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

Primary Purpose

Addiction, Addiction, Alcohol, Addiction, Substance

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
mobile app
Sponsored by
PredictWatch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring stimulants, alcohol, mobile app, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • PredictWatchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

No Interventions

Short-term interventions

Short-term and long-term interventions

Long-term intervention: Meditations

Long-term intervention: Mindfulness

Long-term intervention: My beliefs

Long-term intervention: Success Diary

Long-term intervention: Gratitude Journal

Long-term intervention: Planner

Long-term intervention: Journey to Sobriety

Long-term intervention: Mood Journal

Long-term intervention: Dream Diary

Long-term intervention: Thinking traps

Arm Description

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Lapses rate according to EMA self-report
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.
Craving level according to EMA self-report
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

Score of Alcohol Use Disorders Identification Test (AUDIT)
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.
Score of Severity of Dependence Scale (SDS)
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).
Score of Satisfaction With Life Scale (SWLS)
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.

Full Information

First Posted
June 21, 2022
Last Updated
June 27, 2022
Sponsor
PredictWatch
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1. Study Identification

Unique Protocol Identification Number
NCT05434416
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PredictWatch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Addiction, Alcohol, Addiction, Substance
Keywords
stimulants, alcohol, mobile app, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Interventions
Arm Type
No Intervention
Arm Description
Given access to all interventions at the end of the 5 weeks of the trial.
Arm Title
Short-term interventions
Arm Type
Experimental
Arm Description
Participants have access only to short-term interventions. Given access to all interventions at the end of the 5 weeks of the trial.
Arm Title
Short-term and long-term interventions
Arm Type
Experimental
Arm Description
Short-term and long-term interventions Participants have access to short-term and all long-term interventions.
Arm Title
Long-term intervention: Meditations
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Mindfulness
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: My beliefs
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Success Diary
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Gratitude Journal
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Planner
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Journey to Sobriety
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Mood Journal
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Dream Diary
Arm Type
Experimental
Arm 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.
Arm Title
Long-term intervention: Thinking traps
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
mobile app
Intervention Description
mobile app self-guided psychological interventions
Primary Outcome Measure Information:
Title
Lapses rate according to EMA self-report
Description
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.
Time Frame
5 weeks
Title
Craving level according to EMA self-report
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Score of Alcohol Use Disorders Identification Test (AUDIT)
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
Score of Severity of Dependence Scale (SDS)
Description
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).
Time Frame
1 week, 5 weeks, 6 months
Title
Score of Satisfaction With Life Scale (SWLS)
Description
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.
Time Frame
1 week, 5 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: are at least 18 years of age speak Polish fluently use either an Android or iOS smartphone Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicja Binkowska, PhD
Email
alicja.binkowska@predictwatch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Skorko
Phone
048792230523
Email
maciek.skorko@predictwatch.com
Facility Information:
Facility Name
PredictWatch
City
Białystok
ZIP/Postal Code
15-668
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicja A Binkowska, PhD
Email
alicja.binkowska@predictwatch.com
First Name & Middle Initial & Last Name & Degree
Maciej Skorko
Phone
+48792230523
Email
maciek.skorko@predictwatch.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://badanienalogow.pl/
Description
Related Info

Learn more about this trial

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

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