An Online/In Person Program Assessing Acceptance Commitment Therapy Matrix Plus Contingency Management for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of intervention
研究概览
简要总结
This study aims to assess the feasibility, acceptability and preliminary effectiveness of Acceptance Commitment Therapy, in conjunction with motivation enhancement, and the use of the ChillTime App, in reducing methamphetamine use in women with MUD with or without co-occurring psychiatric disorders. This intervention is designed to be delivered remotely (e.g., participants can complete the entire study from home), with the option for in person attendance if it is not feasible or safe for participants to attend from home.
详细描述
Women and gender non-conforming (GNC) individuals with methamphetamine use disorder (MUD) are a particularly vulnerable population in need of complex interventions that can address the range of severe clinical issues with which they often present. However, there are currently no existing psychosocial interventions that are considered preferred for MUD generally, much less in women and GNC individuals with complex psychological profiles and social positioning.
Complex interventions refer to a multifaceted approach to the treatment of psychiatric conditions and may consist of several therapeutic modalities (e.g., behavioural, pharmacological, technological, family engagement; May et al., 2007). These interventions are designed with the intent that they are easy to incorporate into everyday clinical practice (May et al., 2007) and will be effective in treating members of the general population, who present with complex conditions.
As such, the investigators aim to assess the feasibility, acceptability, and effectiveness of a) Acceptance Commitment Therapy delivered in a group format twice weekly, b) an intrinsic motivation building session and contingency management (i.e., progressive monetary incentivizing) targeting session attendance, and c) the ChillTime App to promote the use of emotional coping strategies between sessions.
The program will be 15 sessions/8 weeks long with outcome data collected at a 1-month follow up to assess longevity of effects on MUD harm reduction, abstinence, and mental health.
The investigators will recruit 60 participants through existing service providers in the Greater Toronto Area. As a broader aim of our study is to promote generalizability to the community and ensure the intervention will be accessible to all women and GNC individuals with MUDs, the following are implemented: a) group sessions will be delivered remotely, with an option for in person attendance if remote access is not feasible; b) broad inclusion criteria (e.g., not excluding on the basis of other mental health/substance use comorbidities); and c) qualitative interviews during which patient perspectives will be gathered and the intervention will be adapted accordingly, where warranted. Results will be used to inform a large-scale, randomized, controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Meet SCID DSM-5 criteria for Methamphetamine Use Disorder
- •Over the age of 18
- •Female, woman, or non-binary and comfortable participating in women's group
- •Capacity to provide informed consent
- •Adequate English language abilities
排除标准
- •Experiencing acute or unmedicated psychosis that would reasonably prevent them from engaging in and/or benefiting from the intervention
- •Experiencing acute and severe suicidal ideation such that institutionalization and supervised care is warranted
- •Experiencing severe cognitive deficits that would reasonably prevent them from consenting, engaging in, and/or benefiting from the intervention
研究组 & 干预措施
Intervention Arm
Participants will complete the baseline session, a 1:1 motivation building session, and 8 weeks of ACT group therapy. They will then complete a final study visit and a follow-up study visit to occur 6 month after the end of therapy.
干预措施: Acceptance Commitment Therapy (Behavioral)
结局指标
主要结局
Feasibility of intervention
时间窗: Immediately after intervention
Rates of eligible participants who agree to participate in the study intervention; Rates of retention in program (e.g., number of participants that completed all 15 sessions, number of participants that completed at least a full dose of 10 sessions, number of participants that dropped out before 10 sessions); Rate of use of ChillTime App
Acceptability of intervention
时间窗: 1 month follow-up
Acceptance and understanding of the program using qualitative assessments at the end of study and the Client Satisfaction Questionnaire
次要结局
- Changes in methamphetamine use via the timeline followback (TLFB)(Baseline, immediately after intervention, 1 month follow-up)
- Changes in methamphetamine use via urinalysis(Baseline, immediately after intervention, 1 month follow-up)
- Changes in other substance use via the Timeline Followback (TLFB)(Baseline, immediately after intervention, 1 month follow-up)
- Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)(Baseline, immediately after intervention, 1 month follow-up)
- Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)(Baseline, immediately after intervention, 1 month follow-up)
- Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ)(Baseline, immediately after intervention, 1 month follow-up)
- Engagement in treatment(Immediately after intervention)
- Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2(Baseline, immediately after intervention, 1 month follow-up)
- Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS(Baseline, immediately after intervention, 1 month follow-up)
- Drug use or harm reduction practices at the end of the study via semi-structured interviews(1 month follow up)
- Barriers to engaging in the intervention using qualitative assessments at the end of study(1 month follow up)
- Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF](Baseline, immediately after intervention, 1 month follow-up)
研究者
Bernard Le Foll
Senior Scientist
Centre for Addiction and Mental Health
