PTSDPhase 2NCT00607412
Alcohol Use Disorders (AUDs) and Post-traumatic Stress Disorder (PTSD) Treatment for Victims of Partner Violence
A Phase 2 study testing Integrated psychotherapy for PTSD and substance use and 12-step based supportive therapy in people with PTSD and Substance Use Disorders, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PTSD, Substance Use Disorders
- What is being tested?
- Integrated psychotherapy for PTSD and substance use and 12-step based supportive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2011
- Phase
- Phase 2
- 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
- female victims of partner violence
- at least one month out of the abusive relationship
- meet DSM-IV (American Psychiatric Association, 1994) criteria for PTSD and an alcohol use disorder
- literate in English
- have not changed psychotropic medications or dosages within the past two months and agree not to during the active phase (first 12 weeks) of the intervention
- have an identified primary care physician
Who cannot join
- moderate or severe cognitive impairment as measured by a Mini-Mental State Examination score less than or equal to 18
- Histories of psychosis or mania may be excluded because the presence of these disorders is thought to impede progress in psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Outpatient Psychiatry
San Diego, California, 92103
About this study
Official title: AUDs and PTSD Treatment for Victims of Partner Violence
The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.
Read the detailed description
The goal of this study is to evaluate an integrated psychotherapy for PTSD and substance use disorders among female victims of intimate partner violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use post-treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.
- Conditions
- PTSD, Substance Use Disorders
- Being tested
- Integrated psychotherapy for PTSD and substance use, 12-step based supportive therapy
- Keywords
- PTSD, substance use disorders, psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated psychotherapy for PTSD and substance useBehavioural
integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence
12-step based supportive therapyBehavioural
supportive psychotherapy based on 12-step model
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Present focused, integrated psychotherapy for PTSD and substance use disorders Receives: Behavioral: Integrated psychotherapy for PTSD and substance use |
| 2 | Active comparator | Supportive therapy using 12-step model Receives: Behavioral: 12-step based supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS for PTSD symptoms and ASI for substance use
Measured: pre, mid treatment, post, 3-month follow-up, 6-month follow-up
Secondary outcomes (1)
Timeline Follow-back procedure, Beck Depression Inventory
Measured: same as primary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startAug 2007
- 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 PTSDStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Sonya Norman, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607412
- Sponsor's protocol ID
- K23AA015707
- Other IDs
- K23AA015707
- Status last verified
- Jun 2009
- First submitted
- 26 Dec 2007
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
PubMed 32608505Myers US, Browne KC, Norman SB. Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. J Dual Diagn. 2015;11(3-4):238-47. doi: 10.1080/15504263.2015.1113762.
PubMed 26515712
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUDs and PTSD Treatment for Victims of Partner Violence
- ClinicalTrials.gov ID
- NCT00607412
- Acronym / sponsor ID
- K23AA015707
- Conditions
- PTSD, Substance Use Disorders
- Keywords
- PTSD, substance use disorders, psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Feb 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.
The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.
Detailed description
The goal of this study is to evaluate an integrated psychotherapy for PTSD and substance use disorders among female victims of intimate partner violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use post-treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Integrated psychotherapy for PTSD and substance usePresent focused, integrated psychotherapy for PTSD and substance use disorders |
| 2 | Active comparator | Behavioral: 12-step based supportive therapySupportive therapy using 12-step model |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female victims of partner violence
- at least one month out of the abusive relationship
- meet DSM-IV (American Psychiatric Association, 1994) criteria for PTSD and an alcohol use disorder
- literate in English
- have not changed psychotropic medications or dosages within the past two months and agree not to during the active phase (first 12 weeks) of the intervention
Key exclusion criteria (2 listed)
- moderate or severe cognitive impairment as measured by a Mini-Mental State Examination score less than or equal to 18
- Histories of psychosis or mania may be excluded because the presence of these disorders is thought to impede progress in psychotherapy
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 |
|---|---|---|
| Integrated psychotherapy for PTSD and substance useintegrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence | Behavioural | 1 |
| 12-step based supportive therapysupportive psychotherapy based on 12-step model | Behavioural | 2 |
Primary outcome
CAPS for PTSD symptoms and ASI for substance use
Time frame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up
1 secondary outcome
Timeline Follow-back procedure, Beck Depression Inventory
Time frame: same as primary
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 11 May 2011.
- Derived from this study: PubMed 32608505Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
- Derived from this study: PubMed 26515712Myers US, Browne KC, Norman SB. Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. J Dual Diagn. 2015;11(3-4):238-47. doi: 10.1080/15504263.2015.1113762.
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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.
Sonya Norman principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Integrated psychotherapy for PTSD and substance use and 12-step based supportive therapy in people with PTSD and Substance Use Disorders, run by University of California, San Diego 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 6 inclusion and 2 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 11 May 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
CAPS for PTSD symptoms and ASI for substance use (time frame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up). 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 NCT00607412, 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 11 May 2011.