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

NCT06252909 | Not Yet Recruiting DMC

• 1 other identifier: K23MH122661
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)

  The Client Satisfaction Questionnaire - 8 measures respondents' opinions about services they have received. Responses are based on a four-point scale (ranging from very negative to very positive), but the options differ depending on the item. Scores range from 8 to 32; higher values indicate higher satisfaction. Scores are calculated by summing scores across all items.

  measured at week 8

• IPT Fidelity Checklist

  The IPT Fidelity Checklist measures provider fidelity to Interpersonal Therapy. Providers are assessed for low (1), moderate (2), or high (3) adherence to each treatment element. A total score is calculated y summing individuals items. The PRIDE team has adapted this Checklist for Interpersonal Counseling, which will be further adapted in the proposed study for couple-based treatment.

  measured up to 8 weeks

• Mental Wellness Tool

  The Mental Wellness Tool was developed and validated by the PRIDE team in Mozambique to screen for and differentiate cases according to presence or absence of common mental disorders, severe mental illness, substance use disorders, and suicidal risk. Patients are asked three initial questions. If they respond positively to any of the 3 items, they are asked 10 additional items. The Mental Wellness Tool will be used to screen patients for common mental disorders and exclude patients with severe mental illness, substance use disorders, or suicidality. It will additionally be used to track metrics to determine Reach (i.e., number in need).

  measured at pre-treatment and weeks 8, 12, 20, 32

Secondary Outcomes (6)

• Patient Health Questionnaire - 9 (PHQ-9)

  measured at pre-treatment and weeks 8, 12, 20, 32

• Generalized Anxiety Disorder - 7 (GAD-7)

  measured at pre-treatment and weeks 8, 12, 20, 32

• PTSD Checklist - Civilian Version (PCL-C)

  measured at pre-treatment and weeks 8, 12, 20, 32

• Revised Conflict Tactics Scale

  measured at pre-treatment and weeks 8, 12, 20, 32

• Dyadic Adjustment Scale

  measured at pre-treatment and weeks 8, 12, 20, 32

Other Outcomes (1)

• Adverse Childhood Experiences-International Questionnaire

  measured at pre-treatment

Study Arms (2)

Interpersonal Psychotherapy for Couples

EXPERIMENTAL

Behavioral: Interpersonal Psychotherapy for Couples

Interpersonal Psychotherapy (Individual)

ACTIVE COMPARATOR

Behavioral: Interpersonal Psychotherapy (Individual)

Interventions

Interpersonal Psychotherapy for Couples 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 for Couples

Interpersonal Psychotherapy (Individual) 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.

Interpersonal Psychotherapy (Individual)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible women and their male partners will be recruited for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Interpersonal Psychotherapy; Family Characteristics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Jennifer Mootz

CONTACT

6467746409; jennifer.mootz@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medical Psychology (in Psychiatry)

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 12, 2024
• Study Start: May 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: November 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2024-05