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

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

Study Overview

• Status: Recruiting
• Conditions: Addiction; Cannabis Dependence; Nicotine Dependence; Nicotine Addiction; Behavioral Addiction
• Intervention / Treatment: Other: mobile application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicja A Binkowska, PhD; Email: alicja.binkowska@predictwatch.com
• Study Contact Backup: Name: Maciej Skorko; Phone Number: 048792230523; Email: maciek.skorko@predictwatch.com

Study Locations

• Poland
  • Białystok, Poland, 15-668
    • Recruiting
    • PredictWatch
    • Contact: Alicja A Binkowska, PhD; Email: alicja.binkowska@predictwatch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Participants have access to short-term and long-term interventions.	Other: mobile application; 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.
NO_INTERVENTION: Control; Given access to all interventions at the end of the 5 weeks of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Eating Disorder Screener-7	The BEDS-7 screener consists of 7 questions to detect the possibility of the patient having Binge Eating Disorder (BED) (Herman et al., 2016). First, a filter question is asked if the participant experienced at least one episode of excessive overeating during the last 3 months; if answered yes, the next question if about feeling distress from episodes of excessive eating (with possible answers: 'Yes', 'No'), followed by five questions using a Likert-like rating scale ('Never or Rarely', 'Sometimes', 'Often', 'Always'). An answer of 'Yes' to both first two questions with a response of 'Often', 'Always', or 'Sometimes' to questions 3 - 6, and an answer of 'Never or Rarely' or 'Sometimes' to question 7 will yield a result of showing symptoms of BED.	1 week, 5 weeks, 6 months
Brief Pornography Screen-PL	Pornography use will be measure with Brief Pornography Screener (BPS) (Kraus et al., 2019), a 5-item, one-dimensional scale. All questions regards to pornography use in last six month and are scored on 0 ('never') to 2 ('very often'). Minimum score is 0 and maximum is 10. Total score 4 and over indicates problematic pornography use.	1 week, 5 weeks, 6 months
The Cannabis Use Disorder Identification Test - Revised	Cannabis Use Disorder will be accessed with The Cannabis Use Disorders Identification Test-Revised (CUDIT-R) (Adamson et al., 2010), an eight items one-dimensional scale. Questions from 1 to 7 are scored on a 0 ('never) to 4 ('daily or almost daily') scale, and a question 8 is scored as 0 ('never'), 2 ('Yes, but not in the past 6 months') or 4 ('Yes, during the past 6 months'). A score between 8 and 11 indicates hazardous cannabis use, and scores above 12 points indicate possible cannabis use disorder.	1 week, 5 weeks, 6 months
The Fagerstrom Test for Nicotine Dependence	Nicotine dependence was assessed by The Fagerstrom Test for Nicotine Dependence (FTND) (Heatherton et al., 1991). The questionnaire is composed of 6 questions, with varying choices in each question. Each option is accompanied by a number indicating its score for the questionnaire scoring system. The total score is categorized as follows: 0-2 indicates a very low dependence, 3-4 indicates a low dependence, 5-7 indicates a moderate-to-high dependence, lastly, 8+ indicates a very high dependence. In addition, a filter question inquiring if the participant is a user of nicotine products was asked before the questionnaire.	1 week, 5 weeks, 6 months
Drug Use Disorders Identification Test	The Drug Use Disorders Identification Test (DUDIT) (Berman et al., 2005) will be used to measure self-report problematic drug use. The DUDIT is an 11-item screening instrument, the first nine items are scored on a 5-point scale (0 - 4 ), and the last two are scored on a 3-point scale (0, 2, and 4, respectively). The overall score is a sum of scores on all items, with a maximum of 44. A cut-off of >24 has been used for indexing dependence for both sexes (Berman et al., 2005).	1 week, 5 weeks, 6 months
Severity of Dependence Scale	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, while higher values reflect higher dependence.	1 week, 5 weeks, 6 months
Compulsive Sexual Behavior Disorder	Compulsive Sexual Behavior Disorder will be accessed with a short version of the Compulsive Sexual Behavior Disorder Scale (CSBDS-19) (Bőthe et al., 2020), including 19 items with possible answers from 1 - strongly disagree to 4 - strongly agree. Tool has five scales: control (items 1,6,11), salience (items 2, 7, 12, relapse (items 3, 8, 13), dissatisfaction (4, 9, 14), and negative consequences (items 5,10,15, 16, 17, 18, 19). The minimum score is 19, and the maximum is 76, with a cut-off of 50 points indicating possible compulsive sexual behavior disorder.	1 week, 5 weeks, 6 months
Satisfaction with Life Scale	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
The Hospital Anxiety Depression Scale	Depression and anxiety will be assessed with Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983; Karakuła et al., 2017), a 14 items two-dimensional tool. Each subscale consists of 7 items, scoring from 0 to 3. For each subscale, scores between 8 and 10 indicate mild depression/anxiety, and scores between 11 and 21 indicate depression/anxiety disorder.	1 week, 5 weeks, 6 months
The South Oaks Gambling Screen	Gambling disorder will be masured with South Oaks Gambling Screen (SOGS) (Lessieur, et al., 1987) with 16 items of the one-dimensional tool. The participant is asked to indicate the type of gambling he/she practices at least once in his/her life. The first three questions are qualitative: participants indicated how much money they put at risk at maximum in their life, who from their surroundings tend to gamble, and how they come back the next day to get back. The rest of the items are answered yes/no, and each 'yes' answer is rated as 1 point. The score is calculated as a sum (without questions 1,2,3,12, and 16) with 0 meaning no problem with gambling, 1-4 indicating minor issues with gambling, and scores higher than 4 indicating the risk of pathological gambling.	1 week, 5 weeks, 6 months
Internet Gaming Disorder Scale-Short-Form	Gaming disorder was assessed using Internet Gaming Disorder Scale-Short-Form (IGDS9-SF), a 9- items one dimensional tool reflecting nine criteria for Internet Gaming Disorder in DSM-5 (Pontes et al., 2015), Polish version from Schivinski i in. (2018). Items are rated on 5-point scale (1='never', 2= 'rarely', 3='sometimes', 4 = 'often', 5= 'very often') and results can range from a minimum of 9 to a maximum of 45 points, with higher scores indicating higher degree of IGD and a cut-off of 32 (Qin et al., 2020).	1 week, 5 weeks, 6 months

Collaborators and Investigators

• Sponsor: PredictWatch

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; Addiction; Cannabis; Nicotine; Behavioral Addiction; mobile app
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Tobacco Use Disorder; Marijuana Abuse; Behavior, Addictive
• Other Study ID Numbers: 2022/002A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No