Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder

NCT ID: NCT05730504

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-05

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Substance Use Disorders Addiction, Alcohol Addiction, Substance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mobile app-based self-guided interventions

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

Group Type EXPERIMENTAL

Mobile app-based self-guided interventions

Intervention Type OTHER

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

No interventions

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile app-based self-guided interventions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PredictWatch

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PredictWatch

Bialystok, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Alicja Binkowska, PhD

Role: CONTACT

+48792230523

Maciej Skorko

Role: CONTACT

Facility Contacts

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Alicja Binkowska, PhD

Role: primary

Maciej Skorko

Role: backup

+48792230523

References

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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.

Reference Type DERIVED
PMID: 38784165 (View on PubMed)

Other Identifiers

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2023/003A

Identifier Type: -

Identifier Source: org_study_id

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