Mobile Health for Problematic Behaviors and Substance Use
Evaluating the Effectiveness of a Smartphone App to Reduce Craving and Lapse Risk in Problematic Behaviors and Substance Use
1 other identifier
interventional
600
1 country
1
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 problematic behaviors (compulsive sex, pornography, overeating, gaming, gambling) and substance use (cannabis, nicotine). Participants are randomly assigned to either the intervention group or the control. Participants in the intervention group have access to short-term and long-term interventions, whereas those in the control group only have access to the weekly ecological momentary assessment reports. Participants in the intervention group are able to access the intervention materials 5 days after enrollment and receive weekly ecological momentary assessment reports. Those in the control group will be granted access to all intervention materials after five weeks following study enrollment. A questionnaire battery assessments 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2022
CompletedFirst Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJuly 1, 2022
June 1, 2022
8 months
June 22, 2022
June 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (11)
Binge Eating Disorder Screener-7
1 week, 5 weeks, 6 months
Brief Pornography Screen-PL
1 week, 5 weeks, 6 months
The Cannabis Use Disorder Identification Test - Revised
1 week, 5 weeks, 6 months
The Fagerstrom Test for Nicotine Dependence
1 week, 5 weeks, 6 months
Drug Use Disorders Identification Test
1 week, 5 weeks, 6 months
- +6 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALParticipants have access to short-term and long-term interventions.
Control
NO INTERVENTIONGiven access to all interventions at the end of the 5 weeks of the trial.
Interventions
Participants in the intervention group are able to access the intervention materials 5 days after enrollment. 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.
Eligibility Criteria
You may qualify if:
- are at least 18 years of age
- speak Polish fluently
- use either an Android or iOS smartphone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PredictWatchlead
Study Sites (1)
PredictWatch
Bialystok, 15-668, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 28, 2022
Study Start
June 21, 2022
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
July 1, 2022
Record last verified: 2022-06