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

Sponsor
PredictWatch (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05434416
Collaborator
(none)
600
1
13
7.4
81.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mobile app
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
Actual Study Start Date :
Jun 21, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Interventions

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

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: Short-term and long-term interventions

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

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Experimental: 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.

Other: mobile app
mobile app self-guided psychological interventions

Outcome Measures

Primary Outcome Measures

  1. Lapses rate according to EMA self-report [5 weeks]

    collected daily via the participant's smartphone; an item asking whether or not the lapse occurred since the last survey (yes / no). The score will be tracked for changes over time.

  2. Craving level according to EMA self-report [5 weeks]

    collected daily via the participant's smartphone; an item asking how strong is one's urge to use [substance] at the moment on a scale of 0 to 6 (none - incalculable ). The score will be tracked for changes over time.

Secondary Outcome Measures

  1. Score of Alcohol Use Disorders Identification Test (AUDIT) [1 week, 5 weeks, 6 months]

    Problematic alcohol use will be masured with an Alcohol Use Disorders Identification Test (AUDIT) (WHO, 2001), a 10-item one-dimensional tool. Participant's answer the questions in terms of standard drinks. AUDIT assesses the amount and frequency of alcohol intake (items 1-3), alcohol dependence (questions 4-6), and problems related to alcohol consumption (items 7-10). Questions 1 to 8 are scored on a 5-point scale ranging from 0 to 4, and questions 9 and 10 are scored as 0, 2, or 4. Total scores range from 0 to 40, and the cut-off point to identify hazardous alcohol intake is 8, a score between 16 and 19 indicates harmful alcohol use, and scores above 20 points indicate possible alcohol use disorder.

  2. Score of Severity of Dependence Scale (SDS) [1 week, 5 weeks, 6 months]

    The Severity of Dependence Scale (SDS) (Gossop, et al., 1995) will be used to provide a self-reported measure of psychological aspects of stimulants and alcohol dependence. A five-items, one-dimensional tool has uniform scale for questions 1 - 4 from 0 ('never or almost never') to 3 ('always'). Question 5 has the same scale with different signature where 0 means 'not difficult at all' and 3 means 'impossible'. Score ranging from 0 to 15, where cut-off score depends on user's drug type - a cut-off of =< 3 has been used for indexing alcohol dependence (Lawrinson et al., 2007) and =< 5 for indexing amphetamine dependence (Topp & Mattick, 1997).

  3. Score of Satisfaction With Life Scale (SWLS) [1 week, 5 weeks, 6 months]

    Participants' satisfaction with their life will be assessed with The Satisfaction With Life Scale (SWLS) (Diener et al., 1985), Polish version from Jankowski (2015). SWLS is a short self-report instrument on which participants indicate their agreement to five statements about life satisfaction on a seven-point Likert scale. A maximum score of 35 can be reached, indicating a high level of life satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • are at least 18 years of age

  • speak Polish fluently

  • use either an Android or iOS smartphone

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 PredictWatch Białystok Poland 15-668

Sponsors and Collaborators

  • PredictWatch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
PredictWatch
ClinicalTrials.gov Identifier:
NCT05434416
Other Study ID Numbers:
  • 2022/001A
First Posted:
Jun 28, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PredictWatch
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022