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

NCT ID: NCT04381533

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2022-09-30

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).

Conditions

Alcohol Abuse; Binge Drinking; Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

The intervention is a behavioral internet-based intervention based on the Adolescent Community Reinforcement Approach. The program encompasses text, pictures, videos, and written as well as practical assignments (skills training). The main components of the treatment for the young adult with problematic alcohol use consist of psychoeducation and functional analysis, goal formulation, increasing prosocial behaviors, relapse prevention, problem solving, and communication training. The accompanying significant other receives modules containing information focusing on gaining an understanding of the treatment components aimed at the young adult, as well as communication training to improve communication between the young adult and the significant other.

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.

Group Type: ACTIVE_COMPARATOR

Psychoeducation, information on use of alcohol and its effects

Intervention Type: BEHAVIORAL

The intervention is a behavioural internet-based intervention including psychoeducation focusing on providing information on alcohol, alcohol use, and its effects. The psychoeducation is provided via texts and pictures, and there is a possibility of asking questions to a therapist if needed however no therapist contact is mandatory. There are separate programs directed towards the young adult and the accompanying significant other. The programmes give brief self-help tips at the end. The intervention approximately corresponds to the information given in a primary care setting for someone with problematic alcohol use.

Interventions

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

The intervention is a behavioral internet-based intervention based on the Adolescent Community Reinforcement Approach. The program encompasses text, pictures, videos, and written as well as practical assignments (skills training). The main components of the treatment for the young adult with problematic alcohol use consist of psychoeducation and functional analysis, goal formulation, increasing prosocial behaviors, relapse prevention, problem solving, and communication training. The accompanying significant other receives modules containing information focusing on gaining an understanding of the treatment components aimed at the young adult, as well as communication training to improve communication between the young adult and the significant other.

Intervention Type: BEHAVIORAL

Psychoeducation, information on use of alcohol and its effects

The intervention is a behavioural internet-based intervention including psychoeducation focusing on providing information on alcohol, alcohol use, and its effects. The psychoeducation is provided via texts and pictures, and there is a possibility of asking questions to a therapist if needed however no therapist contact is mandatory. There are separate programs directed towards the young adult and the accompanying significant other. The programmes give brief self-help tips at the end. The intervention approximately corresponds to the information given in a primary care setting for someone with problematic alcohol use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitya Jayaram-Lindstrom

OTHER

Sponsor Role: lead

Responsible Party

Nitya Jayaram-Lindstrom

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nitya Jayaram-Lindstrom, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Neuroscience, Karolinska Institutet

Locations

eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Maria E AAbonde Garke, M.Sc.

Role: CONTACT

maria.garke@ki.se

70 285 96 14 ext. +46

Simon Jangard, M.Sc.

Role: CONTACT

simon.jangard@ki.se

70 293 59 80 ext. +46

Facility Contacts

Kerstin Annerborn

Role: primary

kersin.annerborn@sll.se

08 123 475 04 ext. +46

Philip Lindner, Ph.D.

Role: backup

philip.lindner@ki.se

08 123 475 08 ext. +46

Other Identifiers

2018/1264-31/5

Identifier Type: -

Identifier Source: org_study_id