AddictionNCT05434429
Mobile Health for Problematic Behaviors and Substance Use
A study testing mobile application in people with Addiction and Behavioral Addiction, run by PredictWatch at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction, Behavioral Addiction, Nicotine Addiction
- What is being tested?
- mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 21 Jun 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are at least 18 years of age
- speak Polish fluently
- use either an Android or iOS smartphone
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Alicja A Binkowska, PhD contact
Poland1 site, 1 recruiting
- Recruiting
PredictWatch
Bialystok, 15-668
Alicja A Binkowska, PhD, alicja.binkowska@predictwatch.com
Maciej Skorko, +48792230523, maciek.skorko@predictwatch.com
About this study
Official title: 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
Read the 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.
- Conditions
- Addiction, Behavioral Addiction, Nicotine Addiction, Nicotine Dependence, Cannabis Dependence
- Being tested
- mobile application
- Keywords
- Addiction, mHealth, mobile app, Cannabis, Nicotine, Behavioral Addiction
- Medical subject headings
- Behavior, Addictive, Tobacco Use Disorder, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants have access to short-term and long-term interventions. Receives: Other: mobile application |
| Control | No intervention | Given access to all interventions at the end of the 5 weeks of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 week, 5 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start21 Jun 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PredictWatch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434429
- Sponsor's protocol ID
- 2022/002A
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Smartphone App to Reduce Craving and Lapse Risk in Problematic Behaviors and Substance Use
- ClinicalTrials.gov ID
- NCT05434429
- Acronym / sponsor ID
- 2022/002A
- Conditions
- Addiction, Behavioral Addiction, Nicotine Addiction, Nicotine Dependence, Cannabis Dependence
- Keywords
- Addiction, mHealth, mobile app, Cannabis, Nicotine, Behavioral Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PredictWatchIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: mobile applicationParticipants have access to short-term and long-term interventions. |
| Control | No intervention | –Given access to all interventions at the end of the 5 weeks of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are at least 18 years of age
- speak Polish fluently
- use either an Android or iOS smartphone
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile applicationParticipants 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. | Other | Intervention |
Primary outcome
Lapses rate according to EMA self-report
Time frame: 5 weeks
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
Time frame: 5 weeks
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.
11 secondary outcomes
Binge Eating Disorder Screener-7
Time frame: 1 week, 5 weeks, 6 months
Brief Pornography Screen-PL
Time frame: 1 week, 5 weeks, 6 months
The Cannabis Use Disorder Identification Test - Revised
Time frame: 1 week, 5 weeks, 6 months
The Fagerstrom Test for Nicotine Dependence
Time frame: 1 week, 5 weeks, 6 months
Drug Use Disorders Identification Test
Time frame: 1 week, 5 weeks, 6 months
Severity of Dependence Scale
Time frame: 1 week, 5 weeks, 6 months
Compulsive Sexual Behavior Disorder
Time frame: 1 week, 5 weeks, 6 months
Satisfaction with Life Scale
Time frame: 1 week, 5 weeks, 6 months
The Hospital Anxiety Depression Scale
Time frame: 1 week, 5 weeks, 6 months
The South Oaks Gambling Screen
Time frame: 1 week, 5 weeks, 6 months
Internet Gaming Disorder Scale-Short-Form
Time frame: 1 week, 5 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicja A Binkowska, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application in people with Addiction and Behavioral Addiction, run by PredictWatch at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicja A Binkowska, PhD (alicja.binkowska@predictwatch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lapses rate according to EMA self-report (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.