scholarly journals Development and Evaluation of a Digital Health Intervention for Substance Use Reduction in Young Refugees With Problematic Use of Alcohol and/or Cannabis—Study Protocol for a Single-Armed Feasibility Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Laura Charlotte Fischer ◽  
Vera Kölligan ◽  
Nuri Wieland ◽  
Michael Klein
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Digital Health ◽  
Health Intervention ◽  
Target Group ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Problematic Use ◽  
Digital Interventions

Background: Refugee populations are at substantial risk of developing substance use disorder (SUD) and other mental health disorders. At the same time, refugee populations face numerous barriers to accessing mental health services. Digital interventions can address some of these issues, as emerging evidence indicates that digital interventions offer an effective, low-cost alternative with high accessibility and similar efficacy as standard SUD prevention programs. As an add-on to traditional services, they further present a viable approach to the lack of personnel available for foreign language communication in preventive and therapeutic settings. In the present study, we thus aim to develop and evaluate a digital health intervention (DHI) for the reduction of substance use for young refugees with problematic use of alcohol and/or cannabis. The intervention will be implemented in a smartphone app, translated into Arabic, English, Farsi, German, and Pashto, and is to be used stand-alone. It is based on methods from cognitive behavioral therapy, contains culturally adapted elements, provides practical information on how to deal safely with alcohol and cannabis, and motivates behavior change through increased self-reflection and behavioral, cognitive, and emotional skills-training in interactive exercises.Methods: We conduct a single-armed feasibility trial among 150 young refugees with problematic use of alcohol and/or cannabis. Participants will receive a digital screening and digital health intervention (DHI) for the reduction of problematic substance use, carried out over a 4-week time frame. The primary outcomes are the intervention's feasibility and the target population's acceptance of the intervention. The secondary outcome is a change in substance use post-intervention from baseline. Measurements are taken pre-intervention (baseline), post-intervention (after 4 weeks), and at 3- and 6-month follow-ups. We expect the intervention to be feasible and accepted by the target group.Discussion: The present study will establish to what degree the digital intervention (the “BePrepared App”) is feasible and accepted by the target group. The evaluation of an easily accessible, feasible, and accepted intervention may impact refugees' mental health and health-related consequences. It aims at overcoming barriers to preventive health care in the substance use field for underserved refugee populations as a tool within a larger set of urgently needed interventions.Trial Registration: DRKS00021095 at the “German Clinical Trials Register” (30.03.2020).

scholarly journals Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e045235
Author(s):  
Felicity Waite ◽  
Thomas Kabir ◽  
Louise Johns ◽  
Jill Mollison ◽  
Apostolos Tsiachristas ◽  
...  
Keyword(s):  
Mental Health ◽  
High Risk ◽  
Young People ◽  
Sleep Problems ◽  
Qualitative Interviews ◽  
Feasibility Trial ◽  
Psychotic Experiences ◽  
Post Intervention ◽  
Ultra High Risk ◽  
Randomised Controlled

BackgroundEffective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysisA randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and disseminationThe trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration numberISRCTN85601537.

scholarly journals Preliminary Evaluation of the Engagement and Effectiveness of a Mental Health Chatbot

2020 ◽  
Author(s):  
Kate Daley
Keyword(s):  
Mental Health ◽  
Digital Health ◽  
Preliminary Evaluation ◽  
Real World Data ◽  
Post Intervention ◽  
Middle Income ◽  
Middle Income Countries ◽  
Cohen’S D ◽  
Cohen's D ◽  
Human Support

Background: Mental health difficulties are highly prevalent yet access to support is impeded by barriers of stigma, cost and availability. These issues are even more prevalent in low- and middle-income countries, and use of digital technology is one way to overcome these barriers. Digital health interventions have been shown to be effective but often struggle with low engagement rates, particularly in the absence of any human support. Chatbots could offer a scalable solution, simulating human support at a lower cost. Objective: To complete a preliminary evaluation of engagement and effectiveness of Vitalk, a mental health chatbot, at reducing anxiety, depression and stress. Methods: Real world data was analysed from 3629 Vitalk users who had completed the first phase of a Vitalk program (‘less anxiety’, ‘less stress’ or ‘better mood’). Programs were delivered through written conversation with the chatbot. Engagement was calculated from the number of responses sent to the chatbot divided by days in the program. Results: Users sent an average of 8.17 responses / day. For all three programs, target outcome scores reduced between baseline and follow up with large effect sizes for anxiety (Cohen's d = -0.85), depression (Cohen's d = -0.91) and stress (Cohen's d =-0.81). Increased engagement resulted in improved post-intervention values for anxiety and depression. Conclusion: This study highlights the potential of a chatbot to reduce mental health symptoms in the general population within Brazil. Whilst findings show promise, further research is required.

