Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06252909
Enrollment
108
Registered
2024-02-12
Start date
2025-05-01
Completion date
2025-11-30
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Intimate Partner Violence, PTSD

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.

Interventions

BEHAVIORALInterpersonal 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).

BEHAVIORALInterpersonal 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.

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mental Wellness Toolmeasured at pre-treatment and weeks 8, 12, 20, 32The 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).
Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)measured at week 8The 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.
IPT Fidelity Checklistmeasured up to 8 weeksThe 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.

Secondary

MeasureTime frameDescription
PTSD Checklist - Civilian Version (PCL-C)measured at pre-treatment and weeks 8, 12, 20, 32The PCL-C is a standardized self-report scale for PTSD comprised of 17 items. It uses a 5-point scale where respondents indicate how much they have been bothered by a symptom (1 = Not at All \- 5 = Extremely). Items are totaled for a severity score (range = 17-85; 17-29 = little to no severity; 30-44 = moderate to moderately high severity; 45-85 = high severity).
Revised Conflict Tactics Scalemeasured at pre-treatment and weeks 8, 12, 20, 32The Revised Conflict Tactics Scale measures physical, psychological, and sexual intimate partner violence. It consists of 39 items are asked twice: once for respondent and once for partner. Item responses gauge frequency and range from Never to 20 or more times. It has five subscales: Negotiation, Psychological Aggression, Physical Assault, Injury, and Sexual Coercion.
Alcohol Use Disorders Identification Test (AUDIT)measured at pre-treatment and weeks 8, 12, 20, 32The AUDIT is comprised of 10 items that screen for hazardous or dependent drinking levels. Questions range from 0 to 4 with the exception of items 9 and 10 which have three response options and are scored 0, 2, 4. Items are summed. Score cut off points are 8 (hazardous drinking) and 13 women/15 men (alcohol dependence).
Dyadic Adjustment Scalemeasured at pre-treatment and weeks 8, 12, 20, 32The Dyadic Adjustment Scale (32 Likert items) measures relationship functioning and satisfaction. The four subscales include: Dyadic Satisfaction, Dyadic Consensus, Dyadic Cohesion, and Dyadic Affectional Expression. The score range is 1-151. A higher score indicates better adjustment to marriage.
Patient Health Questionnaire - 9 (PHQ-9)measured at pre-treatment and weeks 8, 12, 20, 32The PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring severity of depression. Score cut offs for depression are 5 (mild), 10 (moderate), 15 (moderately severe) and 20 (severe).
Generalized Anxiety Disorder - 7 (GAD-7)measured at pre-treatment and weeks 8, 12, 20, 32GAD-7 is a screening instrument with seven items to assess presence and severity of generalized anxiety severity. Scores range from 0 (not at all) to 3 (nearly every day) for a total range of 0 to 21. Score cut off points are 5 (mild), 10 (moderate), 15 (severe) anxiety.

Other

MeasureTime frameDescription
Adverse Childhood Experiences-International Questionnairemeasured at pre-treatmentThe Adverse Childhood Experiences- International Questionnaire (43 dichotomous (yes/no) and Likert scale items) measures adverse childhood experiences. Domains include family dysfunction; physical, sexual and emotional abuse and neglect by parents or caregivers; peer violence; witnessing community violence; and exposure to collective violence. A higher composite score indicates more adverse experiences an individual was exposed to in childhood.

Contacts

Primary ContactJennifer Mootz
jennifer.mootz@nyspi.columbia.edu6467746409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026