Effectiveness of Peer Counseling in Addressing Psychological Distress and Exposure to Violence Among LGBTIQA+ Population in Nepal: A Three-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 960
- 试验地点
- 12
- 主要终点
- General Health Questionnaire (GHQ-12)
研究概览
简要总结
Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual, and other sexually or gender diverse (LGBTIQA+) communities in many countries face high levels of mental health problems compared to the general population. This is often due to discrimination, being excluded, abuse, and unfair treatment. In many low- and middle-income countries, including Nepal, the mental health needs of LGBTIQA+ people are not met, and the violence they experience is often ignored because they are seen as breaking gender norms. The low number of trained mental health specialists in a country like Nepal imply that any short-term effort to alleviate the mental health problems among LGBTIQA+ must rely on other type of support workers such as peers. There is growing evidence that help from community members-such as counselling given by non-professionals-can improve mental well-being. Considering that discrimination of LGBTIQA+ is common also within the health services, this study will look at whether peer counselling-support provided by trained LGBTIQA+ community members-can work well in Nepal. We have improved a counselling program called 'Problem Management Plus' (PM+), developed by the World Health Organization, by adding new parts that focus on reducing the risk of some of the contributing causes of mental distress, namely violence, marginalisation and loneliness. The added components include safety planning, counselling that builds confidence and strength, and goal setting strategies to help study participants use the skills they learn and reach the desired impact. In addition, peer-led monthly group meetings will be conducted to enhance social cohesion, strengthen interpersonal networks, and reduce feeling of loneliness. The study uses a community based participatory research approach, meaning LGBTIQA+ people are invited to give inputs throughout the study from study design to being involved as peer advocates to deliver the counselling. The trial will recruit at least 960 LGBTIQA+ individuals aged 18 to 55 years living in seven districts of Nepal. Study participants will be randomly allocated to one of three arms: one arm receiving individual augmented PM+ counselling with six weekly sessions; one arm receiving the individual augmented PM+ counselling followed by 11 monthly group sessions; and one control arm. There will be a one year follow-up to examine whether the peer support helps improve mental health and reduce exposure to violence among LGBTIQA+ people. The study findings will help guide programmes to improve the mental health of LGBTIQA+ in other low- and middle-income countries where they also experience discrimination, exclusion, and violence.
详细描述
Sexual and gender minorities, including Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual and other sexually or gender diverse (LGBTIQA+) individuals, disproportionately experience social stressors such as discriminatory attitudes, violence, prejudice, and stigmatization. This environment leads to negative health outcomes, including physical ailments and risky health-related behaviors (e.g., smoking, drug abuse, and inconsistent condom usage), as well as mental health problems, ultimately impacting the overall well-being of these vulnerable groups. LGBTIQA+ individuals often anticipate rejection and discrimination from the majority population, which leads to constant vigilance, identity concealment, and self-stigma. These factors negatively affect self-acceptance and exacerbate psychological distress. Despite the high burden of violence and mental illness, LGBTIQA+ individuals tend to use health services less frequently than the majority population in many countries. This is due to fears of discrimination also from health professionals and prior experiences of disrespectful treatment and poor communication. To meet the violence prevention and mental health needs of LGBTIQA+ individuals in low- and middle-income countries (LMICs) and reduce health inequalities, culturally relevant, low-cost interventions that do not require highly trained professionals are needed.
The overall objective of this trial is to evaluate the effectiveness of a multicomponent intervention (SAATHI) in reducing exposure to violence and psychological distress among LGBTIQA+ people in Nepal. This project utilizes a mixed-method research design, and the trial had been preceded by formative research with qualitative interviews and focus group discussions with key stakeholders to evaluate the feasibility and acceptability of the intervention package. The three-armed randomized controlled trial will be implemented in seven districts across two provinces in Nepal. A qualitative process evaluation will be conducted during the intervention delivery.
We will enroll at least 960 LGBTIQA+ participants in the trial. The inclusion criteria are: age 18-55 years, history of surviving violence in the previous 12 months, and a score of ≥3 on the General Health Questionnaire indicating psychological distress.
The participants allocated to the two intervention arms will receive six weekly 90-minute counseling sessions covering multiple topics. The counselling aims to mitigate the psychological effects of trauma and moderate the impacts of a stressful, coercive, and threatening environment by altering individuals' appraisal of stressful events, modify coping patterns, and promote self-regulation, self-esteem, and positive feelings about LGBTIQA+ identity. In one of the intervention arms the participants will also be invited to 11 monthly group sessions after the individual counselling to enhance social support and social cohesiveness. The counselling and the group sessions will be offered by peer advocates who have received a 10-day training in counselling and group facilitation.
The trial participants will be followed up for one year to assess changes in exposure to violence and mental health status. The primary outcome will be GHQ-12 score. The effectiveness analysis will be based on intention-to-treat principles. The intervention effects on outcomes will be assessed using mean differences for continuous outcomes and risk ratios and absolute risk differences for binary variables.