Supporting mental health during COVID-19 using a digital behaviour change intervention: an open-label, single-arm, pre-post intervention research study (Preprint)

2021 ◽  
Author(s):  
Charlotte Summers ◽  
Philip Wu
Keyword(s):  
Mental Health ◽  
Behaviour Change ◽  
Perceived Stress ◽  
Digital Health ◽  
Mental Wellbeing ◽  
Behaviour Change Intervention ◽  
Open Label ◽  
Post Intervention ◽  
Convenience Sample ◽  
Health Technologies

BACKGROUND COVID-19 is taking its toll on people's mental health, particularly as people are advised to adhere to social distancing, self-isolation measures and government imposed national lockdowns. Digital health technologies have an important role to play in keeping people connected and supporting mental health and wellbeing. Particularly in the wake of the COVID-19 pandemic as even before this unprecedented time, mental health and social services were already stretched. OBJECTIVE Our objective was to evaluate the 12-week outcomes of the digitally delivered Gro Health platform, a digital behaviour change intervention for self-management of mental wellbeing, sleep, activity, and nutrition. METHODS The study used a quasi-experimental research design consisting of an open-label, single-arm, pre-post intervention engagement using a convenience sample. From adults who had joined the intervention and had a complete baseline dataset (GAD-7 Anxiety Test Questionnaire, Perceived Stress Scale, PHQ-9 Patient Health Questionnaire), we followed all users for 12 weeks (N=273), including 33 (12.1%) who reported a positive COVID-19 diagnosis during the study period. Users engagement with the Gro Health platform was tracked by active minutes. RESULTS Of the 347 study participants, 273 (78.67%) completed both baseline and follow up surveys. Change in scores for anxiety, perceived stress and depression was predicted by app engagement with the strongest effect being seen in change perceived stress scores F(1,271)=251.397, p<0.001, with an R2 of .479. CONCLUSIONS A digital behaviour change platform that provides remote mental wellbeing support can be effective in managing depression, anxiety, and perceived stress during times of crisis such as the current COVID-19 pandemic. CLINICALTRIAL Approved by Royal Holloway, University of London Ethics Board.

scholarly journals Protocol of a feasibility trial for an online group parenting intervention with an integrated mental health component for parent refugees and asylum-seekers in the United Kingdom: (LTP + EMDR G-TEP)

2021 ◽  
Vol 9 ◽  
pp. 205031212110678
Author(s):  
Safa Kemal Kaptan ◽  
Filippo Varese ◽  
Betul Yilmaz ◽  
Panoraia Andriopoulou ◽  
Nusrat Husain
Keyword(s):  
Mental Health ◽  
Asylum Seeker ◽  
Asylum Seekers ◽  
Parenting Intervention ◽  
Feasibility Trial ◽  
Control Group ◽  
Parental Mental Health ◽  
Post Intervention ◽  
Poor Growth ◽  
Refugees And Asylum Seekers

Objectives: Conflicts expose families to a range of factors that could have a negative impact upon parental mental health which in turn leads to poor growth and development of children. Early support can improve parental mental health and parenting behaviours but currently, there is a lack of evidence on parenting interventions for forcibly displaced populations. This study aims to deliver an online parenting intervention with a mental health component for refugee and asylum-seeker parents to evaluate its feasibility and acceptability. Methods: This is a single-arm trial without a control group. The trial aims to recruit 14 refugee and asylum-seeker parents into an Online Learning Through Play and Eye Movement Desensitization and Reprocessing Group Traumatic Episode Protocol (LTP + EMDR G-TEP). The intervention will be delivered by trained research team members using online platforms. Results: The participants’ sense of parenting competence, symptoms of traumatic stress, anxiety and depression will be measured at baseline and post-intervention. Semi-structured interviews at post-intervention will also be conducted. Discussion: This study will assess the feasibility and inform the design of a future randomized controlled trial which aims to evaluate the effectiveness of LTP + EMDR G-TEP intervention for parent refugees and asylum-seekers with young children.

