Dataset Information

Evaluating the effectiveness of mobile app-based self-guided psychological intervention to reduce craving and lapse risk in problematic substance use and behaviors: Protocol for a randomized control trial in the general population.

ABSTRACT:

Background

The prevalence of substance and behavioral addiction is estimated between 10 and 15% of the global population and remains a severe public health concern. Moreover, addiction treatment has several barriers, such as a lack of access to professional treatment or stigmatization. Mobile health interventions emerge as a promising solution.

Methods

This two-armed randomized controlled trial (RCT) aims to assess the efficacy of a mobile app-based self-guided psychological intervention delivered via a smartphone app (Nałogometr) in reducing craving and lapse risk in problematic behaviors and substance use compared to a control condition. Participant recruitment and data collection will start in June 2022 and end in September 2022. Due to the nature of the study, i.e., a nationwide study of problematic substance use and behaviors, we will aim to recruit all individuals willing to participate. The four-week intervention condition includes short-term and long-term modules based mainly on mindfulness and cognitive behavioral therapy. Longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment (EMA). The primary outcomes of interest will be the self-reported number of lapses and craving level in daily EMA. Moreover, a questionnaire battery assessment is administered at baseline in the first week following onboarding, after five weeks, and after six months. The secondary outcome measures will include the severity of problematic substance use or behaviors, anxiety and depression, and life satisfaction.

Results

Results will be submitted for publication in peer-reviewed journals.

Clinical trial registration

[https://clinicaltrials.gov/], identifier [NCT054 34,429].

SUBMITTER: Binkowska AA

PROVIDER: S-EPMC10500479 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating the effectiveness of mobile app-based self-guided psychological intervention to reduce craving and lapse risk in problematic substance use and behaviors: Protocol for a randomized control trial in the general population.

Binkowska Alicja Anna AA Obarska Katarzyna K Marcowski Przemysław P Szymczak Karol K Lewczuk Karol K Sollich Katarzyna K Banaszak Maria M Woronowicz Bohdan B Nowicka Małgorzata M Skorko Maciej M Gola Mateusz M

Contemporary clinical trials communications 20230806

<h4>Background</h4>The prevalence of substance and behavioral addiction is estimated between 10 and 15% of the global population and remains a severe public health concern. Moreover, addiction treatment has several barriers, such as a lack of access to professional treatment or stigmatization. Mobile health interventions emerge as a promising solution.<h4>Methods</h4>This two-armed randomized controlled trial (RCT) aims to assess the efficacy of a mobile app-based self-guided psychological inter ...[more]

PMID: 37720591

Similar Datasets

Project description:BackgroundRisk-appropriate prenatal care has been asserted as a way for the cost-effective delivery of prenatal care. A virtual care model for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight monitoring between visits. Previous studies have demonstrated a safe reduction in the frequency of in-person prenatal care visits among low-risk patients but have noted a reduction in patient satisfaction.ObjectiveThe primary objective of this study was to test the effectiveness of a mobile prenatal care app to facilitate a reduced in-person visit schedule for low-risk pregnancies while maintaining patient and provider satisfaction.MethodsThis controlled trial compared a control group receiving usual care with an experimental group receiving usual prenatal care and using a mobile prenatal care app. The experimental group had a planned reduction in the frequency of in-person office visits, whereas the control group had the usual number of visits. The trial was conducted at 2 diverse outpatient obstetric (OB) practices that are part of a single academic center in Washington, DC, United States. Women were eligible for enrollment if they presented to care in the first trimester, were aged between 18 and 40 years, had a confirmed desired pregnancy, were not considered high-risk, and had an iOS or Android smartphone that they used regularly. We measured the effectiveness of a virtual care platform for prenatal care via the following measured outcomes: the number of in-person OB visits during pregnancy and patient satisfaction with prenatal care.ResultsA total of 88 patients were enrolled in the study, 47 in the experimental group and 41 in the control group. For patients in the experimental group, the average number of in-person OB visits during pregnancy was 7.8 and the average number in the control group was 10.2 (P=.01). There was no statistical difference in patient satisfaction (P>.05) or provider satisfaction (P>.05) in either group.ConclusionsThe use of a mobile prenatal care app was associated with reduced in-person visits, and there was no reduction in patient or provider satisfaction.Trial registrationClinicalTrials.gov NCT02914301; https://clinicaltrials.gov/ct2/show/NCT02914301 (Archived by WebCite at http://www.webcitation.org/76S55M517).

