Internet-based Adolescent Community Reinforcement Approach (I-A-CRA) With Therapist Support for Young Adults With Problematic Alcohol Use: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
研究概览
简要总结
The primary aim of the study is to evaluate the feasibility and acceptability of an internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) with therapist support for young adults (aged 18-24 years) with problematic alcohol use and their caregiver/significant other. Secondary aims include investigating the role of comorbid emotional symptoms, emotion regulation and prosocial behavior in treatment outcomes for the young adults. In a randomized controlled pilot trial, participants (n = 60 young adults as well as an optional accompanying caregiver/significant other) will be recruited from the community through advertisements as well as through clinic referrals in Stockholm, Sweden. Eligible participants will be randomized either to the 10-week I-A-CRA treatment or to an active control group (receiving psychoeducation about alcohol use over the same time frame). In both conditions an optionally accompanying caregiver/significant other will receive a support program in conjunction with the young adult's treatment. Participating young adults will be evaluated with regards to their alcohol use, psychiatric symptoms, emotion regulation, and prosocial behavior at pre-treatment, weekly during treatment, post-treatment, and at a 3-month follow-up. The primary outcome will be feasibility (measured as number of treatment completers; i.e., having completed 5 out of 8 treatment modules), and acceptability (measured by patient satisfaction). Secondary outcomes will include pre- and post-treatment self-rated binge drinking episodes, levels of depression, anxiety and stress, emotion dysregulation, and prosocial behavior. Self-reports regarding stress, emotion dysregulation, and prosocial behavior will be complemented by behavioral measures (computerized tasks).
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 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adult between 18-24 years of age
- •Reporting ongoing substance use (alcohol), heavy drinking measured as risky use according to recommendations: 5/4 (male/female) standard drinks on a minimum of two occasions in the last month, or AUDIT-C ≥ 4 points indicating harmful consumption
- •Access to internet via computer or other similar device, as well as access to smartphone
- •If on psychiatric medication, it should have been a stable dosage during the past 3 months prior to pre-treatment assessment
- •Adequate knowledge in the Swedish language and a Swedish personal identification number
排除标准
- •Current DSM-5 diagnosis for any other substance use disorder except nicotine dependence
- •Current (including last 12 months) DSM-5 diagnosis for other major psychiatric disorder (bipolar disorder, psychosis)
- •Recent initiation of psychiatric medication or psychotherapy (within the last 3 months)
- •Suicidal ideation at screening
- •Serious somatic diagnosis requiring medical attention, such as uncontrolled diabetes mellitus, epilepsy or heart conditions
- •Traces of any psychoactive substance (e.g., central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample at baseline assessment
- •Pregnancy
研究组 & 干预措施
I-A-CRA
Internet-delivered Adolescent Community Reinforcement Approach: The treatment program consists of 8 extensive treatment modules delivered over 10 weeks with continuous therapist support and guidance. There are two separate treatments for the young adult and the caregiver/significant other.
干预措施: Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) (Behavioral)
Psychoeducation alcohol use
Psychoeducation focusing on alcohol use: This support program provides 8 brief modules of psychoeducation (alcohol information) over 10 weeks. Participants receive no therapist guidance/support but have the possibility of asking questions to a therapist. There are two separate programs for the young adult and the caregiver/significant other.
干预措施: Psychoeducation, information on use of alcohol and its effects (Behavioral)
结局指标
主要结局
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
时间窗: Will be assessed post treatment (11 weeks after treatment initiation)
Outcome used to assess feasibility.
Client Satisfaction Questionnaire 8 item
时间窗: Will be assessed post treatment (11 weeks after treatment initiation)
Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.
次要结局
- Depression Anxiety Stress Scale-21 - change pre to post treatment(Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation))
- Timeline Follow-back - change in self-rated alcohol consumption(Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation))
- Timeline Follow-back - change in time spent doing activities unrelated to drinking(Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation))
- Difficulties in Emotion Regulation Scale 16 item - change over timepoints(Will be assessed before treatment initiation, at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment, and post treatment (11 weeks after treatment initiation))
- Alcohol Use Disorders Identification Test - change pre to post treatment(Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation))
研究者
Nitya Jayaram-Lindstrom
Principal Investigator
Karolinska Institutet