Clinical trial NCT04381533: Internet-based A-CRA for Young Adults With Problematic Alcohol Use
Official title: Internet-based Adolescent Community Reinforcement Approach (I-A-CRA) With Therapist Support for Young Adults With Problematic Alcohol Use: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Abuse
Binge Drinking
Alcohol Use Disorder
Keywords: Randomized Controlled Trial
Alcohol
Internet-delivered Psychological Treatment
Behavior Therapy
Young Adults
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
timeFrame: Will be assessed post treatment (11 weeks after treatment initiation)
measure: Client Satisfaction Questionnaire 8 item
timeFrame: Will be assessed post treatment (11 weeks after treatment initiation)
Secondary outcomes:
measure: Timeline Follow-back - change in time spent doing activities unrelated to drinking
timeFrame: 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)
measure: Alcohol Use Disorders Identification Test - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Difficulties in Emotion Regulation Scale 16 item - change over timepoints
timeFrame: 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)
measure: Depression Anxiety Stress Scale-21 - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Timeline Follow-back - change in self-rated alcohol consumption
timeFrame: 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:
measure: Barratt Impulsiveness Scale - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Adult ADHD Self-Report Screener - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Obsessive Compulsive Drinking Scale - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Pro-social behavior - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Emotion regulation/distress tolerance (Paced Auditory Serial Addition Task) - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Drinking Motive Questionnaire Revised Short Form - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Drug Use Disorders Identification Test - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Social Interaction Anxiety Scale - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Prosocial Tendencies Measure - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Oxford Utilitarianism Scale - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Questionnaire of Cognitive and Affective Empathy - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Positive Personality Traits - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Social Value Orientation - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Autism Spectrum Quotient Short Form - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: Positive and Negative Affect Schedule - Negative affect - change pre to post treatment
timeFrame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
measure: VAS Single Item Craving Question - change over timepoints
timeFrame: 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)
measure: Significant other, change in rating of drinking in the young adult (with Timeline Follow-back)
timeFrame: Will be assessed at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment
measure: Socioeconomic and Demographic Questionnaire
timeFrame: Will be assessed before treatment initiation
measure: EQ-5D
timeFrame: Will be assessed before treatment initiation
measure: Family Tree Questionnaire
timeFrame: Will be assessed before treatment initiation
measure: Negative Effects Questionnaire
timeFrame: Will be assessed post treatment (11 weeks after treatment initiation)
Locations:
city: Stockholm
country: Sweden
facility: eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders
Study officials:
affiliation: Department of Clinical Neuroscience, Karolinska Institutet
name: Nitya Jayaram-Lindstrom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: