Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and Promote Psychosocial Recovery in Veteran Couples (MERA-C)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manage Emotions to Reduce Aggression- Couples

    Behavioral

    4 weekly dyadic/couples therapy sessions of 45-60 minutes each.

  • Manage Emotions to Reduce Aggression

    Behavioral

    4 weekly individual therapy sessions of 45-60 minutes each.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: MERA-CExperimental treatment 1 intervention
Group B: MERAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time Line Follow Back

The Time Line Follow-Back (TLFB) will be used as the primary IPV assessment given the need for a count variable to compare time points at varying intervals. The TLFB is a calendar-assisted, semi-structured interview assessing daily quantity and frequency of alcohol and drug consumption (e.g., cannabis) and IPV use and victimization. Participants report the total number of days substances are used and the amount of substance used (e.g., standard drink units for alcohol) and the days on which IPV use and/or victimization occurred as well as each partner's specific IPV behaviors. The TLBF will be administered at baseline to study participation and at each subsequent time point.

Time frame
2 months
2

Difficulties in Emotion Regulation Scale

The Difficulties in Emotion Regulation Scale (DERS-16) is a 36-item self-report measure that assesses 6 facets of emotion regulation: nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Respondents are asked to indicate how frequently each item applies to them, from 1 ("almost never, 0-10% of the time") to 5 ("almost always, 91-100% of the time"). Higher scores indicate greater difficulties with emotion regulation. The DERS has demonstrated strong internal consistency and good construct validity among treatment-seeking adults.

Time frame
2 months
3

Dyadic Adjustment Scale-7

The Dyadic Adjustment Scale-7 (DAS-7) is a psychometrically sound alternative to the original 32-item measure. The DAS-7 assesses domains of relationship functioning. Six items are rated on a 6-point Likert scale and 1 item is rated on a 7-point scale, for a total score ranging from 0-36 (higher scores indicate more positive relationship adjustment and less distress). The DAS-7 has demonstrated good internal consistency and construct validity and effectively discriminates between distressed and non-distressed couples.

Time frame
2 months
4

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16-item self-report measure assessing overall enjoyment and satisfaction with life domains. Responses range from 1 ("not at all or never") to 5 ("frequently or all the time"). Fourteen items are summed to create a total score of 14-70, with higher scores indicating greater life satisfaction. There is no specific clinical cutoff score for this measure. The two items that are not included in the total score assess medications and overall life satisfaction. The Q-LES-Q-SF has demonstrated strong psychometric properties, is sensitive to change over time, and is suitable for assessing treatment outcomes.

Time frame
2 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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