NCT05730504

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

March 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 3, 2023

Last Update Submit

March 28, 2023

Conditions

Substance Use DisordersAddiction, AlcoholAddiction, Substance

Keywords

mHealthsubstance use disorderalcoholcannabisstimulants

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Secondary Outcomes (10)

  • Alcohol Use Disorder Identification Test (AUDIT) score

    baseline, one month, two months, three months

  • Severity of Dependence Scale (SDS) score

    baseline, one month, two months, three months

  • Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score

    baseline, one month, two months, three months

  • Drug Use Disorders Identification Test (DUDIT) score

    baseline, one month, two months, three months

  • Hospital Depression and Anxiety Scale (HADS) score

    baseline, one month, two months, three months

  • +5 more secondary outcomes

Study Arms (2)

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

Other: Mobile app-based self-guided interventions

No interventions

NO INTERVENTION

Participants don't have access to app-based mobile psychological interventions

Interventions

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

Mobile app-based self-guided interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PredictWatch

Bialystok, 15-668, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38784165DERIVED

MeSH Terms

Conditions

Substance-Related DisordersAlcoholismMarijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Central Study Contacts

Alicja Binkowska, PhD

CONTACT

+48792230523alicja.binkowska@predictwatch.com

Maciej Skorko

CONTACT

maciek.skorko@predictwatch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 15, 2023

Study Start

March 5, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)