Determining the Feasibility and Effectiveness of Psychotherapy for Transgender Clients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Measuring 3 month and 9 month Change in the Outcome Questionnaire 45; Lambert et al., 2013
研究概览
简要总结
Transgender and gender diverse (TGD) individuals are at an increased risk for mental health concerns, including anxiety, trauma-based distress, depression, self-harm, and suicidality. Quantitative and qualitative studies have shown that support appears to mediate mental health concerns, but to date, there have been zero psychotherapy studies focusing on transgender and gender diverse patients. The NIH has noted that TGD patients are considered to be a "health disparities population," indicating that there is considerable research to support prevention and reduction in mental health disparities for this population.
There are two aims to the current study-Aim 1: investigate the feasibility of conducting a psychotherapy randomized controlled trial for transgender and gender diverse populations, and Aim 2: longitudinally investigate the impact of minority stress interventions on well-being for transgender and gender diverse patients.
First, it is hypothesized that this study will demonstrate feasibility regarding recruitment of transgender and gender diverse patients and that patients from both groups will report treatment acceptability. We also hypothesize that patients will report more acceptability for treatments that are focused on minority stress interventions. It is hypothesized that individuals in both the Minority Stress Treatment (MST) group and Treatment as Usual (TAU) group will both show improvements in well-being, but that the MST group will demonstrate larger effects in outcomes.
No known published studies have focused on minority stress psychotherapy interventions for transgender and gender diverse populations. The findings from the proposed study will provide a multitude of information regarding longitudinal psychotherapy interventions focusing on minority stress that will inform future treatment manuals and larger, multi-site studies.
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
- Double (Participant, 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
- 是
入选标准
- •Age of 18 or older
- •Fluent in written and spoken English
- •Willingness to participate in pre/post/session-by-session assessments and 12 ----Individual psychotherapy treatment sessions
- •Individual identifies as transgender, trans, or non-binary (or somewhere along the gender minority spectrum).
排除标准
- •Under 18 years old
- •Reports current, unmanaged psychotic symptoms or symptoms requiring immediate inpatient treatment (e.g., hallucinations, delusions, threatening immediate suicidal behaviors)
- •Currently engaging in psychotherapy
- •Cannot attend therapy on Tuesdays from 2-7pm
- •Individuals who lack the capacity to provide consent will be excluded.
结局指标
主要结局
Measuring 3 month and 9 month Change in the Outcome Questionnaire 45; Lambert et al., 2013
时间窗: Prior to Week 1 (within 2 weeks of Week 1), 3 months, 9 months (within 6 months of study completion)
Measures overall mental health (symptom distress, interpersonal relations, social role). This is a 45-item likert scale. The total score ranges from 0 - 180 and includes a cutoff score of 63 or more (indicating symptoms of clinical distress). Higher scores suggest more symptoms of distress and difficulties in relationships. For symptom distress, scores range from 0-100 and the clinical cutoff score is 36 or more. For interpersonal relations, scores range from 0-44 and has a cutoff score of 15 or more. For social role, the range is 0-36 and includes a cutoff score of 12 or more. For all scales, higher scores indicate more distress. All scales are summed.
Measuring Weekly Change in the Outcome Questionnaire 45; Lambert et al., 2013
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, 3 months, 9 months (within 6 months of study completion)
Measures overall mental health (symptom distress, interpersonal relations, social role). This is a 45-item likert scale. The total score ranges from 0 - 180 and includes a cutoff score of 63 or more (indicating symptoms of clinical distress). Higher scores suggest more symptoms of distress and difficulties in relationships. For symptom distress, scores range from 0-100 and the clinical cutoff score is 36 or more. For interpersonal relations, scores range from 0-44 and has a cutoff score of 15 or more. For social role, the range is 0-36 and includes a cutoff score of 12 or more. For all scales, higher scores indicate more distress. All scales are summed.
次要结局
- Measuring 3 month and 9 month Change in the World Health Organization WHOQOL-BREF Quality of Life Assessment (WHOQOL-BREF); Power, 1998(Prior to Week 1 (within 2 weeks of Week 1), 3 months after starting Week 1, and 9 months after Week 1)