AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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

maciek.skorko@predictwatch.com

Poland1 site, 1 recruiting
  • PredictWatch

    Bialystok, 15-668

    Alicja Binkowska, PhD, alicja.binkowska@predictwatch.com

    Maciej Skorko, +48792230523, maciek.skorko@predictwatch.com

    Recruiting

Other trials in Poland

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 groups in NCT05730504
Study groupRoleWhat they receive
Mobile app-based self-guided interventionsExperimentalParticipants 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 interventionsNo interventionParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted15 Feb 2023
  2. Study start5 Mar 2023
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in