Project description:Co-occurrence of drug misuse with other dysregulated behaviors is common. This study was aimed at exploring the associations between the risk of presenting a clinically relevant condition involving non-substance-related addictive or dysregulated behaviors (as measured by the MultiCAGE CAD-4 screening), and cannabis abuse/dependence (CAST/SDS) scores, and the role of gender therein. Participants were recruited using stratified probabilistic sampling at the University of Granada. Mann-Whitney's U tests were used to compare male and female students in SDS and CAST scores. Associations between gender and MultiCAGE scores were estimated using the γ ordinal correlation index, and tested with χ2. For each MultiCAGE dimension, a Poisson-family mixed-effects model was built with either SDS or CAST as the main input variable, while controlling for nicotine and alcohol dependence, and relevant sociodemographic variables. Incidence rate ratios (IRR) were computed for SDS/CAST effects, and the significance threshold was family-wise Bonferroni-corrected. Gender differences were significant for cannabis dependence/abuse and all MultiCAGE scores for non-substance-related conditions, with males showing higher risk scores for excessive gambling, excessive internet use, excessive video gaming, and hypersexuality, and females presenting higher scores in dysregulated eating and compulsive buying. Cannabis dependence and abuse were significantly associated with a higher risk of problematic video gaming. These associations were mostly driven by males. Importantly, although risk of problematic video gaming was specifically associated with cannabis abuse/dependence, there was only a weak non-significant association between problematic video gaming and alcohol use scores. Risk of alcohol use problems, in turn, was strongly associated with all other non-substance-related problems (problematic gambling, excessive Internet use, dysregulated eating, compulsive buying, and hypersexuality). These differential associations can cast light on the etiological similarities and dissimilarities between problematic substance use and putative addictive behaviors not involving drugs.

Project description:BackgroundPreventing and reducing substance use disorders, sexually transmitted infections (STIs)/HIV, and teen pregnancy, and the associated risk behaviors (ie, substance use and sexual risk behaviors) among youth remain public health priorities in the United States. Equally important is improving the uptake of STI/HIV testing among the youth. Mobile health (mHealth) apps may be a solution to ameliorate these public health concerns; however, few mHealth preventive interventions have demonstrated efficacy in reducing substance use or sexual risk behaviors or improving the uptake of STI/HIV testing among the youth, particularly in clinic settings.ObjectiveThis small-scale study aimed to examine the feasibility of conducting a pilot randomized controlled trial (RCT). We evaluated the effects of Storytelling 4 Empowerment (S4E), relative to enhanced usual practice, on the potential mechanisms by which behavior change occurs, namely clinician-youth risk communication, prevention knowledge, and substance use and sexual risk refusal self-efficacy. We also assessed the ability to measure targeted outcomes of past 30-day substance use (ie, alcohol, tobacco, and other drug use), condomless sex, and alcohol or drug use before sex, as well as the uptake of STI/HIV testing.MethodsEmploying community-based participatory research principles, 50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan, randomized sequentially to either S4E or enhanced usual practice, and assessed at baseline, immediately postintervention, and 30 days postintervention. S4E consists of 3 modules, including alcohol and drug use, tobacco, and STI/HIV.ResultsRelative to youth in the enhanced usual practice group, S4E participants demonstrated higher youth-clinician risk communication (mean 3.22, SD 1.67) and increases in prevention knowledge (∆ score mean 0.36, SD 0.51) and self-efficacy (∆ score mean 0.16, SD 0.47). In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84). The results also suggest a reduction in the proportion of youths who reported past 30-day condomless sex (Cohen h=0.18, 95% CI -0.38 to 0.74) and alcohol use before sex (Cohen h=0.44, 95% CI -0.12 to 1.00). Finally, the findings also demonstrated an increase in the proportion of youths who reported STI/HIV testing over time (Cohen h=0.16, 95% CI -0.39 to 0.72).ConclusionsThe findings suggest the feasibility of a small-scale pilot RCT. S4E demonstrated shifts in the hypothesized direction, reducing substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing among youth in a clinic setting. The findings suggest that a larger RCT may be warranted.Trial registrationClinicalTrails.gov NCT03855410, https://clinicaltrials.gov/ct2/show/NCT03855410.

