The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use

PredictWatch

Status: Enrolling

Conditions: Addiction, Alcohol; Addiction; Addiction, Substance

Treatments: Other: mobile app

Study type: Interventional

Funder types: Industry

Identifiers

NCT05434416

2022/001A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 13 patient groups

No Interventions

No Intervention group

Description:

Given access to all interventions at the end of the 5 weeks of the trial.

Short-term interventions

Experimental group

Description:

Participants have access only to short-term interventions. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Short-term and long-term interventions

Experimental group

Description:

Short-term and long-term interventions Participants have access to short-term and all long-term interventions.

Treatment:

Other: mobile app

Long-term intervention: Meditations

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Meditations. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Mindfulness

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Mindfulness. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: My beliefs

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: My beliefs. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Success Diary

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Success Diary. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Gratitude Journal

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Gratitude Journal. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Planner

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Planner. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Journey to Sobriety

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Journey to Sobriety. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Mood Journal

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Mood Journal. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Dream Diary

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Dream Diary. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app

Long-term intervention: Thinking traps

Experimental group

Description:

Participants have access to short-term interventions. Participants have access to one long-term intervention: Thinking traps. Given access to all interventions at the end of the 5 weeks of the trial.

Treatment:

Other: mobile app