disorder and Battered Women, 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 6 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 24 Jun 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PTSD symptom severity (time frame: Measured at Month 8). 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 NCT00602069, which also lists 2 linked publications.
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 24 Jun 2013.