Project description:BackgroundDuring adolescence, substance use and digital media exposure usually peak and can become major health risks. Prevention activities are mainly implemented in the regular school setting, and youth outside this system are not reached. A mobile app ("Meine Zeit ohne") has been developed specifically for vocational students and encourages participants to voluntarily reduce or abstain from a self-chosen addictive behavior including the use of a substance, gambling, or a media-related habit such as gaming or social media use for 2 weeks. Results from a randomized study indicate a significant impact on health-promoting behavior change after using the app. This exploratory study focuses on the intervention arm of this study, focusing on acceptance and differential effectiveness.ObjectiveThe aims of this study were (1) to examine the characteristics of participants who used the app, (2) to explore the effectiveness of the mobile intervention depending on how the app was used and depending on participants' characteristics, and (3) to study how variations in app use were related to participants' baseline characteristics.MethodsLog data from study participants in the intervention group were analyzed including the frequency of app use (in days), selection of a specific challenge, and personal relevance (ie, the user was above a predefined risk score for a certain addictive behavior) of challenge selection ("congruent use": eg, a smoker selected a challenge related to reducing or quitting smoking). Dichotomous outcomes (change vs no change) referred to past-month substance use, gambling, and media-related behaviors. The relationship between these variables was analyzed using binary, multilevel, mixed-effects logistic regression models.ResultsThe intervention group consisted of 2367 vocational students, and 1458 (61.6%; mean age 19.0, SD 3.5 years; 830/1458, 56.9% male) of them provided full data. Of these 1458 students, 894 (61.3%) started a challenge and could be included in the analysis (mean 18.7, SD 3.5 years; 363/894, 40.6% female). Of these 894 students, 466 (52.1%) were considered frequent app users with more than 4 days of active use over the 2-week period. The challenge area most often chosen in the analyzed sample was related to social media use (332/894, 37.1%). A total of 407 (45.5%) of the 894 students selected a challenge in a behavioral domain of personal relevance. The effects of app use on outcomes were higher when the area of individual challenge choice was equal to the area of behavior change, challenge choice was related to a behavior of personal relevance, and the individual risk of engaging in different addictive behaviors was high.ConclusionsThe domain-specific effectiveness of the program was confirmed with no spillover between behavioral domains. Effectiveness appeared to be dependent on app use and users' characteristics.Trial registrationGerman Clinical Trials Register DRKS00023788; https://tinyurl.com/4pzpjkmj.International registered report identifier (irrid)RR2-10.1186/s13063-022-06231-x.

Project description:BackgroundThe rate of individuals with addiction who are currently treated are low, and this can be explained by barriers such as stigma, desire to cope alone, and difficulty to access treatment. These barriers could be overcome by mobile technologies. EMI (Ecological Momentary Intervention) is a treatment procedure characterized by the delivery of interventions (messages on smartphones) to people in their daily lives. EMI presents opportunities for treatments to be available to people during times and in situations when they are most needed. Craving is a strong predictor of relapse and a key target for addiction treatment. Studies using Ecological Momentary Assessment (EMA) method have revealed that, in daily life, person-specific cues could precipitate craving, that in turn, is associated with a higher probability to report substance use and relapse in the following hours. Assessment and management of these specific situations in daily life could help to decrease addictive use and avoid relapse. The Craving-Manager smartphone app has been designed to diagnose addictive disorders, and assess and manage craving as well as individual predictors of use/relapse. It delivers specific and individualized interventions (counseling messages) composed of evidence-based addiction treatments approaches (cognitive behavioral therapy and mindfulness). The Craving-Manager app can be used for any addiction (substance or behavior). The objective of this protocol is to evaluate the efficacy of the Craving-Manager app in decreasing use (of primary substance(s)/addictive behavior(s)) over 4 weeks, among individuals on a waiting list for outpatient addiction treatment.Methods/designThis multicenter double-blind randomized controlled trial (RCT) will compare two parallel groups: experimental group (full interventional version of the app, 4 weeks, EMA + EMI), versus control group (restricted version of the app, 4 weeks, only EMA). Two hundred and seventy-four participants will be recruited in 6 addiction treatment centers in France.DiscussionThis RCT will provide indication on how the Craving-Manager app will reduce addictive use (e.g., better craving management, better stimulus control) in both substance and behavioral addictions. If its efficacy is confirmed, the app could offer the possibility of an easy to use and personalized intervention accessible to the greatest number of individuals with addiction.Clinical trial registrationClinicalTrials.gov: NCT04732676.

