ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence, Severity, and Frequency of Adverse Events
研究概览
简要总结
ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder.
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation.
The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.
详细描述
ADEPT is an open-label proof-of-concept study designed to assess the safety and tolerability of combining psilocybin-assisted therapy with Dialectical Behavior Therapy in participants with borderline personality disorder.
The study will enroll up to 18 participants who have a confirmed DSM-5 diagnosis of borderline personality disorder and are enrolled in the M Health Fairview Dialectical Behavior Therapy program. Participants must have been enrolled in DBT for at least one month and must have consistent attendance in both group and individual therapy.
The study intervention includes two 25 mg doses of psilocybin administered during supervised dosing visits. Three preparation therapy visits will occur before the first dosing visit. The first dosing visit will be followed by three integration therapy visits. A second psilocybin dosing visit will occur approximately 21 days later, followed by three additional integration therapy visits. Participants will complete a final follow-up visit at week 18, approximately 12 weeks after the second dosing visit.
Participants will continue their usual DBT program while enrolled in the study. The M Health Fairview DBT program includes weekly individual therapy, group therapy skills development, and access to phone coaching.
The primary focus of the study is safety and tolerability. Participants will be monitored during and after dosing, and adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging experiences, and psychedelic-related side effects will be assessed. Secondary outcomes will evaluate changes in borderline personality disorder symptoms, emotion regulation, depressive symptoms, quality of life, treatment credibility and expectancy, mystical experience, and continued participation in DBT after psilocybin-assisted therapy.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed DSM-5 diagnosis of borderline personality disorder using clinical records and measures used in the M Health Fairview DBT program
- •Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy
- •Age 25 to 65 years
- •Able to speak and understand English
- •Ability to complete all protocol-required assessment tools without assistance or alteration to copyrighted assessments
- •Ability to comply with all study visits
- •Stated willingness to comply with all study procedures and avoid changes to current treatments for the duration of the study
- •If of childbearing potential, use of an acceptable birth control method, including abstinence
排除标准
- •Refusal to give informed consent
- •History of bipolar affective disorder type I or II, schizophrenia, psychosis, delusions, paranoia, schizoaffective disorder, or substance use disorder within the past 12 months
- •First- or second-degree relative with schizophrenia or any other psychotic disorder
- •Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS
- •History of suicide attempt in the last 6 months
- •Comorbid autism
- •Pregnant or may have reason to believe they are pregnant
- •Pre-existing valvular heart disease or pulmonary hypertension
- •Active primary PTSD diagnosis
- •Psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- •Any medical or psychiatric disorder, disease, condition, injury, symptom, or circumstance that may reduce ability to fulfill study requirements, adversely impact data integrity or validity, or pose increased risk during study participation
- •Prisoners
- •Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- •Non-English speakers
- •Individuals unable to read
- •Employees of the researcher
- •Students of the researcher
- •Active members of the military or DoD personnel
研究组 & 干预措施
DBT Plus Psilocybin-Assisted Therapy
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18.
干预措施: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy (Behavioral)
DBT Plus Psilocybin-Assisted Therapy
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Incidence, Severity, and Frequency of Adverse Events
时间窗: Baseline through final study visit at week 18
Safety and tolerability will be assessed by the incidence, severity, and frequency of adverse events, treatment-emergent adverse events, and serious adverse events during the study.
Acute Suicidal Ideation After Psilocybin Dosing
时间窗: Within 24 hours after each dosing visit
Acute suicidal ideation will be assessed after each psilocybin dosing visit using the Modified Scale for Suicidal Ideation and related safety assessments.
Challenging Experiences After Psilocybin Dosing
时间窗: Integration visit 24 hours after each dosing visit
Challenging experiences after psilocybin dosing will be assessed using the Challenging Experiences Questionnaire.
Psilocybin-Related Side Effects
时间窗: Integration visit 24 hours after each dosing visit
Psilocybin-related side effects will be assessed using the Swiss Psychedelic Side Effects Inventory.
Percentage of Participants Who Complete the Study
时间窗: Baseline through final study visit at week 18
Study retention will be assessed as the percentage of enrolled participants who complete the final study visit at week 18. Unit: percentage of participants
Percentage of DBT Therapy Sessions Attended
时间窗: Baseline through final study visit at week 18
Dialectical Behavior Therapy session attendance will be assessed as the percentage of scheduled DBT therapy sessions attended during study participation. Unit: Percentage of sessions
Percentage of Study Assessments Completed
时间窗: Baseline through final study visit at week 18
Assessment completion will be assessed as the percentage of scheduled study assessments completed during study participation. Unit: percentage of assessments
次要结局
- Change in Zanarini Rating Scale Score(Baseline to final study visit at week 18)
- Change in Personality Inventory for DSM-5 Score(Baseline to final study visit at week 18)
- Change in Difficulties in Emotion Regulation Scale-16 Score(Baseline to final study visit at week 18)
- Change in Inventory of Personality Organization Score(Baseline to final study visit at week 18)
- Change in Montgomery-Asberg Depression Rating Scale Score(Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit)
- Change in Quick Inventory of Depressive Symptomatology Score(Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form Score(Baseline to final study visit at week 18)
- Credibility and Expectancy Questionnaire Credibility Score(Day before first dosing and day before second dosing)
- Credibility and Expectancy Questionnaire Expectancy Score(Day before first dosing and day before second dosing)
- Mystical Experience After Psilocybin Dosing(Integration visit immediately after each dosing visit)
- Rate of Continued Participation in Dialectical Behavior Therapy(Through final study visit at week 18)