Treating Common Mental Disorders in Women in Mozambique by Addressing Intimate Partner Violence in Couples
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Mental Wellness Tool
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mental Wellness Tool
时间窗: measured at pre-treatment and weeks 8, 12, 20, 32
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).
IPT Fidelity Checklist
时间窗: measured up to 8 weeks
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.
Client Satisfaction Questionnaire Client Satisfaction Questionnaire - 8 (CSQ-8)
时间窗: measured at week 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.
次要结局
- Dyadic Adjustment Scale(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)
- Patient Health Questionnaire - 9 (PHQ-9)(measured at pre-treatment and weeks 8, 12, 20, 32)
- Revised Conflict Tactics Scale(measured at pre-treatment and weeks 8, 12, 20, 32)
- Alcohol Use Disorders Identification Test (AUDIT)(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)
研究者
Jennifer Mootz
Assistant Professor of Clinical Medical Psychology (in Psychiatry)
New York State Psychiatric Institute