NCT05434416

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 users with substance use disorder or problematic substance use (alcohol and stimulants). Participants are randomly assigned to thirteen different groups to compare the effectiveness of particular long-term interventions. A questionnaire battery assessment 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.

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
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

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

June 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 21, 2022

Last Update Submit

June 27, 2022

Conditions

AddictionAddiction, AlcoholAddiction, Substance

Keywords

stimulantsalcoholmobile appmHealth

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    5 weeks

Secondary Outcomes (3)

  • Score of Alcohol Use Disorders Identification Test (AUDIT)

    1 week, 5 weeks, 6 months

  • Score of Severity of Dependence Scale (SDS)

    1 week, 5 weeks, 6 months

  • Score of Satisfaction With Life Scale (SWLS)

    1 week, 5 weeks, 6 months

Study Arms (13)

No Interventions

NO INTERVENTION

Given access to all interventions at the end of the 5 weeks of the trial.

Short-term interventions

EXPERIMENTAL

Participants have access only to short-term interventions. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Short-term and long-term interventions

EXPERIMENTAL

Short-term and long-term interventions Participants have access to short-term and all long-term interventions.

Other: mobile app

Long-term intervention: Meditations

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Meditations. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Mindfulness

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Mindfulness. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: My beliefs

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: My beliefs. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Success Diary

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Success Diary. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Gratitude Journal

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Gratitude Journal. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Planner

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Planner. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Journey to Sobriety

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Journey to Sobriety. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Mood Journal

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Mood Journal. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Dream Diary

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Dream Diary. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Long-term intervention: Thinking traps

EXPERIMENTAL

Participants have access to short-term interventions. Participants have access to one long-term intervention: Thinking traps. Given access to all interventions at the end of the 5 weeks of the trial.

Other: mobile app

Interventions

mobile appOTHER

mobile app self-guided psychological interventions

Long-term intervention: Dream DiaryLong-term intervention: Gratitude JournalLong-term intervention: Journey to SobrietyLong-term intervention: MeditationsLong-term intervention: MindfulnessLong-term intervention: Mood JournalLong-term intervention: My beliefsLong-term intervention: PlannerLong-term intervention: Success DiaryLong-term intervention: Thinking trapsShort-term and long-term interventionsShort-term interventions

Eligibility Criteria

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

You may qualify if:

  • are at least 18 years of age
  • speak Polish fluently
  • use either an Android or iOS smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PredictWatch

Bialystok, 15-668, Poland

RECRUITING

Related Links

MeSH Terms

Conditions

Behavior, AddictiveAlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorAlcohol-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Alicja Binkowska, PhD

CONTACT

alicja.binkowska@predictwatch.com

Maciej Skorko

CONTACT

048792230523maciek.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

June 21, 2022

First Posted

June 28, 2022

Study Start

June 21, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)