Internet-based A-CRA for Young Adults With Problematic Alcohol Use (I-A-CRA)

Nitya Jayaram-Lindstrom

Status: Unknown

Conditions: Alcohol Abuse; Alcohol Use Disorder; Binge Drinking

Treatments: Behavioral: Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA); Behavioral: Psychoeducation, information on use of alcohol and its effects

Study type: Interventional

Funder types: Other

Identifiers

NCT04381533

2018/1264-31/5

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

I-A-CRA

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)

Psychoeducation alcohol use

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation, information on use of alcohol and its effects