NCT05434429

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 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

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

Study Start

First participant enrolled

June 21, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
6 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 22, 2022

Last Update Submit

June 27, 2022

Conditions

Keywords

AddictionmHealthmobile appCannabisNicotineBehavioral Addiction

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 (11)

  • Binge Eating Disorder Screener-7

    1 week, 5 weeks, 6 months

  • Brief Pornography Screen-PL

    1 week, 5 weeks, 6 months

  • The Cannabis Use Disorder Identification Test - Revised

    1 week, 5 weeks, 6 months

  • The Fagerstrom Test for Nicotine Dependence

    1 week, 5 weeks, 6 months

  • Drug Use Disorders Identification Test

    1 week, 5 weeks, 6 months

  • +6 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: mobile application

Control

NO INTERVENTION

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

Interventions

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.

Intervention

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

MeSH Terms

Conditions

Behavior, AddictiveTobacco Use DisorderMarijuana Abuse

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Alicja A Binkowska, PhD

CONTACT

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 22, 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

Locations