Clinical trial NCT05434416: The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
Official title: The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Addiction, Alcohol
Addiction, Substance
Keywords: stimulants
alcohol
mobile app
mHealth
Lead sponsor: PredictWatch
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in users with substance use disorder or problematic substance use (alcohol and stimulants). Participants are randomly assigned to thirteen different groups to compare the effectiveness of particular long-term interventions. A questionnaire battery assessment is administered (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment.

Detailed description: The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in users with substance use disorder or problematic substance use (alcohol and stimulants).

Two main self-guided intervention modules are available. Short-term self-guided intervention module include mainly audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation. Moreover, there based on breath relaxation exercises, craving management, and motivation to change Long-term self-guided intervention module include CBT-based interventions, meditations, mindfulness, and journaling.

Participants are recruited via newsletters, local and nation-wide advertisements, as well as through social media. The study is conducted via a mobile application "Nałogometr", freely available to participants. We recruit people from the general population residing in Poland.

To compare the effectiveness of mobile app-based self-guided psychological interventions, participants are randomly assigned to thirteen different groups.

Experimental conditions are balanced based on multiple variables provided during onboarding: (1) main addiction type; (2) participation in addiction-related therapy; (3) gender; (4) age; (5) addiction severity; (6) abstinence duration.

In groups 1-10, participants have access to short-term interventions and one of the long-term interventions. Participants assigned to group 11 have access to short-term and all long-term interventions. Participants in group 12 have access only to short-term interventions. Finally, participants assigned to group 13 serve as the control group and only have access to the weekly ecological momentary assessment reports. However, the control group will be granted access to all intervention materials after five weeks following study enrollment. Participants in group 1-12 will be able to access the intervention materials 5 days after enrollment and will receive weekly ecological momentary assessment reports.

Questionnaire battery assessments will take place: (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk will be collected daily using ecological momentary assessment.

Eligibility criteria: Inclusion Criteria:

* are at least 18 years of age
* speak Polish fluently
* use either an Android or iOS smartphone

Exclusion Criteria:

-

Primary outcomes:
measure: Lapses rate according to EMA self-report
timeFrame: 5 weeks
measure: Craving level according to EMA self-report
timeFrame: 5 weeks
Secondary outcomes:
measure: Score of Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 1 week, 5 weeks, 6 months
measure: Score of Severity of Dependence Scale (SDS)
timeFrame: 1 week, 5 weeks, 6 months
measure: Score of Satisfaction With Life Scale (SWLS)
timeFrame: 1 week, 5 weeks, 6 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: PredictWatch
Study officials:
References: