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

Primary Purpose

Alcohol Abuse, Binge Drinking, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)
Psychoeducation, information on use of alcohol and its effects
Sponsored by
Nitya Jayaram-Lindstrom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Randomized Controlled Trial, Alcohol, Internet-delivered Psychological Treatment, Behavior Therapy, Young Adults

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • eStod, Maria Ungdom, Stockholm Centre for Dependency DisordersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I-A-CRA

Psychoeducation alcohol use

Arm 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.

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.

Outcomes

Primary Outcome Measures

Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Outcome used to assess feasibility.
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.

Secondary Outcome Measures

Timeline Follow-back - change in time spent doing activities unrelated to drinking
Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
Alcohol Use Disorders Identification Test - change pre to post treatment
Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Difficulties in Emotion Regulation Scale 16 item - change over timepoints
Self-report scale measuring emotion dysregulation. Higher scores indicate worse outcome. Scores range from 16-80.
Depression Anxiety Stress Scale-21 - change pre to post treatment
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
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.

Full Information

First Posted
April 28, 2020
Last Updated
March 29, 2022
Sponsor
Nitya Jayaram-Lindstrom
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1. Study Identification

Unique Protocol Identification Number
NCT04381533
Brief Title
Internet-based A-CRA for Young Adults With Problematic Alcohol Use
Acronym
I-A-CRA
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nitya Jayaram-Lindstrom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Binge Drinking, Alcohol Use Disorder
Keywords
Randomized Controlled Trial, Alcohol, Internet-delivered Psychological Treatment, Behavior Therapy, Young Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I-A-CRA
Arm Type
Experimental
Arm 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.
Arm Title
Psychoeducation alcohol use
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)
Intervention Description
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
Intervention Name(s)
Psychoeducation, information on use of alcohol and its effects
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Description
Outcome used to assess feasibility.
Time Frame
Will be assessed post treatment (11 weeks after treatment initiation)
Title
Client Satisfaction Questionnaire 8 item
Description
Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.
Time Frame
Will be assessed post treatment (11 weeks after treatment initiation)
Secondary Outcome Measure Information:
Title
Timeline Follow-back - change in time spent doing activities unrelated to drinking
Description
Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
Time Frame
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)
Title
Alcohol Use Disorders Identification Test - change pre to post treatment
Description
Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Difficulties in Emotion Regulation Scale 16 item - change over timepoints
Description
Self-report scale measuring emotion dysregulation. Higher scores indicate worse outcome. Scores range from 16-80.
Time Frame
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)
Title
Depression Anxiety Stress Scale-21 - change pre to post treatment
Description
Self-report scale measuring symptoms of depression, anxiety and stress over the past week. Higher scores indicates worse outcome. Scores range from 0-42.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Timeline Follow-back - change in self-rated alcohol consumption
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Barratt Impulsiveness Scale - change pre to post treatment
Description
Self-report scale measuring behavioral impulsivity. Higher scores indicates worse outcome. Scores range from 30-120.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Adult ADHD Self-Report Screener - change pre to post treatment
Description
Self-report scale measuring ADHD symptoms. Higher score indicates worse outcome.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Obsessive Compulsive Drinking Scale - change pre to post treatment
Description
Self-report scale measuring compulsive drinking.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Pro-social behavior - change pre to post treatment
Description
Computerized experimental behavior tasks measuring reward-based pro-social behavior and decision making regarding generous, trustful, reciprocal and compensatory behavior.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Emotion regulation/distress tolerance (Paced Auditory Serial Addition Task) - change pre to post treatment
Description
Computerized behavior task measuring emotion regulation/distress tolerance. A longer time spent doing the task indicates better outcome.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Drinking Motive Questionnaire Revised Short Form - change pre to post treatment
Description
Self-report scale measuring drinking motives.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Drug Use Disorders Identification Test - change pre to post treatment
Description
Self-report screening of any drug use disorder symptoms. Higher score indicates worse outcome. Scores range from 0-44.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Social Interaction Anxiety Scale - change pre to post treatment
Description
Self-report scale measuring symptoms of social anxiety.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Prosocial Tendencies Measure - change pre to post treatment
Description
Self-report scale measuring prosocial behavior.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Oxford Utilitarianism Scale - change pre to post treatment
Description
Self-report scale measuring prosocial behavior.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Questionnaire of Cognitive and Affective Empathy - change pre to post treatment
Description
Self-report scale measuring prosocial behavior (empathy).
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Positive Personality Traits - change pre to post treatment
Description
Self-report scale measuring prosocial behavior (positive personality traits).
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Social Value Orientation - change pre to post treatment
Description
Self-report scale measuring prosocial behavior.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Autism Spectrum Quotient Short Form - change pre to post treatment
Description
Self-report scale measuring symptoms of autism spectrum disorder. Higher scores indicate worse outcome.
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
Positive and Negative Affect Schedule - Negative affect - change pre to post treatment
Description
Self-report scale measuring negative affect in the moment on a 5-point scale (higher score indicates more negative affect).
Time Frame
Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Title
VAS Single Item Craving Question - change over timepoints
Description
Self-report scale measuring craving for alcohol in the moment on a visual analog scale ranging from 0-100 (a higher score indicates more craving).
Time Frame
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)
Title
Significant other, change in rating of drinking in the young adult (with Timeline Follow-back)
Description
Self-report scale measuring alcohol use in the young adult as assessed by significant other in the past week. Higher number of episodes indicates worse outcome.
Time Frame
Will be assessed at week 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of treatment
Title
Socioeconomic and Demographic Questionnaire
Description
Self-report of demographic information.
Time Frame
Will be assessed before treatment initiation
Title
EQ-5D
Description
Self-report scale measuring disability (a higher score indicates worse outcome) and generic health status (rated on a visual analog scale ranging from 0-100 where higher score indicates better outcome).
Time Frame
Will be assessed before treatment initiation
Title
Family Tree Questionnaire
Description
Self-report scale assessing family history of alcohol problems, number of family history-positive and family history-negative relatives.
Time Frame
Will be assessed before treatment initiation
Title
Negative Effects Questionnaire
Description
Self-report scale measuring negative effects associated with psychotherapy. Higher score indicates worse outcome.
Time Frame
Will be assessed post treatment (11 weeks after treatment initiation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria E AAbonde Garke, M.Sc.
Phone
70 285 96 14
Ext
+46
Email
maria.garke@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Jangard, M.Sc.
Phone
70 293 59 80
Ext
+46
Email
simon.jangard@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitya Jayaram-Lindstrom, Ph.D.
Organizational Affiliation
Department of Clinical Neuroscience, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Annerborn
Phone
08 123 475 04
Ext
+46
Email
kersin.annerborn@sll.se
First Name & Middle Initial & Last Name & Degree
Philip Lindner, Ph.D.
Phone
08 123 475 08
Ext
+46
Email
philip.lindner@ki.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared in accordance with institutional guidelines at the Karolinska Institutet, Stockholm, Sweden.

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

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