Addiction Clinical Trial
Official title:
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
NCT number | NCT05434416 |
Other study ID # | 2022/001A |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 21, 2022 |
Est. completion date | February 2023 |
Verified date | June 2022 |
Source | PredictWatch |
Contact | Alicja Binkowska, PhD |
alicja.binkowska[@]predictwatch.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - are at least 18 years of age - speak Polish fluently - use either an Android or iOS smartphone Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Poland | PredictWatch | Bialystok |
Lead Sponsor | Collaborator |
---|---|
PredictWatch |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 weeks | |
Primary | 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. | 5 weeks | |
Secondary | 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. | 1 week, 5 weeks, 6 months | |
Secondary | 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). | 1 week, 5 weeks, 6 months | |
Secondary | 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. | 1 week, 5 weeks, 6 months |
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