Internet-based Adolescent Community Reinforcement Approach (I-A-CRA) With Therapist Support for Young Adults With Problematic Alcohol Use: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Time Frame: Will be assessed post treatment (11 weeks after treatment initiation)
Outcome used to assess feasibility.
Client Satisfaction Questionnaire 8 item
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
Nitya Jayaram-Lindstrom
Principal Investigator
Karolinska Institutet