Testing an aftercare mobile application for relapse prevention to alcohol and cannabis use among young adults

ISRCTN	ISRCTN74552565
DOI	https://doi.org/10.1186/ISRCTN74552565

Submission date: 30/11/2022
Registration date: 06/12/2022
Last edited: 06/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Alcohol and illicit drugs constitute massive health and societal problems among young adults in Denmark, but treatment is challenged by low rates of enrollment and engagement and high rates of relapse. Mobile apps may support treatment engagement and help young adults cope with high-risk situations related to relapse. Studies are needed that involve clients and researchers with technical knowledge.

Who can participate?
Young adults aged 18-30 years old enrolled in substance use disorder (SUD) treatment

What does the study involve?
Researchers will test the app among participants who meet the study intake criteria and provide informed study consent. They will be randomly assigned to “Immediate App Access” or “Delayed App Access”. Both groups will be assessed at 6- and 12-week follow-ups. The focus will be on whether the app will prevent relapse to problematic use.

What are the possible benefits and risks of participating?
Study participation has the potential to increase client empowerment and does not have negative side effects.

Where is the study run from?
Aarhus University (Denmark)

When is the study starting and how long is it expected to run for?
January 2021 to December 2023

Who is funding the study?
1. Trygfonden (Denmark)
2. Helsefonden (Denmark)
3. Centre for Alcohol and Drug Research and Orbit Lab, Aarhus University (Denmark)

Who is the main contact?
Birgitte Thylstrup, bt.crf@psy.au.dk (Denmark)
Adriana del Palacio-Gonzalez, apg.crf@psy.au.dk (Denmark)

Study website

Contact information

Dr Birgitte Thylstrup
Principal Investigator

Aarhus University
DPU, Campus Emdrup
Centre for Alcohol and Drug Research
Tuborgvej 164, building A, 2nd floor
Copenhagen
2400
Denmark

ORCID ID	0000-0001-5658-5392
Phone	+45 21587881
Email	bt.crf@psy.au.dk

Dr Adriana Palacio-Gonzalez
Scientific

Aarhus University
Centre for Alcohol and Drug Research
Bartholins Allé 10
Aarhus
8000
Denmark

ORCID ID	0000-0002-6523-4639
Phone	+45 26343648
Email	apg.crf@psy.au.dk

Study information

Study design	Multicentre randomized pilot study with follow-up
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Prevention
Participant information sheet	Not available in web format and English, please use contact details to request a translated participant information sheet.
Scientific title	Pilot testing an aftercare mobile application for relapse prevention to alcohol and cannabis use among young adults: protocol of a feasibility and randomized pilot study
Study acronym	MARPAC
Study objectives	Study hypotheses has two foci 1) the clinical effect of the mobile app (AfterCare) that is tested, 2) regarding feasibility and usability of the app. Clinical effect: Compared to study participants randomized to 6 weeks later access to the mobile app, study participants randomized to immediate access to the mobile app will report fewer days of alcohol and/or cannabis use in the follow-up assessments after controlling for their substance use at baseline. Hypothesis #1: Study participants who gain immediate access to the mobile app will report fewer days of cannabis and/or alcohol use in the prior 7 days compared to study participants who gain access to the mobile app 6 weeks later. Hypothesis#2: Study participants who gain immediate access to the mobile app will report fewer days of cannabis and/or alcohol use in the last month compared to study participants who gain access to the mobile app 6 weeks later. Feasibility and usability: We expect to find variations among study participants in both study conditions in regards with frequency and preference of the app functions. Hypothesis#1: Study participants who gain immediate access to the mobile app will use it more than study participants who gain access to the mobile app 6 weeks later. Hypothesis#2: Study participants who use the specific functions in the mobile app independently (e. g., personalizing the app by entering personalized data in strategies, calendar, or high-risk situations) within the first week after they gain access to the mobile app will be more likely to continue using the app compared to study participants who don’t use the specific functions functions in the app.
Ethics approval(s)	Approved 08/11/2022, Scientific Ethics Committee – Region Mid-Jutland [De Videnskabsetiske Komitéer For Region Midtjylland] (Skottenborg 26, 8800 Viborg, Denmark; +45 78410189; komite@rm.dk), ref: 1-10-72-110-22
Health condition(s) or problem(s) studied	Alcohol, cannabis, and other illegal drug substance use disorder
Intervention	The aim of the study is to assess the feasibility of using the final version of the AfterCare app in clinical contexts, and to obtain preliminary data on clinical effectiveness for preventing relapse to substance use. The study will test the AfterCare app as an add-on to outpatient treatment. Study participants will be newly enrolled patients who are deemed eligble for study participation. All study participants will receive treatment as usual and go through the same procedures at the participating treatment centers. These procedures include intake assessment and screening (using the Danish monitoring system MapPlan), study recruitment, and randomization to one of the two conditions. The two conditions are the Immediate App Use (IAU; n = 45) and the Delayed App Use (DAU; n = 45) conditions. In the IAU condition, study participants will gain full access to the app the same day that the app is installed on the mobile phone at the third treatment session and for the next 12 weeks. In the DAU condition, study participants gain access to the installed app 6 weeks after the third treatment session and for the next 6 weeks. Thus, during the first 6 weeks after the third treatment sessions, the DAU will function as a control condition. Block randomization will be used to allocate eligible patients to one of the two treatment conditions. The blocks will be based on seven variables: sex, age, prior treatment for substance use disorder, having a diagnosis for a psychological disorders, frequency of binge drinking in the last month, cannabis use days in the last month, and use of other illicit drugs. The information will be collected online at the site by practitioners involved in the study and sent to the researchers on a secure server
Intervention type	Behavioural
Primary outcome measure	Clinical effect: 1. Seven-day alcohol use measured using the Time Line Follow Back questionnaire (TLFB), at baseline, and 6, and 12-week follow-ups 2. Thirty-day alcohol use measured using a single-item question (How many days have you drank alcohol in the last month?), at baseline, and 6, and 12-week follow-ups 3. Seven-day cannabis use measured using the Time Line Follow Back questionnaire (TLFB), at baseline, and 6, and 12-week follow-ups 4. Thirty-day cannabis use measured using a single-item question (How many days have you used any cannabis products in the last month?), at baseline, and 6, and 12-week follow-ups Feasibility and usability: Average use of app measured using the number of clicks on different app functions in the first 6 weeks of use
Secondary outcome measures	1. Seven-day illicit drug use measured using a single-item question (How many days have you used any illicit drugs, except for cannabis, in the last 7 days?), at baseline, and 6, and 12-week follow-ups 2. Thirty-day illicit drug use measured using a single item question (How many days have you used any illicit drugs, except for cannabis, in the last month), at baseline, and 6, and 12-week follow-ups 3. Depressive symptoms in the last 2 weeks measured using the Patient Health Questionnaire-2 (PHQ-2) and anxiety symptoms in the last 2 weeks measured using the Generalized Anxiety Disorder 2-item (GAD-2), at baseline, and 6, and 12-week follow-ups
Overall study start date	01/01/2021
Completion date	01/12/2023

