Mobile Health for Problematic Behaviors and Substance Use
Primary Purpose
Addiction, Behavioral Addiction, Nicotine Addiction
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
mobile application
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Addiction, mHealth, mobile app, Cannabis, Nicotine, Behavioral Addiction
Eligibility Criteria
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 Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants have access to short-term and long-term interventions.
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
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05434429
Brief Title
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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Behavioral Addiction, Nicotine Addiction, Nicotine Dependence, Cannabis Dependence
Keywords
Addiction, mHealth, mobile app, Cannabis, Nicotine, Behavioral Addiction
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
Intervention
Arm Type
Experimental
Arm Description
Participants have access to short-term and long-term interventions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Given access to all interventions at the end of the 5 weeks of the trial.
Intervention Type
Other
Intervention Name(s)
mobile application
Intervention Description
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.
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
Binge Eating Disorder Screener-7
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
Brief Pornography Screen-PL
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
The Cannabis Use Disorder Identification Test - Revised
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
The Fagerstrom Test for Nicotine Dependence
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
Drug Use Disorders Identification Test
Description
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).
Time Frame
1 week, 5 weeks, 6 months
Title
Severity of Dependence Scale
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, while higher values reflect higher dependence.
Time Frame
1 week, 5 weeks, 6 months
Title
Compulsive Sexual Behavior Disorder
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
Satisfaction with Life Scale
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
Title
The Hospital Anxiety Depression Scale
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
The South Oaks Gambling Screen
Description
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.
Time Frame
1 week, 5 weeks, 6 months
Title
Internet Gaming Disorder Scale-Short-Form
Description
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).
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 A 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
Learn more about this trial
Mobile Health for Problematic Behaviors and Substance Use
We'll reach out to this number within 24 hrs