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

NCT04381533 | Unknown

• 1 other identifier: 2018/1264-31/5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized Controlled Trial; Alcohol; Internet-delivered Psychological Treatment; Behavior Therapy; Young Adults

Outcome Measures

Primary Outcomes (2)

• Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment

  Outcome used to assess feasibility.

  Will be assessed post treatment (11 weeks after treatment initiation)

• Client Satisfaction Questionnaire 8 item

  Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.

  Will be assessed post treatment (11 weeks after treatment initiation)

Secondary Outcomes (5)

• 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)

• Alcohol Use Disorders Identification Test - change pre to post treatment

  Will be assessed before treatment initiation 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)

• 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)

Other Outcomes (21)

• Barratt Impulsiveness Scale - change pre to post treatment

  Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)

• Adult ADHD Self-Report Screener - change pre to post treatment

  Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)

• Obsessive Compulsive Drinking Scale - change pre to post treatment

  Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)

Study Arms (2)

I-A-CRA

EXPERIMENTAL

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.

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

Psychoeducation alcohol use

ACTIVE COMPARATOR

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.

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

Interventions

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

I-A-CRA

Psychoeducation, information on use of alcohol and its effects 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.

Psychoeducation alcohol use

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitya Jayaram-Lindstrom: lead

Study Sites (1)

eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Alcoholism; Binge Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol Drinking; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Nitya Jayaram-Lindstrom, Ph.D.

  Department of Clinical Neuroscience, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria E AAbonde Garke, M.Sc.

CONTACT

70 285 96 14; maria.garke@ki.se

Simon Jangard, M.Sc.

CONTACT

70 293 59 80; simon.jangard@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: February 11, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)