A Trial for an Integrated Cognitive Behavioural Therapy to Treat PTSD and Sexually Transmitted Infections Among Gay, Bisexual, and Other Men Who Have Sex with Men
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Condomless anal sex (CAS) with casual partners, based on response at 6 months.
研究概览
简要总结
Gay, bisexual, queer, and other men who have sex with men (GBM) continue to bear a disproportionate burden of the sexually transmitted and blood-borne infections (STBBI), largely attributable to efficient transmission during condomless anal sex (CAS; Baggaley et al., 2010). In 2022, GBM accounted for 38.1% of new HIV diagnoses in Canada (Public Health Agency of Canada, 2023). Incidence of syphilis, chlamydia and gonorrhea have risen among men who have sex with men (MSM), especially among HIV+ GBM living in Canadian urban centres, including Toronto and Quebec (Public Health Agency of Canada, 2022). Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men (Roberts et al., 2010). Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM (O'Cleirigh, 2019). Despite the strong association between PTSD and STBBI risk among GBM, no studies have examined the efficacy of PTSD treatment on STBBI risk among GBM. PTSD may also increase substance use in sexual situations, another risk factor for STBBIs among GBQM (Semple et al., 2011; Elkington et al., 2010). Substance use tends to follow PTSD because alcohol and other substances are often used to self-medicate trauma symptoms (as an avoidant coping strategy) in interpersonal situations (Tan et al., 2021). Alcohol and substance use in sexual situations are consistent risk factors for CAS among Canadian GBQM (Lambert et al., 2011), and are associated with higher HIV incidence. Due to consistent data linking substance use to STBBI risk, it has been suggested that incorporating alcohol and substance use treatment into sexual risk reduction counselling (Koblin et al., 2006; Parsons et al., 2005; Shoptaw & Frosch, 2000) may increase the efficacy of STBBI prevention efforts for GBQM. PTSD is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy (CPT; Benight & Bandura, 2004; Monson & Shnaider, 2014; Watkins et al., 2018).
The present study will provide preliminary feasibility and acceptability data for a novel and innovative STI/HIV prevention intervention for GBQM. This intervention builds upon empirically supported treatments for PTSD, including PTSD-related substance use, by adding risk reduction counselling to reduce sexually transmitted infections (STI) and HIV sexual risk behaviour. The present study will provide trial data for a novel and innovative STBBI prevention psychotherapy for GBM that could be administered by mental health providers across Canada. The intervention will consist of 14 90-minute sessions of an integrated cognitive-behavioural approach using CPT to treat PTSD and to reduce STBBI risks among GBQM. The primary outcome will be condomless anal sex with casual partners. The secondary outcomes will be PTSD prevalence, trauma symptoms, problematic substance use, sexual risk, and PTSD-related avoidance of negative thoughts and feelings.
This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Live in Ontario or Quebec (able to travel to Toronto Metropolitan University or CLSC de Cote-des-Neiges, respectively)
- •Identify as a man
- •Are over 18 years of age
- •Have had anal sex without a condom with a person assigned male at birth in the past 3 months
- •Have experienced symptoms consistent with a diagnosis of PTSD
- •Are able to read, speak, and understand English
排除标准
- •if a 14-session protocol is deemed inappropriate for their treatment needs (e.g., psychotic or bipolar disorders not well-managed by medications)
- •if either our assessors or therapists identify that a participant's ability to respond to study measures is compromised by mental or physical disabilities or inability to speak and understand English
结局指标
主要结局
Condomless anal sex (CAS) with casual partners, based on response at 6 months.
时间窗: 3-months following final treatment session
Participants will indicate frequency of CAS and number of casual sex partners, defined as partners of less than a 6-month duration for 1) insertive and receptive anal sex and vaginal or frontal sex both with and without a condom, in the past 3 months.
次要结局
- PTSD Measures(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Self-Report Measures - PTSD(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Self-Report Measures - Sexual behavior(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Change in Clinical diagnosis and Severity of Mental Health Symptoms(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Self-Report Measures - Substance Use.(baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up)
- Qualitative Exit Interview(post-intervention (an average of 16-18 weeks after baseline))
研究者
Trevor Hart
Professor
Toronto Metropolitan University
