Substance Use DisordersNCT05730504
Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder
A study testing Mobile app-based self-guided interventions in people with Substance Use Disorders and Addiction, Alcohol, run by PredictWatch at 1 site in Poland.
Trial summary
The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder. In a two-armed, randomized controlled trial the efficacy of self-guided psychological intervention delivered via a mobile app (Nałogometr 2.0) will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Addiction, Alcohol, Addiction, Substance
- What is being tested?
- Mobile app-based self-guided interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 5 Mar 2023to Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of a Substance Use Disorder (SUD)
- addiction to either alcohol, cannabis, or cross-addiction (alcohol + stimulants)
- min. 18 years of age
- fluent polish speakers
- users of Android or IOS smartphones
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Maciej Skorko contact
Poland1 site, 1 recruiting
- Recruiting
PredictWatch
Bialystok, 15-668
Alicja Binkowska, PhD, alicja.binkowska@predictwatch.com
Maciej Skorko, +48792230523, maciek.skorko@predictwatch.com
About this study
Official title: Evaluating the Effectiveness of a Mobile App-based Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder: Protocol for a Randomized Controlled Trial
The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder. In a two-armed, randomized controlled trial the efficacy of self-guided psychological intervention delivered via a mobile app (Nałogometr 2.0) will be assessed. During the course of three months, participants will have access to intervention modules, based mainly on mindfulness and cognitive behavioral therapy (CBT). With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered monthly - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.
Read the detailed description
The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder.
Participants will be recruited from clinical patients receiving either in-patient or out-patient treatments for Substance Use Disorder (SUD) and enrolled in one of three groups: 1) Patients with alcohol addiction, 2) Patients with cross-addiction (alcohol and stimulants), 3) Patients with cannabis addiction.
Participants will be randomly assigned to either intervention or control condition. The mobile interventions will be delivered via a mobile app Nałogometr 2.0, freely available. Participants in the intervention condition will have free access to all of the app functionalities, while the control group won't gain access to the interventions until after study completion.
Interventions consist of audio-guided, short sessions on gratitude, thoughts management, motivation, relaxation, audio-guided mindfulness sessions concentrated on raising awareness of emotions and body signals or coping with stress, as well as CBT-based written sessions grounded in thought management and journaling techniques.
With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered at baseline, after one month, after two months, and after three months - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.
- Being tested
- Mobile app-based self-guided interventions
- Keywords
- mHealth, substance use disorder, alcohol, cannabis, stimulants
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app-based self-guided interventionsOther
self-guided, app-based mobile psychological interventions based on CBT, meditation, mindfulness, journaling, and audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation
| Study group | Role | What they receive |
|---|---|---|
| Mobile app-based self-guided interventions | Experimental | Participants have access to self-guided, app-based mobile psychological interventions grounded in Cognitive Behavioral Therapy, meditation, mindfulness, journaling, as well as audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation Receives: Other: Mobile app-based self-guided interventions |
| No interventions | No intervention | Participants don't have access to app-based mobile psychological interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of lapses
self-reported number of lapses collected during daily Ecological Momentary Assessment - an item asking if the lapse occurred since the last survey (yes / no). The frequency of lapses will be tracked for changes over time.
Measured: 3 months
addiction craving
self-reported intensity of craving collected during daily Ecological Momentary Assessment - an item asking how strong is the urge to use on a scale from 0 to 6, where 0 means no urge, and 6 - an overwhelming urge. The score will be tracked for changes over time.
Measured: 3 months
Secondary outcomes (10)
Alcohol Use Disorder Identification Test (AUDIT) score
Problematic alcohol use will be measured with an Alcohol Use Disorders Identification Test (AUDIT). AUDIT assesses the amount and frequency of alcohol intake (items 1-3), alcohol dependence (questions 4-6), and problems related to alcohol consumption (items 7-10). Questions 1 to 8 are scored on a 5-point scale ranging from 0 to 4, and questions 9 and 10 are scored as 0, 2, or 4. Total scores range from 0 to 40, and the cut-off point to identify hazardous alcohol intake is 8, a score between 16 and 19 indicates harmful alcohol use, and scores above 20 points indicate possible alcohol use disorder. Participants will answer the questions in terms of standard drinks.
Measured: baseline, one month, two months, three months
Severity of Dependence Scale (SDS) score
The Severity of Dependence Scale (SDS) 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 - a cut-off of =< 3 has been used for indexing alcohol dependence and =< 5 for indexing amphetamine dependence.
Measured: baseline, one month, two months, three months
Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score
Cannabis Use Disorders Identification Test-Revised (CUDIT-R) will be administered in a group of patients with cannabis addiction to assess cannabis consumption, abuse, dependence, and psychological features. The questionnaire consists of 7 items scored on a 0-4 scale, and the last question is scored on a three point scale (0-2-4). Scores of 8 or more indicate hazardous cannabis use, and the cut-off for possible cannabis use disorder is =<12 points.
Measured: baseline, one month, two months, three months
Drug Use Disorders Identification Test (DUDIT) score
Drug Use Disorders Identification Test (DUDIT) is an 11-item screening questionnaire measuring drug intake and severity of substance ause and dependence. Items 1 to 9 are scored on a five-point Likert scale, and items 10 and 11 are scored on a three-point scale (0-2-4). Scores of 25 points or more are probably indicative of heavy dependence on drugs.
Measured: baseline, one month, two months, three months
Hospital Depression and Anxiety Scale (HADS) score
Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with two subscales, each consisting of 7 items. For both subscales, scores between 8-10 indicate mild depression or anxiety, and scores in the range of 11-21 are indicative of depression or anxiety disorder.
Measured: baseline, one month, two months, three months
Difficulties in Emotion Regulation Scale (DERS) score
Emotion regulation will be assessed with Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire, rated on a scale from 1 (almost never) to 5 (almost always). It consists of 6 subscales. Higher scores suggest greater difficulties in emotion regulation.
Measured: baseline, one month, two months, three months
Satisfaction with Life Scale (SWLS) score
Participants' satisfaction with their life will be assessed with The Satisfaction With Life Scale (SWLS), 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: baseline, one month, two months, three months
Coping Orientation to Problems Experienced (mini-COPE) score
Coping Orientation to Problems Experienced (mini-COPE) questionnaire measures coping styles used to deal with difficult situations It consists of 28 items and three subscales corresponding to three coping styles. Higher scores on each of the subscale indicate increased usage of a corresponding coping style.
Measured: baseline, one month, two months, three months
Impulsive Behavior Scale (SUPPS) score
Impulsive Behavior Scale (SUPPS) is a 20-item measure of impulsive traits. It consists of 20 items, with answers ranging from 1 = 'strongly agree' to 4 = 'strongly disagree'.
Measured: baseline, one month, two months, three months
Brief Sensation Seeking Scale (BSSS) score
Brief Sensation Seeking Scale (BSSS) is a short, 8-item scale measuring sensation seeking. Responses are made on a 5-point scale, where higher score indicate stronger agreement. Higher scores indicate more impulsive behavior.
Measured: baseline, one month, two months, three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 Mar 2023
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PredictWatch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730504
- Sponsor's protocol ID
- 2023/003A
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Redel A, Binkowska AA, Obarska K, Marcowski P, Szymczak K, Lewczuk K, Solich K, Banaszak M, Woronowicz B, Nowicka M, Skorko M, Gola M, Bielecki M. Evaluating the effectiveness of a mobile app-based self-guided psychological interventions to reduce relapse in substance use disorder: protocol for a randomized controlled trial. Front Psychiatry. 2024 May 8;15:1335105. doi: 10.3389/fpsyt.2024.1335105. eCollection 2024.
PubMed 38784165
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Mobile App-based Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05730504
- Acronym / sponsor ID
- 2023/003A
- Keywords
- mHealth, substance use disorder, alcohol, cannabis, stimulants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PredictWatchIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Feb 2023 (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 mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder. In a two-armed, randomized controlled trial the efficacy of self-guided psychological intervention delivered via a mobile app (Nałogometr 2.0) will be assessed. During the course of three months, participants will have access to intervention modules, based mainly on mindfulness and cognitive behavioral therapy (CBT). With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered monthly - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.