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	90
Key inclusion criteria	1. Aged 18 – 30 years old 2. Own a mobile with a data plan 3. Enrolling in outpatient treatment for alcohol or cannabis use at one of the participating sites 4. Provision of informed consent to study participation 5. Attends the third treatment session after enrollment in treatment for the provision of the app
Key exclusion criteria	1. Severe mental illness (e.g., psychosis) or dangerous behavior (e.g., aggression) 2. Severe neuropsychological disorder or cognitive dysfunction 3. Not willing or able to give informed consent to participate in the study 4. Does not speak or understand Danish in a way that makes it possible to participate in the project 5. Took part in a prior stage of the project that focused on the app development
Date of first enrolment	01/12/2022
Date of final enrolment	01/10/2023

Locations

Countries of recruitment

Denmark

Study participating centres

Brydehuset Rusmiddelbehandling

Brydehusvej 12
Ballerup
2750
Denmark

KABS City, Ambulant behandling med fokus på stofmisbrug

Kirsten Walthers Vej 2, 2nd floor
Valby
2500
Denmark

CAS - Center for Alkohol- og Stofbehandling

Ringstedgade no14, 16, and 22
Roskilde
4000
Denmark

Rusmiddelrådgivning Horsens Kommune

Vesterled 1
Horsens
8700
Denmark

Sponsor information

Aarhus University
University/education

Centre for Alcohol and Drug Research
Bartholins Allé 10
Aarhus
8000
Denmark

Phone	+45 8716 5313
Email	crf@au.dk
Website	https://psy.au.dk/en/research/research-centres-and-units/centre-for-alcohol-and-drug-research
"ROR"	https://ror.org/01aj84f44

Funders

Funder type

Research organisation

TrygFonden
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Tryg Foundation
Location: Denmark

Helsefonden
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Health Foundation
Location: Denmark

Aarhus Universitet
Government organisation / Universities (academic only)

Alternative name(s): Aarhus University, Universitas Arhusiensis, AU
Location: Denmark

Results and Publications

Intention to publish date	01/07/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Not expected to be made available
Publication and dissemination plan	Positive, negative, and inconclusive results of the studies will be published in international scientific journals. The findings, irrespective of their conclusions, will be disseminated through other outlets both scientific, clinical, and with the lay-person, such as open-access local reports, conferences, and meetings with local research networks and clinical centers. We expect minimum 2 scientific articles deriving for this project.
IPD sharing plan	We prepared a consent form that would increase trust and engagement with the target population concerning data collection, and thus stated that the collected data is only sharable among members of the research group.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 2.0	14/09/2022	06/12/2022	No	No

Additional files

42838 Protocol v2.0 14Sept2022.pdf

Editorial Notes

06/12/2022: Trial's existence confirmed by the Scientific Ethics Committee – Region Mid-Jutland.