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

NCT07749755 | Not Yet Recruiting DMC

• 2 other identifiers: RRD4-006-25W194392
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intimate Partner Violence

Keywords

Couples

Outcome Measures

Primary Outcomes (4)

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

Study Arms (2)

MERA-C

EXPERIMENTAL

Phase 3/Aim 3 of this study involves a behavioral intervention. Manage Emotions to Reduce Aggression-Couples (MERA-C). Although the exact duration and timing of MERA-C will be established in Aim 1, the investigators anticipate that MERA-C will be the same duration as individual MERA: 4 weekly couples/dyadic therapy sessions of 45-60 minutes each.

Behavioral: Manage Emotions to Reduce Aggression- Couples

MERA

ACTIVE COMPARATOR

Manage Emotions to Reduce Aggression (MERA). 4 weekly individual therapy sessions of 45-60 minutes each.

Behavioral: Manage Emotions to Reduce Aggression

Interventions

Manage Emotions to Reduce Aggression- Couples BEHAVIORAL

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

Also known as: MERA-C

MERA-C

Manage Emotions to Reduce Aggression BEHAVIORAL

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

Also known as: MERA

MERA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Study Officials

• Julianne Christina Flanagan, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianne C Flanagan, PhD

CONTACT

(843) 577-5011; julianne.flanagan@va.gov

Stacey S Sellers, MS

CONTACT

(843) 789-6703; Stacey.Sellers@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None - behavioral intervention cannot be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Phase 3/Aim 3 of this study involves a behavioral intervention. MERA-C. The investigators anticipate that MERA-C will include 3 weekly sessions of 45-60 minutes each. Sessions will be delivered either in-person or via telehealth. Each partner will receive a client workbook that will contain session content, practice worksheets to complete between sessions, and weekly tracking forms to monitor progress. The investigators plan for MERA-C to begin with goal setting, psychoeducation about the adaptive nature of emotions, and how adverse childhood, military, and life experiences influence emotion regulation. MERA-C will adapt the existing MERA psychoeducation content to include relationship functioning and partner-directed thoughts, emotions, and behavior, and how partners' emotional expression influences one another.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)