A Gamified Smartphone-Based Intervention for Depression: Randomized Controlled Pilot Trial.
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ABSTRACT: Background
Available smartphone-based interventions for depression predominantly use evidence-based strategies from cognitive-behavioral therapy (CBT), but patient engagement and reported effect sizes are small. Recently, studies have demonstrated that smartphone-based interventions combining CBT with gamified approach-avoidance bias modification training (AAMT) can foster patient engagement and reduce symptoms of several mental health problems.Objective
Based on these findings, we developed a gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), and hypothesized the program would both engage patients and produce preliminary evidence for the reduction of depressive symptoms.Methods
To test this hypothesis, we evaluated MT-Phoenix in a randomized controlled pilot trial including 77 individuals with elevated depression scores (Patient Health Questionnaire-9 scores ≥5). Participants were either instructed to train for 14 days with MT-Phoenix or assigned to a waitlist control condition. Engagement with the intervention was measured by assessing usage data. The primary outcome was reduction in depressive symptom severity at postassessment.Results
Data from this pilot trial shows that participants in the intervention group used the smartphone-based intervention for 46% of all days (6.4/14) and reported a significantly greater reduction of depressive symptoms than did participants in the control condition (F1,74=19.34; P=.001), with a large effect size (d=1.02). Effects were sustained at a 3-month follow-up.Conclusions
A gamified smartphone-based intervention combining CBT with AAMT may foster patient engagement and effectively target depressive symptoms. Future studies should evaluate the effectiveness of this intervention in a phase 3 trial using clinical samples. Moreover, the intervention should be compared to active control conditions.Trial registration
German Clinical Trial Registry DRKS00012769; https://tinyurl.com/47mw8du7.
SUBMITTER: Lukas CA
PROVIDER: S-EPMC8335612 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionInterventions aimed at addressing subthreshold depression (StD) are important to prevent the onset of major depressive disorder. Our video playback application (SPSRS) is designed to reduce depressive symptoms by presenting positive words in videos, shedding new light on the treatment of StD. However, no randomized controlled trial (RCT) has utilized this video playback application for the treatment of individuals with StD. Therefore, a pilot RCT was designed to determine the feasibility of a full-scale trial. We herein present a study protocol for investigating the utility of a video playback application intervention for individuals with StD.MethodsThis 5-week, single-blind, 2-arm, parallel-group, pilot RCT will determine the effectiveness of the video playback application by comparing individuals who had and had not been exposed to the same. A total of 32 individuals with StD will be randomly assigned to the experimental or control group at a 1:1 ratio. The experimental group will receive a 10-minute intervention containing the video playback application per day, whereas the control group will receive no intervention. The primary outcome will include changes in the Center for Epidemiologic Studies Depression Scale score after the 5-week intervention, while secondary outcomes will include changes in the Kessler Screening Scale for psychological distress and the generalized anxiety disorder 7-item scale score after the 5-week intervention. Statistical analysis using linear mixed models with the restricted maximum likelihood estimation method will then be performed.DiscussionThis pilot RCT will have been the first to explore the utility of SPSRS application interventions that display positive words in videos for individuals with StD. The results of this pilot trial are expected to help in the design and implementation of a full-scale RCT that investigates the effects of SPSRS applications among individuals with StD.Trial registrationClinicalTrials.gov Identifier: NCT04136041.
| S-EPMC7004731 | biostudies-literature
Project description:There is a pressing need to ensure that youth in high HIV prevalence settings are prepared for a safer sexual debut. Smartphone ownership is increasing dramatically in low-income and middle-income countries. Smartphone games that are appropriately grounded in behavioral theory and evidence-based practice have the potential to become valuable tools in youth HIV prevention efforts in Sub-Saharan Africa.To pilot-test a theory-based, empirically grounded smartphone game for young Kenyans designed to increase age and condom use at first sex, aiming to establish directionality of effects on behavior change.Tumaini ("hope for the future" in Swahili) is an interactive, narrative-based game grounded in social cognitive theory. A randomized controlled pilot study was conducted in Kisumu, Western Kenya, from April to June 2017 with 60 participants aged 11-14 (mean 12.7) years. Intervention arm participants (n=30) were provided with an Android smartphone with Tumaini installed on it and were instructed to play the game for at least 1 hour a day for 16 days; control arm participants (n=30) received no intervention. All participants completed a survey on behavioral mediators, delivered via an audio computer-assisted self-interview system at baseline (T1), post intervention (T2), and at 6 weeks postintervention (T3). The postintervention survey for intervention arm participants included questions eliciting feedback on the game. Intervention arm participants and their parents participated in 8 postintervention focus group discussions. Game log files were analyzed to calculate the length of exposure to the game. Behavioral survey data were analyzed using two-sample t tests to compare mean change from T1 to T2 and to T3 for intervention versus control arm participants. Descriptive statistics on game feedback questions were computed. Focus group transcripts were uploaded to MAXQDA software, where they were labeled with deductive and inductive codes. Data were analyzed thematically and compared across demographics.Intervention arm participants played Tumaini for a mean of approximately 27 hours. The intervention arm showed significant gains in sexual health-related knowledge and self-efficacy (both P<.001), behavioral intention for risk-avoidance strategies and sexual risk communication (P=.006), and overall survey scores (P<.001) compared with the control arm at T3. The postintervention survey revealed high subjective measures of the game's value, relevance, and appeal. Focus groups identified a wide range of knowledge and skills the participants had gained, including setting goals and planning how to achieve them, which was perceived as a key motivator for avoiding or reducing risk.The study supports the need for further research to assess the efficacy of the game-based intervention. If proven efficacious, smartphone games have the potential to dramatically increase the reach of culturally adapted behavioral interventions while ensuring fidelity to intervention design.ClinicalTrials.gov NCT03054051; http://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/70U2gCNtW).
| S-EPMC6094086 | biostudies-literature
Project description:BackgroundThe majority of adolescents own smartphones, although only 8% of them use health apps. Attrition rates from adolescent mobile health (mHealth) interventions for treating mental health problems such as anxiety and depression are an issue with a high degree of variation. Attrition in mHealth interventions targeting adolescent populations is frequently presented in a two-point fashion, from initiation of the intervention to the end of treatment, lacking more time-specific information on usage and times of attrition. Self-efficacy could provide an avenue to lower attrition rates, although a better understanding of the relationship between mental health factors and time-specific attrition rates is needed.ObjectiveThe aims of this study were to obtain time-specific attrition rates among adolescents in an mHealth intervention, and to describe the intervention's usage and feasibility in relation to adolescent self-efficacy levels, and emotional and physical health.MethodsA single-center randomized controlled public school pilot trial was undertaken with 41 adolescents. Outcome measures were assessed at baseline and after 6 weeks, while in-app activity and attrition rates were continually assessed throughout the intervention period. The primary outcome was attrition based on time and type of in-app health behavior usage, and feasibility of the mHealth app. Secondary outcome measures were self-efficacy levels, depressive and anxiety symptoms, as well as standardized BMI and sleep. Analyses of group mean variances with adjusted α levels through Bonferroni corrections were used to assess main outcome effects.ResultsThe attrition from initiation of the intervention to 6-week follow up was 35%. Attrition started in the third week of the intervention and was related to daily time of app usage (Rt=0.43, P<.001). The number of average weekly in-app health exercises completed decreased significantly from the first week of the intervention (mean 55.25, SD 10.96) to the next week (mean 13.63, SD 2.94). However, usage increased by 22% between week 2 and the last week of the intervention (mean 16.69, SD 8.37). Usability measures revealed satisfactory scores (mean 78.09, SD 9.82) without gender differences (P=.85). Self-reported daily physical activity increased by 19.61% in the intervention group but dropped by 26.21% among controls. Self-efficacy levels increased by 8.23% in the invention arm compared to a 3.03% decrease in the control group.ConclusionsThis pilot study demonstrated the feasibility and usability of an mHealth intervention among adolescent participants. Indications were toward beneficial effects on physical and mental health that warrant further research. Focus on time-specific attrition measures alongside daily times of usage and ways to increase participants' self-efficacy levels appear to be a promising avenue for research on mHealth interventions for adolescent populations with the aim to ultimately lower attrition rates.
| S-EPMC7929738 | biostudies-literature
Project description:BackgroundRepetitive negative thinking (RNT) is a key transdiagnostic mechanism underpinning depression and anxiety. Using "just-in-time adaptive interventions" via smartphones may disrupt RNT in real time, providing targeted and personalized intervention.ObjectiveThis pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical outcomes and mechanisms of Mello-a fully automated, personalized, transdiagnostic, and mechanistic smartphone intervention targeting RNT in young people with depression and anxiety.MethodsParticipants with heightened depression, anxiety, and RNT were recruited via social media and randomized to receive Mello or a nonactive control over a 6-week intervention period. Assessments were completed via Zoom sessions at baseline and at 3 and 6 weeks after baseline.ResultsThe findings supported feasibility and acceptability, with high rates of recruitment (N=55), uptake (55/64, 86% of eligible participants), and retention (52/55, 95% at 6 weeks). Engagement was high, with 90% (26/29) and 59% (17/29) of the participants in the Mello condition still using the app during the third and sixth weeks, respectively. Greater reductions in depression (Cohen d=0.50), anxiety (Cohen d=0.61), and RNT (Cohen d=0.87) were observed for Mello users versus controls. Mediation analyses suggested that changes in depression and anxiety were accounted for by changes in RNT.ConclusionsThe results indicate that mechanistic, targeted, and real-time technology-based solutions may provide scalable and effective interventions that advance the treatment of youth mental ill health.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621001701819; http://tinyurl.com/4d3jfj9f.
| S-EPMC10753417 | biostudies-literature
Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).
| S-EPMC6238853 | biostudies-other
Project description:ObjectivesThis study aims to: (1) identify the information required by family caregivers of people with dementia to be targeted within our dementia family caregiver intervention and (2) test the feasibility of the intervention and methodology to underpin a fully powered randomized controlled trial.MethodsThe study setting will be the Department of Geriatrics at Gia Dinh People's Hospital in Ho Chi Minh City. Inclusion criteria will be the family caregivers of people with dementia living in the community, who attend the Department and use smartphones. In phase 1, we will identify the intervention content with family caregivers of people with dementia through 20 in-depth interviews to determine what information and skills they need. In phase 2, a pilot randomized control trial design will be conducted, with 60 family caregivers of people with dementia being assigned to the intervention or control group by the block randomization method with a ratio of 1:1. The intervention will include weekly, online, psycho-educational, group sessions hosted on the Zalo app. The participants will complete questionnaires at baseline, immediately postintervention, and 3-month postintervention. The feasibility of the intervention and methodology will be assessed, including the rates of recruitment, retention, completion of assessments, and acceptability of the intervention.ResultsThe required information and skills in phase 1 may include dealing with worrying behavior changes in people with dementia, emotional support, and seeking support sources. The rates of recruitment, retention, completion of assessments, and acceptability of the intervention will be obtained in phase 2. The scores of symptoms of stress, depression, and anxiety in the intervention group may be lower than those in the control group at postintervention and 3-month postintervention.ConclusionThe study will provide a foundation for a fully powered clinical trial for the smartphone app-based intervention to reduce stress, depression, and anxiety among family caregivers of people with dementia in Vietnam.
| S-EPMC10014987 | biostudies-literature
Project description:BackgroundDespite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited.ObjectiveThe objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design.MethodsPregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear.ResultsA total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001).ConclusionsSmartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training.Trial registrationChinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474.
| S-EPMC7875700 | biostudies-literature
Project description:BackgroundValidation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large effect sizes (ES) for preschool psychotherapies for several Axis I disorders suggest that earlier intervention in depression may also be promising. Therefore, a novel form of treatment for preschool depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED) was developed and tested.MethodsA preliminary randomized controlled trial (RCT) was conducted comparing PCIT-ED to psycho-education in depressed 3- to 7-year-olds and their caregivers. A total of 54 patients met symptom criteria for DSM-IV major depressive disorder and were randomized, 19 patients completed the active treatment (n = 8 dropouts) and 10 completed psycho-education (n = 17 dropouts).ResultsBoth groups showed significant improvement in several domains, with PCIT-ED showing significance in a greater number of domains. An intent-to-treat analysis suggested that PCIT-ED was significantly more effective than psycho-education on executive functioning (p = .011, ES = 0.12) and emotion recognition skills (p = .002, ES = 0.83).ConclusionsThe RCT proved feasible and suggests an individual control condition should be used in future trials to minimize differential dropout. These pilot data, although limited by power, suggest that PCIT-ED may be a promising early intervention for depression. Larger scale randomized controlled trials of PCIT-ED for depressed preschoolers are now warranted.
| S-EPMC3640820 | biostudies-literature
Project description:BackgroundClear health disparities have emerged in the rates of COVID-19 exposure, hospitalization, and death among Black, Hispanic, and American Indian (BHAI) individuals, relative to non-Hispanic White (NHW) individuals. BHAI populations have been disproportionately affected by lower behavioral health access and heightened negative mental health outcomes during the pandemic.ObjectiveThis project directly addresses health disparities in access to behavioral health care during the COVID-19 pandemic among BHAI populations via an adaptation of the established, initially validated, low-cost, mobile app Easing Anxiety Sensitivity for Everyone (EASE) among individuals with symptoms of elevated anxiety or depression or both.MethodsThe EASE trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. Participants (N=800; n=200, 25%, Black; n=200, 25%, Hispanic; n=200, 25%, American Indian; and n=200, 25%, NHW) are randomized to receive either EASE or an active comparison condition for anxiety and depression. Participants compete an online prescreener, an enrollment call to provide informed consent, a baseline survey, a 6-month intervention period, and 3- and 6-month postbaseline assessments. Select participants also complete a 3- and 6-month postbaseline qualitative interview via phone or an online platform (eg, Zoom). Participants complete 2 scheduled daily ecological momentary assessments (EMAs) during the 6-month study period. These twice-daily EMAs guide a just-in-time approach to immediate, personalized behavioral health care.ResultsOutcomes include reductions in anxiety and depressive symptoms and functional impairment at 3 and 6 months postrandomization. We also will examine putative mechanisms (eg, anxiety sensitivity [AS] and COVID-19-specific stress and fear) of the intervention effects. Further, as treatment effects may differ across sociocultural factors, perceived discrimination, social support, and socioeconomic status (SES) will be evaluated as potential moderators of treatment effects on the primary outcomes. Process evaluation using data collected during the study, as well as individual interviews with participants, will complement quantitative data.ConclusionsData from this efficacy trial will determine whether EASE successfully improves symptoms of anxiety and depression and whether these improvements outperform an active comparison control app. If successful, findings from this study have the potential to decrease anxiety and depression symptoms among vulnerable populations determined to be most at risk of exacerbated, long-lasting negative health sequelae. Data from this study may be used to support an implementation and dissemination trial of EASE within real-world behavioral health and social service settings.Trial registrationClinicalTrials.gov NCT05074693; https://clinicaltrials.gov/ct2/show/NCT05074693.International registered report identifier (irrid)DERR1-10.2196/40713.
| S-EPMC9728024 | biostudies-literature
Project description:BackgroundAlthough most adolescents have access to smartphones, few of them use mobile health (mHealth) apps for health improvement, highlighting the apparent lack of interest in mHealth apps among adolescents. Adolescent mHealth interventions have been burdened with high attrition rates. Research on these interventions among adolescents has frequently lacked detailed time-related attrition data alongside analysis of attrition reasons through usage.ObjectiveThe objective was to obtain daily attrition rates among adolescents in an mHealth intervention to gain a deeper understanding of attrition patterns, including the role of motivational support, such as altruistic rewards, through analysis of app usage data.MethodsA randomized controlled trial was conducted with 304 adolescent participants (152 boys and 152 girls) aged 13-15 years. Based on 3 participating schools, participants were randomly assigned to control, treatment as usual (TAU), and intervention groups. Measures were obtained at baseline, continuously throughout the 42-day trial period (research groups), and at the trial end. The mHealth app is called SidekickHealth and is a social health game with the following 3 main categories: nutrition, mental health, and physical health. Primary measures were attrition based on time from launch, and the type, frequency, and time of health behavior exercise usage. Outcome differences were obtained through comparison tests, while regression models and survival analyses were used for attrition measures.ResultsAttrition differed significantly between the intervention and TAU groups (44.4% vs 94.3%; χ21=61.220; P<.001). The mean usage duration was 6.286 days in the TAU group and 24.975 days in the intervention group. In the intervention group, male participants were active significantly longer than female participants (29.155 vs 20.433 days; χ21=6.574; P<.001). Participants in the intervention group completed a larger number of health exercises in all trial weeks, and a significant decrease in usage was observed from the first to second week in the TAU group (t105=9.208; P<.001) but not in the intervention group. There was a significant increase in health exercises in the intervention group from the fifth to sixth week (t105=3.446; P<.001). Such a significant increase in usage was not evident in the TAU group. The research group was significantly related to attrition time (hazard ratio 0.308, 95% CI 0.222-0.420), as well as the numbers of mental health exercises (P<.001) and nutrition exercises (P<.001).ConclusionsDifferences in attrition rates and usage between groups of adolescents were identified. Motivational support is a significant factor for lowering attrition in adolescent mHealth interventions. The results point to sensitivity periods in the completion of diverse health tasks, and emphasis on time-specific attrition, along with the type, frequency, and time of health behavior exercise usage, is likely a fruitful avenue for further research on mHealth interventions for adolescent populations, in which attrition rates remain excessive.Trial registrationClinicalTrials.gov NCT05912439; https://clinicaltrials.gov/study/NCT05912439.
| S-EPMC10337294 | biostudies-literature