Detailed description
The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder.
Participants will be recruited from clinical patients receiving either in-patient or out-patient treatments for Substance Use Disorder (SUD) and enrolled in one of three groups: 1) Patients with alcohol addiction, 2) Patients with cross-addiction (alcohol and stimulants), 3) Patients with cannabis addiction.
Participants will be randomly assigned to either intervention or control condition. The mobile interventions will be delivered via a mobile app Nałogometr 2.0, freely available. Participants in the intervention condition will have free access to all of the app functionalities, while the control group won't gain access to the interventions until after study completion.
Interventions consist of audio-guided, short sessions on gratitude, thoughts management, motivation, relaxation, audio-guided mindfulness sessions concentrated on raising awareness of emotions and body signals or coping with stress, as well as CBT-based written sessions grounded in thought management and journaling techniques.
With the use of ecological momentary assessment (EMA), longitudinal data on several variables related to craving and lapse risk will be collected. Additionally, a questionnaire battery assessment - administered at baseline, after one month, after two months, and after three months - will measure severity of substance dependence, levels of anxiety, depression, and life satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app-based self-guided interventions | Experimental | Other: Mobile app-based self-guided interventionsParticipants have access to self-guided, app-based mobile psychological interventions grounded in Cognitive Behavioral Therapy, meditation, mindfulness, journaling, as well as audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation |
| No interventions | No intervention | –Participants don't have access to app-based mobile psychological interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of a Substance Use Disorder (SUD)
- addiction to either alcohol, cannabis, or cross-addiction (alcohol + stimulants)
- min. 18 years of age
- fluent polish speakers
- users of Android or IOS smartphones
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 app-based self-guided interventionsself-guided, app-based mobile psychological interventions based on CBT, meditation, mindfulness, journaling, and audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation | Other | Mobile app-based self-guided interventions |
Primary outcome
number of lapses
Time frame: 3 months
self-reported number of lapses collected during daily Ecological Momentary Assessment - an item asking if the lapse occurred since the last survey (yes / no). The frequency of lapses will be tracked for changes over time.
addiction craving
Time frame: 3 months
self-reported intensity of craving collected during daily Ecological Momentary Assessment - an item asking how strong is the urge to use on a scale from 0 to 6, where 0 means no urge, and 6 - an overwhelming urge. The score will be tracked for changes over time.
10 secondary outcomes
Alcohol Use Disorder Identification Test (AUDIT) score
Time frame: baseline, one month, two months, three months
Severity of Dependence Scale (SDS) score
Time frame: baseline, one month, two months, three months
Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score
Time frame: baseline, one month, two months, three months
Drug Use Disorders Identification Test (DUDIT) score
Time frame: baseline, one month, two months, three months
Hospital Depression and Anxiety Scale (HADS) score
Time frame: baseline, one month, two months, three months
Difficulties in Emotion Regulation Scale (DERS) score
Time frame: baseline, one month, two months, three months
Satisfaction with Life Scale (SWLS) score
Time frame: baseline, one month, two months, three months
Coping Orientation to Problems Experienced (mini-COPE) score
Time frame: baseline, one month, two months, three months
Impulsive Behavior Scale (SUPPS) score
Time frame: baseline, one month, two months, three months
Brief Sensation Seeking Scale (BSSS) score
Time frame: baseline, one month, two months, three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 38784165Redel A, Binkowska AA, Obarska K, Marcowski P, Szymczak K, Lewczuk K, Solich K, Banaszak M, Woronowicz B, Nowicka M, Skorko M, Gola M, Bielecki M. Evaluating the effectiveness of a mobile app-based self-guided psychological interventions to reduce relapse in substance use disorder: protocol for a randomized controlled trial. Front Psychiatry. 2024 May 8;15:1335105. doi: 10.3389/fpsyt.2024.1335105. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Maciej Skorko 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 app-based self-guided interventions in people with Substance Use Disorders and Addiction, Alcohol, 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 5 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 29 Mar 2023. 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 Binkowska, PhD (+48792230523, alicja.binkowska@predictwatch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of lapses (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05730504, which also lists 1 linked publication.
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 29 Mar 2023.