Alcohol AbuseI-A-CRANCT04381533
Internet-based A-CRA for Young Adults With Problematic Alcohol Use
A study testing Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) and Psychoeducation, information on use of alcohol and its effects in people with Alcohol Abuse and Binge Drinking, run by Nitya Jayaram-Lindstrom at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Abuse, Binge Drinking, Alcohol Use Disorder
- What is being tested?
- Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) and Psychoeducation, information on use of alcohol and its effects
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 11 Feb 2022to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
eStod, Maria Ungdom, Stockholm Centre for Dependency Disorders
Stockholm
Kerstin Annerborn, 08 123 475 04 ext. +46, kersin.annerborn@sll.se
Philip Lindner, Ph.D., 08 123 475 08 ext. +46, philip.lindner@ki.se
About this study
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
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
- Being tested
- Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA), Psychoeducation, information on use of alcohol and its effects
- Keywords
- Randomized Controlled Trial, Alcohol, Internet-delivered Psychological Treatment, Behavior Therapy, Young Adults
- Medical subject headings
- Alcoholism, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)Behavioural
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, information on use of alcohol and its effectsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation, information on use of alcohol and its effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Outcome used to assess feasibility.
Measured: 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.
Measured: 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
Number of self-reported activities registered that are not related to alcohol consumption over the past week. More episodes is a better outcome.
Measured: 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
Self-reported screening of alcohol use disorder symptoms. Higher scores indicate worse outcome. Scores range from 0-40.
Measured: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
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.
Measured: 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
Self-report scale measuring symptoms of depression, anxiety and stress over the past week. Higher scores indicates worse outcome. Scores range from 0-42.
Measured: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start11 Feb 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitya Jayaram-Lindstrom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nitya Jayaram-Lindstrom, Karolinska Institutet
- Investigators
- Nitya Jayaram-Lindstrom, Ph.D., Principal investigator, Department of Clinical Neuroscience, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381533
- Sponsor's protocol ID
- 2018/1264-31/5
- Acronym
- I-A-CRA
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in accordance with institutional guidelines at the Karolinska Institutet, Stockholm, Sweden.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04381533
- Acronym / sponsor ID
- I-A-CRA / 2018/1264-31/5
- Conditions
- Alcohol Abuse, Binge Drinking, Alcohol Use Disorder
- Keywords
- Randomized Controlled Trial, Alcohol, Internet-delivered Psychological Treatment, Behavior Therapy, Young Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nitya Jayaram-LindstromUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-A-CRA | Experimental | Behavioral: Internet-delivered Adolescent Community Reinforcement Approach (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. |
| Psychoeducation alcohol use | Active comparator | Behavioral: Psychoeducation, information on use of alcohol and its effectsPsychoeducation 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | I-A-CRA |
| Psychoeducation, information on use of alcohol and its effectsThe 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. | Behavioural | Psychoeducation alcohol use |
Primary outcome
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment
Time frame: Will be assessed post treatment (11 weeks after treatment initiation)
Outcome used to assess feasibility.
Client Satisfaction Questionnaire 8 item
Time frame: Will be assessed post treatment (11 weeks after treatment initiation)
Acceptance will be measured as percentage of participants rating their satisfaction as good. Higher score indicates better outcome. Scores range from 8-32.
5 secondary outcomes
Timeline Follow-back - change in time spent doing activities unrelated to drinking
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)
Alcohol Use Disorders Identification Test - change pre to post treatment
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Difficulties in Emotion Regulation Scale 16 item - change over timepoints
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)
Depression Anxiety Stress Scale-21 - change pre to post treatment
Time frame: Will be assessed before treatment initiation and post treatment (11 weeks after treatment initiation)
Timeline Follow-back - change in self-rated alcohol consumption
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared in accordance with institutional guidelines at the Karolinska Institutet, Stockholm, Sweden.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitya Jayaram-Lindstrom, Ph.D. principal investigator
Department of Clinical Neuroscience, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) and Psychoeducation, information on use of alcohol and its effects in people with Alcohol Abuse and Binge Drinking, run by Nitya Jayaram-Lindstrom at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria E AAbonde Garke, M.Sc. (70 285 96 14 ext. +46, maria.garke@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treatment completers defined as patients completing 5 or more of the 8 modules of treatment (time frame: Will be assessed post treatment (11 weeks after treatment initiation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.