PTSDCCCVNCT01627548
UCLA Couples Counseling for Combat Veterans
A study testing Structured Approach Therapy in people with PTSD and Recent Era Combat Veteran, run by University of California, Los Angeles at 1 site in United States.
Trial summary
A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Recent Era Combat Veteran, Couples Communication
- What is being tested?
- Structured Approach Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2013
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OIF/OEF/ OND veteran with at least one deployment
- In a cohabitating relationship for 6 months or longer
- Cohabitating 50% of the time or more
- Diagnosed with PTSD or meets the diagnosis criteria for PTSD as related to deployment experience (CAPS)
- Ability to make weekly appointments
- Willingness to commit to change
Who cannot join
- Receiving an evidence-based treatment for PTSD within the past 6 months
- Receiving couples therapy within the last 6 months
- Moderate or excessive physical violence within the past 3 months (CTS)
- Alcohol/substance dependence (SCID)
- Known domestic violence/abuse (CTS)
- Symptoms of psychosis within the past 3 months
- Unstable psychiatric medicine usage or on regimen less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UCLA Welcome Back Veterans Family Resilience Center Couples Counseling for Combat Veterans
A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.
- Conditions
- PTSD, Recent Era Combat Veteran, Couples Communication
- Being tested
- Structured Approach Therapy
- Keywords
- PTSD, Couples, Combat Veteran, Warfighter, OEF, OIF, OND, Structured Approach Therapy, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Approach TherapyBehavioural
The SAT treatment is provided in 12 weekly 50-minute sessions and is fully manualized. First, couple-based exposure techniques are used to address anxiety about intimacy, increasing the traumatized person's ability to engage in social and relational behaviors that promote bonding and satisfaction. Second, as anxiety decreases, couple-based techniques are also used to increase the positive experiences the couple is having. These activities expose the traumatized person to positive feelings instead of anxiety, so that he/she may become desensitized to the anxiety caused by the closeness, and more comfortable engaging in intimate behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Waitlisted Intervention | Active comparator | Couple will be consented, assessed and randomized to a waitlist of 4 months. The couple will be reassessed at 8 weeks and prior to initiating intervention. Receives: Behavioral: Structured Approach Therapy |
| Immediate Intervention | Active comparator | Eligible couples who are randomized to immediate intervention will begin sessions with a trained interventionist within weeks of consent and initial assessments Receives: Behavioral: Structured Approach Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved couples communication as measured by standardized assessments
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Proposed studies were not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Responsible party
- Principal investigator, Shirley Glynn, University of California, Los Angeles
- Investigators
- Shrley M Glynn, PhD, Principal investigator, University of California, Los AngelesPatricia E Lester, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627548
- Sponsor's protocol ID
- 11-003109
- Acronym
- CCCV
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2012
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCLA Welcome Back Veterans Family Resilience Center Couples Counseling for Combat Veterans
- ClinicalTrials.gov ID
- NCT01627548
- Acronym / sponsor ID
- CCCV / 11-003109
- Conditions
- PTSD, Recent Era Combat Veteran, Couples Communication
- Keywords
- PTSD, Couples, Combat Veteran, Warfighter, OEF, OIF, OND, Structured Approach Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Proposed studies were not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 25 Jun 2012 (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.
A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlisted Intervention | Active comparator | Behavioral: Structured Approach TherapyCouple will be consented, assessed and randomized to a waitlist of 4 months. The couple will be reassessed at 8 weeks and prior to initiating intervention. |
| Immediate Intervention | Active comparator | Behavioral: Structured Approach TherapyEligible couples who are randomized to immediate intervention will begin sessions with a trained interventionist within weeks of consent and initial assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- OIF/OEF/ OND veteran with at least one deployment
- In a cohabitating relationship for 6 months or longer
- Cohabitating 50% of the time or more
- Diagnosed with PTSD or meets the diagnosis criteria for PTSD as related to deployment experience (CAPS)
- Ability to make weekly appointments
Key exclusion criteria (7 listed)
- Receiving an evidence-based treatment for PTSD within the past 6 months
- Receiving couples therapy within the last 6 months
- Moderate or excessive physical violence within the past 3 months (CTS)
- Alcohol/substance dependence (SCID)
- Known domestic violence/abuse (CTS)
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 |
|---|---|---|
| Structured Approach TherapyThe SAT treatment is provided in 12 weekly 50-minute sessions and is fully manualized. First, couple-based exposure techniques are used to address anxiety about intimacy, increasing the traumatized person's ability to engage in social and relational behaviors that promote bonding and satisfaction. Second, as anxiety decreases, couple-based techniques are also used to increase the positive experiences the couple is having. These activities expose the traumatized person to positive feelings instead of anxiety, so that he/she may become desensitized to the anxiety caused by the closeness, and more comfortable engaging in intimate behaviors. | Behavioural | Immediate Intervention, Waitlisted Intervention |
Primary outcome
Improved couples communication as measured by standardized assessments
Time frame: 4-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Shrley M Glynn, PhD principal investigator
University of California, Los Angeles
Patricia E Lester, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Approach Therapy in people with PTSD and Recent Era Combat Veteran, run by University of California, Los Angeles 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 7 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: withdrawn, as of the sponsor's last update on 3 Nov 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improved couples communication as measured by standardized assessments (time frame: 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.