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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Substance Use Disorders
- Sponsor
- PredictWatch
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- number of lapses
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
- Not provided
Outcomes
Primary Outcomes
number of lapses
Time Frame: 3 months
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.
addiction craving
Time Frame: 3 months
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.
Secondary Outcomes
- 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)
- Satisfaction with Life Scale (SWLS) score(baseline, one month, two months, three months)
- Coping Orientation to Problems Experienced (mini-COPE) score(baseline, one month, two months, three months)
- Impulsive Behavior Scale (SUPPS) score(baseline, one month, two months, three months)
- Brief Sensation Seeking Scale (BSSS) 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)
- Difficulties in Emotion Regulation Scale (DERS) score(baseline, one month, two months, three months)