Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples

NCT ID: NCT06252909

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-11-30

Brief Summary

Adapting mental health treatments to address modifiable interpersonal problems has the potential to improve and sustain outcomes in low-resource settings where treatment gaps persist. This K23 Award will prepare the candidate to become an independent investigator with high-impact public health research and expertise in couple-based interventions that address interrelated mental health problems and intimate partner violence in couples by gaining expertise in engagement and treatment of men, adapting an evidence-based treatment for common mental disorders to address IPV in couples, designing and conducting randomized controlled trials with couples, and professional skills development. This work has applicability for low-resource low-income countries and US populations that experience couple-based violence and the mental health treatment gap. With its focus on intimate partners, the intervention also has the potential to benefit health and wellbeing of children.

Conditions

Depression; Anxiety; PTSD; Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interpersonal Psychotherapy for Couples

Group Type: EXPERIMENTAL

Interpersonal Psychotherapy for Couples

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy for Couples (IPT-C) consists of 8 weekly conjoint sessions. The clinical goals are to "promote resolution of the role dispute via renegotiation of role relations between the marriage partners" and improve common mental disorders in the woman. Like Interpersonal Psychotherapy, IPT-C has an initiation phase (Session 1-2), middle phase (Sessions 3-6), and termination phase (Sessions 7-8).

Interpersonal Psychotherapy (Individual)

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy (Individual)

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy (IPT) is an evidence-based treatment to reduce depression and other common mental disorders. It focuses on helping patients resolve interpersonal problems of disagreements, loneliness, life changes, and grief, and/or change their orientation to the problem.

Interventions

Interpersonal Psychotherapy for Couples

Interpersonal Psychotherapy for Couples (IPT-C) consists of 8 weekly conjoint sessions. The clinical goals are to "promote resolution of the role dispute via renegotiation of role relations between the marriage partners" and improve common mental disorders in the woman. Like Interpersonal Psychotherapy, IPT-C has an initiation phase (Session 1-2), middle phase (Sessions 3-6), and termination phase (Sessions 7-8).

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy (Individual)

Interpersonal Psychotherapy (IPT) is an evidence-based treatment to reduce depression and other common mental disorders. It focuses on helping patients resolve interpersonal problems of disagreements, loneliness, life changes, and grief, and/or change their orientation to the problem.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Both partners aged ≥18;
• both partners identify each other as one of (in case of polygamous marriage) their primary sexual partners of the opposite sex;
• partnered for at least 3 months;
• woman screens positive for a CMD using the Mental Wellness Tool developed and validated by our PRIDE team in Mozambique;

Exclusion Criteria

• both partners desire to maintain the relationship;
• woman identifies marital dispute as the main interpersonal problem area causing CMD symptoms.

• Any indicators of severe IPV. The determination of severity will be assessed using items (presence or absence) on the Conflict Tactics Scale (CTS). If any couple member answers yes to both of the following items: "I punched or hit my partner with something that could hurt" and "I kicked my partner," couples will be excluded. Couple members who answer yes to any of the following items: "I used a knife or gun on my partner," "I choked my partner," "I slammed my partner against a wall," "I beat up my partner," "I burned or scalded my partner on purpose," will be excluded. Finally, if any couple member reports that a violent behavior was repeated at least six times in a year by their partner or themselves, violence will be considered severe.;
• (2) discrepancy (>2) in reporting of frequency of violence on CTS in overall average scores of the partners or for any single behavior in the scale. For example, if the female partner reports that her male partner slapped her three times, but the male partner reports that he never slapped his female partner, the couple will be excluded for discrepant reporting for the act of slapping.;
• history of violent legal offences;
• male partner has severe CMD symptoms (PHQ-9 score of 20 or above; GAD-7 score of 15 or above; and PCL-C score of 45 or above); and either partner demonstrates/reports
• serious mental illness,
• cognitive impairment,
• history of mania (Psychosis Screening Questionnaire score = 1),
• hazardous alcohol use (AUDIT score of 8 or above),
• current suicidality,
• not speaking Portuguese,
• feeling unsafe to participate,
• inability to complete the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mootz

Assistant Professor of Clinical Medical Psychology (in Psychiatry)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jennifer Mootz

Role: CONTACT

jennifer.mootz@nyspi.columbia.edu

6467746409

Other Identifiers

K23MH122661

Identifier Type: NIH

Identifier Source: org_study_id

View Link