Project description:BACKGROUND:Pregnancy mobile apps are becoming increasingly popular, with parents-to-be seeking information related to their pregnancy and their baby through mobile technology. This increase raises the need for prenatal apps with evidence-based content that is personalized and reliable. Previous studies have looked at whether prenatal apps impact health and behavior outcomes among pregnant and postpartum individuals; however, research has been limited. OBJECTIVE:The primary objective of this study is to assess whether the use of a health system-sponsored mobile app-Circle by Providence-aimed at providing personalized and reliable health information on pregnancy, postpartum recovery, and infant care is associated with improved health outcomes and increased healthy behaviors and knowledge among users. METHODS:This observational study compared app users and app nonusers using a self-reported survey and electronic medical records. The study took place over 18 months and was conducted at Providence St. Joseph Health in Portland, Oregon. The sample included patients who received prenatal care at one of seven Providence clinics and had a live birth at a Providence hospital. Recruitment occurred on a rolling basis and only those who completed the survey were included. Survey respondents were separated into app users and app nonusers, and survey responses and clinical outcomes were compared across groups using univariate and adjusted multivariate logistic regression. RESULTS:A total of 567 participants were enrolled in the study-167 in the app user group and 400 in the nonuser group. We found statistically significant differences between the two groups for certain behavior outcomes: subjects who used the app had 75% greater odds of breastfeeding beyond 6 months postpartum (P=.012), were less likely to miss prenatal appointments (P=.046), and were 50% more likely to exercise 3 or more times a week during pregnancy (P=.04). There were no differences in nutritional measures, including whether they took prenatal vitamins, ate 5 fruits or vegetables a day, or drank caffeine. We found no differences in many of the infant care outcomes; however, there was an increase in awareness of "purple crying." Finally, there were no significant differences in measured clinical health outcomes, including cesarean births, length of hospital stays (in minutes), low birth weight infants, preterm births, small-for-gestational-age births, large-for-gestational-age births, and neonatal intensive care unit stays. CONCLUSIONS:The use of the Circle app, which provides access to personalized and evidence-based health information, was associated with an increase in certain healthy behaviors and health knowledge, although there was no impact on clinical health outcomes. More research is needed to determine the impact of mobile prenatal apps on healthy pregnancies, clinical health outcomes, and infant care.

Project description:BackgroundCollege students endorse high rates of mental health problems. While many colleges offer on-campus services, many students who could benefit from mental health services do not receive care. Indeed, nearly half of students who screen positive for depression, for example, do not receive treatment. Digital mental health programs, such as those delivered via mobile apps, may help expand access to mental health care and resources. This mixed-methods study aims to examine the uptake and effectiveness of an implementation of IntelliCare for College Students, a self-guided app-based mental health platform, on two university campuses.MethodsData on counseling center utilization was collected prior to the implementation of the app (pre-implementation phase) and while the app was available on campus (implementation phase). Data on app usage was collected throughout the implementation phase. A subset of participants (n = 20), along with counseling center staff members (n = 10), completed feedback interviews.ResultsOverall, uptake of the app platform was low. A total of 117 participants downloaded the app and registered their study ID during the implementation phase. Approximately 24% (28/117) of participants used the app only once. The number of days between the first and last day of app use ranged from 0 to 299, with a mean of 35.01 days and a median of 14 days. A relatively small portion of the sample (26.5%; 31/117) downloaded one or more of the IntelliCare interactive apps. In examining counseling center utilization, there were no significant changes in intake appointments, individual therapy sessions, or crisis appointments observed from the pre-implementation phase to the implementation phase of the study. Feedback interviews highlighted the significant level of disruption caused by the COVID-19 pandemic and shift to remote learning, including challenges disseminating information to students and a preference to spend less time with digital devices outside of class time.ConclusionsFindings from this study indicate that there is an ongoing need to identify ways to reach college students and support student mental health and wellness for the remainder of the COVID-19 pandemic and beyond.

Dataset Information

Evaluating the effectiveness of mobile app-based self-guided psychological intervention to reduce craving and lapse risk in problematic substance use and behaviors: Protocol for a randomized control trial in the general population.

Background

Methods

Results

Clinical trial registration

Publications

Evaluating the effectiveness of mobile app-based self-guided psychological intervention to reduce craving and lapse risk in problematic substance use and behaviors: Protocol for a randomized control trial in the general population.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets