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

NCT ID: NCT05434416

Last Updated: 2022-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2023-02-28

Brief Summary

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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

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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 "NaƂogometr", 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.

Conditions

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Addiction Addiction, Alcohol Addiction, Substance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No Interventions

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Short-term interventions

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

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Short-term and long-term interventions

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

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Meditations

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Mindfulness

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: My beliefs

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Success Diary

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Gratitude Journal

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Planner

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Journey to Sobriety

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Mood Journal

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Dream Diary

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Long-term intervention: Thinking traps

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.

Group Type EXPERIMENTAL

mobile app

Intervention Type OTHER

mobile app self-guided psychological interventions

Interventions

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mobile app

mobile app self-guided psychological interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PredictWatch

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PredictWatch

Bialystok, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Alicja Binkowska, PhD

Role: CONTACT

Maciej Skorko

Role: CONTACT

048792230523

Facility Contacts

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Alicja A Binkowska, PhD

Role: primary

Maciej Skorko

Role: backup

+48792230523

Other Identifiers

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2022/001A

Identifier Type: -

Identifier Source: org_study_id

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