Internet-based A-CRA for Young Adults With Problematic Alcohol Use
- Conditions
- Alcohol AbuseBinge DrinkingAlcohol Use Disorder
- Interventions
- Behavioral: Psychoeducation, information on use of alcohol and its effectsBehavioral: Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)
- Registration Number
- NCT04381533
- Lead Sponsor
- Nitya Jayaram-Lindstrom
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychoeducation alcohol use Psychoeducation, information on use of alcohol and its effects 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. I-A-CRA Internet-delivered Adolescent Community Reinforcement Approach (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.
- Primary Outcome Measures
Name Time Method Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment Will be assessed post treatment (11 weeks after treatment initiation) Outcome used to assess feasibility.
Client Satisfaction Questionnaire 8 item 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 Outcome Measures
Name Time Method Depression Anxiety Stress Scale-21 - change pre to post treatment Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation) Self-report scale measuring symptoms of depression, anxiety and stress over the past week. Higher scores indicates worse outcome. Scores range from 0-42.
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) Number of heavy drinking episodes (heavy drinking defined as 4 or more drinks per drinking occasion in women and 5 or more for men) over the past week. Fewer episodes is a better outcome.
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) Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
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) Self-report scale measuring emotion dysregulation. Higher scores indicate worse outcome. Scores range from 16-80.
Alcohol Use Disorders Identification Test - change pre to post treatment Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation) Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Trial Locations
- Locations (1)
eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders
🇸🇪Stockholm, Sweden