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)
盲法说明
The outcome assessors will be independent from the intervention team and will not be involved in delivering the intervention. They will be masked to participant's group assignment in order to reduce bias, ensure objective data collection, and minimize measurement bias during the assessment of study outcomes.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as a member of the LGBTIQA+ community
- •Aged 18 to 55 years
- •Have a history of exposure to any form of violence (physical, sexual, or psychological) within the past 12 months
- •Exhibit psychological distress, defined as a score of more than or equal to 3 on the General Health Questionnaire (GHQ-12)
排除标准
- •Express current suicidal ideation or plans to end their life
- •Meet diagnostic criteria for substance use disorders, including alcohol or drug dependence
- •Have severe functional impairment due to a mental, neurological, or developmental disorder (e.g., severe intellectual disability, dementia, or psychosis)
- •Decline or are unable to provide informed consent
- •Intend to relocate from the study districts or move outside the country within the next few months
研究组 & 干预措施
Control Arm (Arm 1)- Usual Standard Care
Standard care includes all available mental health and violence prevention services in the study area. If participants are found to have severe psychological distress or are at risk of suicide at any time during the study, they will be referred to a mental health professional. The study team includes psychiatrists and psychosocial counselors who will be available to provide remote counseling or in-person consultations, if needed. If free services are not available, the study will arrange appointments, cover consultation fees, and support travel costs for up to five sessions. A leaflet with mental health information, practical tips, and contact details for support organizations (including 24-hour suicide prevention hotlines) will be provided. Participants will also be referred to One Stop Crisis Management Centers for counseling, medical treatment, and legal support for survivors of violence.
Arm 2- SAATHI intervention (Augmented PM+ counseling)
In addition to standard care, participants in the SAATHI intervention (Arm 2) will receive peer-led augmented Problem Management Plus (PM+) counseling, along with safety planning.
干预措施: SAATHI intervention (Augmented PM+ counseling) (Behavioral)
Arm 3- SAATHI intervention with Peer-Led Group Meetings
Participants in Intervention Arm 3 will receive the same counselling as those in Arm 2, consisting of six weekly peer-led sessions. In addition, they will take part in 11 monthly peer-led group support meetings.
干预措施: SAATHI intervention with Peer-Led Group Meetings (Behavioral)
结局指标
主要结局
General Health Questionnaire (GHQ-12)
时间窗: Baseline Assessment; Follow up at 47 weeks after SAATHI counselling completion (53 weeks after baseline assessment). Note: This variable will also be assessed as a secondary outcome at 7 weeks and 18 weeks after baseline.
The General Health Questionnaire (GHQ-12) will be used to assess psychological distress among study participants. The GHQ-12 consists of 12-items and, when scored using the Likert method, resulting in a total score ranging from 0 to 36, with higher scores indicate greater levels of psychological distress. Participants will be asked to reflect on their experiences over the past two weeks. The mean score will be used as a measure of mental distress.
Experience of violence
时间窗: Baseline Assessment; Follow up at 53 weeks after baseline assessment. Note: Experiences of violence (type-specific violence and severity/high-intensity violence) as a secondary outcome will be assessed at 18 weeks and at 12 months.
Experience of violence will be measured using a modified version of WHO multi-country questionnaire on women's health and domestic violence. The adapted tool assesses the prevalence and type of violence experienced by study participants at different time points. This will be measured as a binary variable with the value 1 if a participant has experienced any type of violence in the specified recall period, and 0 if they have not experienced any recent violence. The following categories are included in the definition of violence: controlling behaviors, psychological violence, physical violence, and sexual violence. The recall period for experience of violence at baseline will be the past 12 months. Changes in the experience of violence at follow-up assessments will be measured relative to baseline.
次要结局
- Post-Traumatic Stress Disorder Symptoms (PCL-5)(Baseline Assessment; Follow up at one-week post-counselling (7 weeks after baseline); Follow up at 47 weeks post-counselling (53 weeks after baseline))
- Modified Collective Self-Esteem Scale(Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).)
- Daily functioning (WHODAS 2.0- 12-item version)(Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks post-counselling (53 weeks after baseline))
- Neff's Self-Compassion Scale (Short- form)(Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).)
- MOS Modified Social Support Survey- Five Item Version (MSSS-5)(Baseline Assessment; Follow up at 47 weeks post-counselling (53 weeks after baseline).)
- Modified Safety Planning Checklist(Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).)
- Use of Community Resources(Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).)
- Psychological Outcomes(Intervention arm: Pre-counseling, during sessions 2-5, Follow-up 1 at one-week post-counseling and Follow-up 2 at 12 weeks after post-counseling. Enhanced usual care arm: Baseline, Follow-up 1 at 7 weeks, and Follow-up 2 at 18 weeks post-baseline.)