跳至主要内容
临床试验/NCT03794986
NCT03794986已完成不适用

Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors

Yale University2 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
356
试验地点
2
主要终点
Number of Participants Who Engage in Mental Health Treatment

研究概览

简要总结

The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.

详细描述

Through workshops and ongoing supervision/consultation, researchers will train MaleSurvivor peer leaders to competently deliver both versions of MI and conduct a randomized controlled trial comparing the two versions of MI to enhance treatment engagement in SGM male survivors with mental health problems. All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week MI delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Randomization will be counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment but not within the past 60 days).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 18 years or older
  • English-speaking; men who have sex with men or individuals identifying as SGM males
  • Individuals who report a history of sexual abuse and individuals who self-report a minimum cut-off score of 3.0 or higher on emotional distress, using a 4-question symptom inventory.

排除标准

  • Individuals who endorse active psychosis
  • Individuals who have a cognitive dysfunction
  • SGM men who report that they are currently in formal mental health counseling

结局指标

主要结局

Number of Participants Who Engage in Mental Health Treatment

时间窗: Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.

The number of participants who initiated mental health treatment/reinitiated mental health treatment versus those who did not. Mental health treatment engagement will be operationally defined as having ≥1 visit(s) or scheduled appointments to any mental health services within 120 days of the last online group.

Center for Epidemiological Studies Depression Scale

时间窗: Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.

This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder.

次要结局

  • Post Traumatic Stress Disorder(Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.)
  • Psychosocial Functioning(Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day)
  • Substance Abuse(Post-intervention (immediately following last online group))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验