Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Impact on Behavioural Engagement with Integration
研究概览
简要总结
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions. If group integration therapy is beneficial, then it has the potential to reduce resources required per patient for psilocybin-assisted psychotherapy, thereby increasing the cost-effectiveness of the treatment. However, no research has been done to understand if and how group therapy can support psychedelic integration for people with mood disorders. Therefore, the purpose of this study is to explore the benefit of psilocybin-assisted group therapy and to determine if psychedelic group integration therapy is acceptable to people who have received psychedelic-assisted therapy for mood disorders.
详细描述
This study is a phase II, single-arm, single-site, 21-week study evaluating efficacy, feasibility, and acceptability of psychedelic group integration therapy. Participants will join 10 group therapy sessions that will facilitate the integration of insights gained from PAP into their day-to-day lives. The study will explore pre- and post- intervention measures and integrate qualitative data with quantitative data to examine feasibility and efficacy.
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
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •Stated willingness to comply with group integration requirements (i.e., maintaining confidentiality of other group members and group etiquette);
- •Stated willingness to commit to attending all group sessions. Of note, participants who miss a group session will not be penalized, provided they have communicated their anticipated or unanticipated absence with the study therapist(s);
- •Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form, study questionnaires and group participation, as evaluated by study staff obtaining consent;
- •Met all the inclusion criteria and none of the
排除标准
- •of either the PSI-1V2 or Psilo-BD clinical trials.
- •Completed the Primary Endpoint measures as part of the PSI-1V2 or Psilo-BD clinical trials.
- •Participants who are actively receiving therapy outside of this study are eligible to participate, provided the external therapy they are receiving is not psilocybin-assisted group integration psychotherapy.
- •Exclusion Criteria:
- •Active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past month;
- •Withdrawal, dropout, loss to follow-up, or demonstrated significant study intervention non-compliance of either the PSI-1V2 or Psilo-BD clinical trials.
- •Any behaviors that, in the opinion of the investigator, may interfere with the group therapy model (e.g., participants in acute crisis, demonstrated resistance to the therapeutic process of the main clinical trials, etc.);
- •Participants who are actively receiving psilocybin-assisted group integration psychotherapy outside of the study.
结局指标
主要结局
Impact on Behavioural Engagement with Integration
时间窗: From enrolment to the primary endpoint (Week 21)
Evaluated using the Integration Engagement Scale, a 12-item self-report rating scale, where higher scores indicate greater engagement.
次要结局
- Self-Reported Depression Symptoms(From enrolment to the end of the program (Week 17))
- Self-Reported Wellbeing(From enrolment to the end of the program (Week 17))
- Self-Reported Anxiety Symptoms(From enrolment to the end of the program (Week 17))
- Self-Report of the Intrapsychic Experience of Integration(From enrolment to the primary endpoint (Week 21))
- Post-Psychedelic Growth(From enrolment to the primary end point (Week 21))
- Self-Reported Connectedness(From enrolment to primary endpoint (Week 21))
研究者
Joshua Rosenblat
Psychiatrist
University Health Network, Toronto