Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and… (NCT07749755) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and Promote Psychosocial Recovery in Veteran Couples (MERA-C)
United States120 participantsStarted 2027-01-01
Plain-language summary
This study will address a pressing unmet need for effective and accessible treatment for Veteran couples with intimate partner violence (IPV). The primary objective is to adapt a brief intervention originally developed to reduce general aggression among individual Veterans with PTSD symptoms (Manage Emotions to Reduce Aggression; MERA) to reduce IPV among Veteran couples. First, the investigators will conduct stakeholder interviews to inform the content, dose, and timing of the adapted MERA-Couples manual (MERA-C). Second, the investigators will examine the preliminary feasibility and acceptability of MERA-C through a single-arm feasibility trial among 10 Veteran couples with IPV. Finally, the investigators will conduct a pilot randomized controlled trial (N= 60 couples) to examine the preliminary within- and between-couple effects of MERA-C versus MERA on (1) participant acceptability and retention and (2) physical and psychological IPV occurrence; emotion regulation; relationship functioning; and psychosocial functioning from pre- to post-treatment and at 1-month follow-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least one partner in each couple must be a U.S. military Veteran
. Married, cohabiting, or in a committed relationship for at least 6 months
. Cognitive functioning sufficient to provide informed consent and participate accurately (≥ 23 on the Mini-Mental Status Exam \[MMSE\])
. Veteran meets criteria for subthreshold PTSD or greater (Criterion A plus scoring 2 or higher on at least one symptom from each of clusters B, C, D, and E as measured by the PCL-5)
. At least 1 instance of mild or moderate physical intimate partner violence (IPV) in the current relationship in the past year (as defined by the Revised Conflict Tactics Scale \[CTS-2\])
. Not currently enrolled in couple therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time Line Follow Back
Timeframe: 2 months
2
Difficulties in Emotion Regulation Scale
Timeframe: 2 months
3
Dyadic Adjustment Scale-7
Timeframe: 2 months
4
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results
Exclusion criteria
. Any severe physical or sexual IPV (as measured by the CTS-2) at any time in the current relationship
. Having a psychiatric condition requiring a higher level of care as assessed by the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID), such as psychotic or bipolar disorders. Those participants will be referred clinically.
. Severe substance use disorder. Nicotine dependence is allowed. Participants requiring specialty care for substance use disorders or smoking cessation aid will be referred clinically.
. Current suicidal, self-harm behavior, or homicidal ideation and intent requiring a higher level of care or who are likely to require hospitalization during the study. Those participants will be referred clinically.