Clinical trial NCT05434429: Mobile Health for Problematic Behaviors and Substance Use
Official title: Evaluating the Effectiveness of a Smartphone App to Reduce Craving and Lapse Risk in Problematic Behaviors and Substance Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Behavioral Addiction
Nicotine Addiction
Nicotine Dependence
Cannabis Dependence
Keywords: Addiction
mHealth
mobile app
Cannabis
Nicotine
Behavioral Addiction
Lead sponsor: PredictWatch
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 problematic behaviors and substance use.

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, study participants are randomly assigned to either the intervention group or the control.

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.

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 will be able to access the intervention materials 5 days after enrollment and will 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Lapses rate according to EMA self-report
timeFrame: 5 weeks
measure: Craving level according to EMA self-report
timeFrame: 5 weeks
Secondary outcomes:
measure: Binge Eating Disorder Screener-7
timeFrame: 1 week, 5 weeks, 6 months
measure: Brief Pornography Screen-PL
timeFrame: 1 week, 5 weeks, 6 months
measure: The Cannabis Use Disorder Identification Test - Revised
timeFrame: 1 week, 5 weeks, 6 months
measure: The Fagerstrom Test for Nicotine Dependence
timeFrame: 1 week, 5 weeks, 6 months
measure: Drug Use Disorders Identification Test
timeFrame: 1 week, 5 weeks, 6 months
measure: Severity of Dependence Scale
timeFrame: 1 week, 5 weeks, 6 months
measure: Compulsive Sexual Behavior Disorder
timeFrame: 1 week, 5 weeks, 6 months
measure: Satisfaction with Life Scale
timeFrame: 1 week, 5 weeks, 6 months
measure: The Hospital Anxiety Depression Scale
timeFrame: 1 week, 5 weeks, 6 months
measure: The South Oaks Gambling Screen
timeFrame: 1 week, 5 weeks, 6 months
measure: Internet Gaming Disorder Scale-Short-Form
timeFrame: 1 week, 5 weeks, 6 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: PredictWatch
Study officials:
References: