Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Feasibility of Adding UP Group Intervention to TAU
研究概览
简要总结
The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.
详细描述
Young adults with substance use disorder (SUD) commonly experience co-occurring emotional distress in the form of affective/emotional disorders (i.e. anxiety, depressive, and related disorders) and self-injurious thoughts and behaviors (SITBs). Based on the conceptualization of emotion dysregulation as a transdiagnostic treatment target, the current study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to target core psychopathological processes related to emotion dysregulation that underlie SITBs and emotional disorder pathology. Given its transdiagnostic format, the UP has the potential to address comorbidity among the emotional disorders (and other functionally similar problems such as SUDs) simultaneously and more comprehensively than single-diagnosis treatments.
Patients seeking services or currently engaged in care at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders (the MGH Addiction Recovery Management Service) are eligible for this study. Participants will be randomized 2:1 to receive either UP + TAU or TAU alone. The adjunctive UP intervention consists of 16 twice-weekly group sessions (delivered over an 8-week period) designed to deliver transdiagnostic, emotion-focused CBT strategies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients seeking services or currently engaged in care at the MGH Addiction Recovery Management Service are eligible for this study.
- •Inclusion Criteria:
- •Young adults ages 18 to 26, inclusive
- •English language proficiency
- •Ability to provide written, informed consent
- •Ability to attend in-person, outpatient sessions
- •Has provided consent to receive or is currently undergoing treatment at the MGH Addiction Recovery Management Service
- •Documented DSM-5 SUD diagnosis (limited to alcohol use disorder; cannabis use disorder; phencyclidine or other hallucinogen use disorder; inhalant use disorder, opioid use disorder; sedative, hypnotic, or anxiolytic use disorder; stimulant use disorder; other (or unknown) SUD)
- •Current elevated emotional distress, as evidenced by any one of the following:
- •Score at least in the moderate range on self-report anxiety questionnaire
- •Score at least in the moderate range on self-report depression questionnaire
- •Report of suicidal thoughts in the past week
- •Report of engagement in non-suicidal self-injury in the past week
- •Not expected to require inpatient level of care within the next two weeks (as judged clinically)
排除标准
- •Documented psychotic disorder (or current, clinically significant psychotic symptoms) that render the patient inappropriate for outpatient level of care or participation in group therapy (as judged clinically by study staff)
- •Current imminent suicide or homicide risk (as judged clinically by study staff)
- •Unwilling or unable to provide consent for study staff to access subject's medical records and coordinate care and exchange data with clinical staff at the Addiction Recovery Management Service
- •Unwilling or unable to identify an emergency contact
研究组 & 干预措施
Unified Protocol + Treatment As Usual
Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
干预措施: Unified Protocol (UP) (Behavioral)
Treatment As Usual Alone
Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
干预措施: Treatment as Usual (TAU) (Other)
Unified Protocol + Treatment As Usual
Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Feasibility of Adding UP Group Intervention to TAU
时间窗: 8-week treatment period
Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition.
Acceptability of Adding UP Group Intervention to TAU
时间窗: At the end of the 8-week treatment period
Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received.
次要结局
- Substance Craving(At the end of the 8-week treatment period)
- Percentage of Past 30 Days Abstinent From Substances(At the end of the 8-week treatment period)
- Depressive Symptoms Scale (ODSIS)(At the end of the 8-week treatment period)
- Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month(At the end of the 8-week treatment period)
- Suicidal Ideation(At the end of the 8-week treatment period)
- Commitment to Sobriety(At the end of the 8-week treatment period)
- OASIS(At the end of the 8-week treatment period)
研究者
Kate Bentley, PhD
Assistant Professor, Harvard Medical School
Massachusetts General Hospital