Clinical trial NCT05730504: Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Addiction, Alcohol
Addiction, Substance
Keywords: mHealth
substance use disorder
alcohol
cannabis
stimulants
Lead sponsor: PredictWatch
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: number of lapses
timeFrame: 3 months
measure: addiction craving
timeFrame: 3 months
Secondary outcomes:
measure: Alcohol Use Disorder Identification Test (AUDIT) score
timeFrame: baseline, one month, two months, three months
measure: Severity of Dependence Scale (SDS) score
timeFrame: baseline, one month, two months, three months
measure: Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score
timeFrame: baseline, one month, two months, three months
measure: Drug Use Disorders Identification Test (DUDIT) score
timeFrame: baseline, one month, two months, three months
measure: Hospital Depression and Anxiety Scale (HADS) score
timeFrame: baseline, one month, two months, three months
measure: Difficulties in Emotion Regulation Scale (DERS) score
timeFrame: baseline, one month, two months, three months
measure: Satisfaction with Life Scale (SWLS) score
timeFrame: baseline, one month, two months, three months
measure: Coping Orientation to Problems Experienced (mini-COPE) score
timeFrame: baseline, one month, two months, three months
measure: Impulsive Behavior Scale (SUPPS) score
timeFrame: baseline, one month, two months, three months
measure: Brief Sensation Seeking Scale (BSSS) score
timeFrame: baseline, one month, two months, three months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: PredictWatch
Study officials:
References: