Guided digital health intervention for depression in Lebanon: randomised trial.
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ABSTRACT: Background
Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic.Objective
To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic.Methods
We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment.Findings
680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97), impaired functioning (SMD: 0.43; 95% CI: 0.21 to 0.65), post-traumatic stress (SMD: 0.53; 95% CI: 0.27 to 0.79), anxiety (SMD: 0.74; 95% CI: 0.49 to 0.99), subjective well-being (SMD: 0.37; 95% CI: 0.12 to 0.62) and self-identified personal problems (SMD: 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up.Conclusions
Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition.Clinical implications
Guided digital mental health interventions should be considered for implementation in LMICs.Trial registration number
ClinicalTrials.gov NCT03720769.
SUBMITTER: Cuijpers P
PROVIDER: S-EPMC9811068 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
Publications
Guided digital health intervention for depression in Lebanon: randomised trial.
Cuijpers Pim P Heim Eva E Ramia Jinane Abi JA Burchert Sebastian S Carswell Kenneth K Cornelisz Ilja I Knaevelsrud Christine C Noun Philip P van Klaveren Chris C Van't Hof Edith E Zoghbi Edwina E van Ommeren Mark M El Chammay Rabih R
Evidence-based mental health 20220516 e1
<h4>Background</h4>Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic.<h4>Objective</h4>To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring ec ...[more]
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Project description:BackgroundMost displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon.Methods and findingsWe conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate.ConclusionsIn this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access.Trial registrationClinicalTrials.gov NCT03720769.
| S-EPMC9223343 | biostudies-literature
Project description:IntroductionDigital interventions are increasingly regarded as a potential solution for the inaccessibility of mental health treatment across low-and-middle-income settings, especially for common mental disorders. Step-by-Step (SbS) is a digital, guided self-help intervention for depression found effective in two Randomized Controlled Trials (RCTs) in Lebanon. For research implementation and further scale-up, this paper reports the results of a qualitative evaluation of SbS among the Lebanese and others and displaced Syrians in Lebanon.MethodsThirty-four Key Informant Interviews (KIIs) were executed with participants of the RCTs, SbS staff members, and external stakeholders. Questions garnered feedback about the feasibility, acceptability, enabling factors, and barriers to adhering to the research, implementation, and the SbS intervention. A thematic analysis was conducted using NVivo, and key themes, topics, and recommendations, on research methods and the intervention itself, were generated and reported.ResultsResults showed a high level of acceptability of SbS among Lebanese and Syrians and identified sub-groups for whom acceptance or use might be lower, such as older adults and people with limited access to the internet or smartphones. Furthermore, interviews identified the main enabling factors and barriers to adherence related to the research design, content, and delivery approach. Barriers related to feasibility included lengthy assessments as part of the RCTs, and mistrust related to delays in study compensations. Other common challenges were forgetting login credentials, poor internet connection, being busy and competing needs. Enabling factors and best practices included motivating participants to use the intervention through the weekly support provided by helpers, setting an oral contract for commitment, and dividing the compensations into several installments as part of the RCTs. Recommendations regarding sustainability were given.DiscussionThe findings show that overall, SbS is feasible, acceptable, and much needed in Lebanon among the Lebanese and Syrians. This assessment identifies reasons for low adherence to the research and the intervention and presents improvement solutions. Recommendations generated in this paper inform the upscale of SbS and the planning, design, and implementation of future digital interventions in research and service provision settings in the mental health field.
| S-EPMC10840138 | biostudies-literature
Project description:OBJECTIVES:To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns. TRIAL DESIGN:Two-arm cluster randomised controlled trial. METHODS:Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ≤35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group). INTERVENTIONS:intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches. OUTCOME MEASURES:primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment. RESULTS:Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed). OUTCOME:K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI -1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups. CONCLUSIONS:the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development. TRIAL REGISTRATION NUMBER:ACTRN12613000041752; Pre-results.
| S-EPMC6398763 | biostudies-literature
Project description:IntroductionOur aim is to investigate whether a shortened digital self-care intervention is non-inferior to, and cost-effective compared with, a comprehensive and therapist-guided cognitive behavioural therapy treatment for atopic dermatitis (AD).Methods and analysisThis is a single-blind, randomised clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. We will recruit 174 adult participants with AD through self-referral. Participants will be randomised 1:1 to the two experimental conditions. Participants randomised to guided care will receive internet-delivered cognitive behavioural therapy for 12 weeks. Participants randomised to digital self-care will have access to this self-guided intervention for 12 weeks. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analysed intention to treat. We define non-inferiority as a three-point difference on the primary outcome measure (Patient-oriented Eczema Measure). Recruitment started in November 2022.Ethics and disseminationThis study is approved by the Swedish ethics authority (reg. no 2021-06704-01) and is preregistered at ClinicalTrials.gov. The study will be reported according to the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results of the study will be published in peer-reviewed scientific journals and disseminated to patient organisations and media.Trial registration numberNCT05517850.
| S-EPMC9980367 | biostudies-literature
Project description:BackgroundDepression in adolescents is a large and growing problem; however, access to effective mental health care continues to be a challenge. Digitally based interventions may serve to bridge this access gap for adolescents in need of care. Digital interventions that deliver components of cognitive behavioral therapy (CBT) have been shown to reduce symptoms of depression, and virtual reality (VR) may be a promising adjunctive component. However, research on these types of treatments in adolescents and young adults is limited.ObjectiveThis study aims to evaluate the feasibility, acceptability, and preliminary efficacy of Spark (v1.0), a 5-week, self-guided, CBT-based digital program using a mobile app and VR experiences to target symptoms of depression in adolescents.MethodsA single-arm, open-label study of the Spark program was conducted with a community sample of 30 adolescents and young adults aged 12 to 21 years with self-reported moderate to severe depression symptoms. Participants completed a weekly depression assessment (Patient Health Questionnaire-8) in the app during the 5-week intervention period as well as web-based baseline, postintervention, and 1-month follow-up self-report assessments. The participants also completed a qualitative postintervention interview. For participants aged <18 years, caregivers completed assessments at baseline and postintervention time points. Feasibility outcomes included recruitment rate (the proportion of participants who enrolled in the study divided by the total number of participants screened for eligibility) and retention rate (the proportion of participants who completed postintervention assessments divided by the total number of participants who received the intervention). Acceptability outcomes included engagement with the program and quantitative and qualitative feedback about the program. Preliminary efficacy was evaluated based on the Patient Health Questionnaire-8.ResultsThe study recruitment (31/66, 47%) and retention (29/30, 97%) rates were high. Participants provided higher ratings for the ease of use of the Spark program (8.76 out of 10) and their enjoyment of both the mobile app (7.00 out of 10) and VR components (7.48 out of 10) of the program, whereas they provided lower ratings for the program's ability to improve mood (4.38 out of 10) or fit into their daily routines (5.69 out of 10). We observed a clinically and statistically significant reduction in depression scores at postintervention (mean difference 5.36; P<.001) and 1-month follow-up (mean difference 6.44; P<.001) time points.ConclusionsThe Spark program was found to be a feasible and acceptable way to deliver a self-guided CBT-focused intervention to adolescents and young adults with symptoms of depression. Preliminary data also indicated that the Spark program reduced the symptoms of depression in adolescents and young adults. Future studies should evaluate the efficacy of this intervention in an adequately powered randomized controlled trial.Trial registrationClinicalTrials.gov NCT04165681; https://classic.clinicaltrials.gov/ct2/show/NCT04165681.
| S-EPMC10701656 | biostudies-literature
Project description:IntroductionUnhealthy lifestyle behaviours continue to be highly prevalent, including alcohol consumption, unhealthy diets, insufficient physical activity and smoking. There is a lack of effective interventions which have a large enough reach into the community to improve public health. Additionally, the common co-occurrence of multiple unhealthy behaviours demands investigation of efforts which address more than single behaviours.Methods and analysisThe effects of six components of a novel digital multiple health behaviour change intervention on alcohol consumption, diet, physical activity and smoking (coprimary outcomes) will be estimated in a factorial randomised trial. The components are designed to facilitate behaviour change, for example, through goal setting or increasing motivation, and are either present or absent depending on allocation (ie, six factors with two levels each). The study population will be those seeking help online, recruited through search engines, social media and lifestyle-related websites. Included will be those who are at least 18 years of age and have at least one unhealthy behaviour. An adaptive design will be used to periodically make decisions to continue or stop recruitment, with simulations suggesting a final sample size between 1500 and 2500 participants. Multilevel regression models will be used to analyse behavioural outcomes collected at 2 months and 4 months postrandomisation.Ethics and disseminationApproved by the Swedish Ethical Review Authority on 2021-08-11 (Dnr 2021-02855). Since participation is likely motivated by gaining access to novel support, the main concern is demotivation and opportunity cost if the intervention is found to only exert small effects. Recruitment began on 19 October 2021, with an anticipated recruitment period of 12 months.Trial registration numberISRCTN16420548.
| S-EPMC9330315 | biostudies-literature
Project description:BackgroundDepression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs.MethodsThis multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond.DiscussionThe SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care.Trial registrationISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.
| S-EPMC10964704 | biostudies-literature
Project description:BackgroundE-mental health is an established mode of delivering treatment for common mental disorders in many high income countries. However, evidence of its effectiveness in lower income countries is lacking. This mixed methods study presents lessons learned and preliminary data on the feasibility of a minimally guided e-mental health intervention in Lebanon. The aim was to pilot test Step-by-Step, a WHO guided e-mental health intervention, and research methods prior to future, controlled testing.MethodsParticipants were recruited using social media and advertisements in primary care clinics. Participants completed baseline and post-intervention questionnaires on depression symptoms (primary outcome, PHQ-8), anxiety symptoms, well-being, disability and self-perceived problem severity, and a client satisfaction questionnaire. In addition, seven completers, four drop-outs, 11 study staff, and four clinic managers were interviewed with responses thematically analyzed. Website analytics were used to understand participant behavior when using the website.ResultsA total of 129 participants signed up via the Step-by-Step website. Seventy-four participants started session 1 after completing pre-test questionnaires and 26 completed both baseline and post-intervention data. Among those who completed post-assessments, depression symptoms improved (PHQ-8 scores (t=5.62, p < 0.001 two-tailed, df = 25). Wilcoxon signed ranks tests showed a significant difference between baseline and post-Step-by-Step scores on all secondary outcome measures. Client satisfaction data was positive. Interview responses suggested that the intervention could be made more appropriate for younger, single people, more motivating, and easier to use. Those who utilized the support element of the intervention were happy with their relationship with the non-specialist support person (e-helper), though some participants would have preferred specialist support. E-helpers would have liked more training on complex cases. Website analytics showed that many users dropped out before intervention start, and that some re-entered screening data having been excluded from the study.ConclusionStep-by-Step skills and techniques, model of service integration, and its non-specialist support element are acceptable. Though the sample was small and non-controlled and drop-out was high, results suggest that it may be effective in reducing depression and anxiety symptoms and increasing well-being. Lessons learned will inform content revision, the development of an app version of Step-by-Step, and the research methodology of upcoming effectiveness studies.
| S-EPMC7034323 | biostudies-literature
Project description:BackgroundAdolescent depression is a significant public health concern; however, access to effective mental health care is limited. Digital therapeutics (DTx) can improve access to evidence-based interventions; however, their efficacy in adolescents is sparsely documented.ObjectiveThis study aims to examine the efficacy of a mobile app DTx versus an active control as an adjunct treatment for adolescent depression symptoms.MethodsAn internet-based open-label randomized control trial was conducted nationwide with a partial crossover design, and 168 adolescents aged 13 to 21 years with symptoms of depression were recruited between November 2020 and September 2021. Participants were randomized (1:1) to the cognitive behavioral therapy-based treatment app (Spark) or to a psychoeducational control app (control), which they would use for a duration of 5 weeks. The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as measured by the Patient Health Questionnaire-8 (PHQ-8) using a linear mixed-effects analysis. The PHQ-8 ranges from 0 to 24, with scores of 5 to 9 indicating mild depression symptoms, scores of 10 to 14 indicating moderate symptoms, scores of 15 to 19 indicating moderately severe symptoms, and scores of 20 to 24 indicating severe symptoms. A minimal clinically important difference (5-point reduction between baseline and postintervention) in the Spark arm and group differences in remission and treatment response rates based on the PHQ-8 at postintervention were also investigated.ResultsA total of 160 participants were randomized, 80 in the Spark arm (mean age 16.89, SD 2.5 y) and 80 in the control arm (mean age 16.79, SD 2.59 y). Data from 121 participants (Spark: n=63; control: n=58) with moderate to severe (PHQ-8≥10) symptoms at baseline were included in the primary analyses following a modified intention-to-treat principle. A linear mixed-effect analysis revealed a nonsignificant difference between the study arms in depression symptom change over the intervention period. The Spark arm met a minimal clinically important difference threshold (mean -5.08, 95% CI -6.72 to -3.42). The remission rate in the Spark arm was significantly higher than that in the control arm (11/63, 17% vs 2/58, 3%; χ21=6.2; P=.01; false discovery rate-adjusted P=.03). The treatment response rates were not significantly different between the study arms (P=.07; false discovery rate-adjusted P=.16). Post hoc analyses including participants with mild to severe (PHQ-8 score ≥5) symptoms at baseline revealed promising evidence that Spark is effective in those with mild to severe symptoms.ConclusionsThere is initial evidence that a self-guided, cognitive behavioral therapy-based DTx intervention may effectively treat mild to severe depression symptoms in adolescents. DTx may improve access to mental health care for adolescents or serve as an important adjunct to the standard of care.Trial registrationClinicalTrials.gov NCT04524598; https://clinicaltrials.gov/study/NCT04524598.
| S-EPMC10882470 | biostudies-literature
Project description:ObjectiveAccess to effective treatments for adolescents with depression needs to improve. Few studies have evaluated behavioural activation (BA) for adolescent depression, and none remotely delivered BA. This study explored the feasibility and acceptability of therapist-guided and self-guided internet-delivered BA (I-BA) in preparation for a future randomised controlled trial (RCT).DesignA single-blinded randomised controlled feasibility trial.SettingA specialist outpatient clinic in Sweden.ParticipantsThirty-two adolescents with mild-to-moderate major depression, aged 13-17 years.InterventionsTen weeks of therapist-guided I-BA or self-guided I-BA, or treatment as usual (TAU). Both versions of I-BA included parental support. TAU included referral to usual care within child and youth psychiatry or primary care.OutcomesFeasibility measures included study take-up, participant retention, acceptability, safety and satisfaction. The primary outcome measure was the blinded assessor-rated Children's Depression Rating Scale, Revised. The primary endpoint was the 3-month follow-up.Results154 adolescents were screened and 32 were randomised to therapist-guided I-BA (n=11), self-guided I-BA (n=10) or TAU (n=11). Participant retention was acceptable, with two drop-outs in TAU. Most participants in TAU had been offered interventions by the primary endpoint. The mean number of completed chapters (total of 8) for adolescents was 7.5 in therapist-guided I-BA and 5.4 in self-guided I-BA. No serious adverse events were recorded. Satisfaction was acceptable in both I-BA groups. Following an intent-to-treat approach, the linear mixed-effects model revealed that both therapist-guided and self-guided I-BA (Cohen's d=2.43 and 2.23, respectively), but not TAU (Cohen's d=0.95), showed statistically significant changes on the primary outcome measure with large within-group effect sizes.ConclusionsBoth therapist-guided and self-guided I-BA are acceptable and potentially efficacious treatments for adolescents with depression. It is feasible to conduct a large-scale RCT to establish the efficacy and cost-effectiveness of I-BA versus TAU.Trial registration numberClinicalTrials.gov Registry (NCT04117789).
| S-EPMC9806095 | biostudies-literature