Clinical trial NCT06252909: Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples
Official title: Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
PTSD
Intimate Partner Violence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* couples have mild to moderate forms of situational IPV (Ongoing Abuse Scale score = 1 or above). See below exclusion criteria for how severity will be determined.;
* both partners desire to maintain the relationship;
* woman identifies marital dispute as the main interpersonal problem area causing CMD symptoms.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)
timeFrame: measured at week 8
measure: IPT Fidelity Checklist
timeFrame: measured up to 8 weeks
measure: Mental Wellness Tool
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
Secondary outcomes:
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
measure: PTSD Checklist - Civilian Version (PCL-C)
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
measure: Revised Conflict Tactics Scale
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
measure: Dyadic Adjustment Scale
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: measured at pre-treatment and weeks 8, 12, 20, 32
Other outcomes:
measure: Adverse Childhood Experiences-International Questionnaire
timeFrame: measured at pre-treatment
Locations:
Study officials:
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