Strengthening the Impact of Digital Cognitive Behavioral Interventions through a Dual Intervention: Motivational Interviewing Coaching Protocol Plus In-Application Techniques (Preprint)

2021 ◽  
Author(s):  
Catherine Serio ◽  
Amanda Gabarda ◽  
Fatma Uyar-Morency ◽  
Valerie Silfee ◽  
Justin Ludwig ◽  
...  
Keyword(s):  
Mental Health ◽  
Motivational Interviewing ◽  
Clinical Outcomes ◽  
Behavioral Interventions ◽  
Digital Health ◽  
Cognitive Behavioral ◽  
Digital Interventions ◽  
Message Exchange ◽  
Cognitive Behavioral Interventions ◽  
The Impact

BACKGROUND The COVID-19 pandemic has accelerated the adoption of digital tools to support individuals struggling with their mental health. The use of a digital intervention plus human coaching (“dual” intervention) is gaining momentum to increase overall engagement in digital cognitive behavioral interventions (dCBIs). However, there is limited insight about the methodologies and coaching models used by those deploying dual interventions. To achieve a deeper understanding, we need to identify and promote effective engagement that leads to clinical outcomes, versus simply monitoring engagement metrics. Motivational Interviewing (MI) is a collaborative, goal-oriented communication approach with particular attention to the language of change and an effective engagement approach for helping people manage mental health issues. However, this approach has been traditionally used in in-person or telephonic interventions and less is known about the application of MI to digital interventions. OBJECTIVE We sought to provide a dual intervention approach and address multiple factors across two levels to operationalize a dCBI that combined: (1) Cognitive behavioral therapy (CBT)-based techniques; and (2) MI-based interactions between the digital health coach (DHC) and user. METHODS We reviewed hundreds of digital exchanges between DHCs and users to identify and improve training and quality assurance activities for digital interventions. RESULTS We tested five hypotheses and found that: (1) users of a dual digital behavioral health intervention had greater engagement levels than users of a non-coached intervention (p<0.0001); (2) DHCs with a demonstrated competency in applying MI to digital messages had more engaged users, as measured by DHC-to-user message exchange ratio (p<0.001); (3) DHC-to-user message exchange ratio was correlated with more engagement in app activities (r = 0.28 (95% CI [0.23,0.33])); (4) DHCs with demonstrated MI proficiency elicited greater amount of “change talk” from users than did DHCs without MI proficiency (H = 25.12, p<0.0001); and (5) users who were engaged by DHCs with MI proficiency had better clinical outcomes compared to users engaged by DHCs without MI proficiency (p= 0.0151). CONCLUSIONS This data indicates potential and need for further research in establishing coaching models in dCBIs that incorporate MI to promote effective engagement and optimize positive behavioral outcomes.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Online single-session interventions for Kenyan adolescents: study protocol for a comparative effectiveness randomised controlled trial

2021 ◽  
Vol 34 (3) ◽  
pp. e100446
Author(s):  
Akash R Wasil ◽  
Tom Lee Osborn ◽  
John R Weisz ◽  
Robert J DeRubeis
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Comparative Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Single Session ◽  
Post Intervention ◽  
Digital Interventions ◽  
Randomised Controlled

BackgroundMental health problems are the leading cause of disability among adolescents worldwide, yet access to treatment is limited. Brief digital interventions have been shown to improve youth mental health, but little is known about which digital interventions are most effective.AimsTo evaluate the effectiveness of two digital single-session interventions (Shamiri-Digital and Digital-CBT (cognitive-behavioural therapy)) among Kenyan adolescents.MethodsWe will perform a school-based comparative effectiveness randomised controlled trial. Approximately 926 Kenyan adolescents will be randomly assigned to one of three conditions: Shamiri-Digital (focused on gratitude, growth mindsets and values), Digital-CBT (focused on behavioural activation, cognitive restructuring and problem solving) or a study-skills control condition (focused on note-taking and essay writing skills). The primary outcomes include depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (Generalized Anxiety Disorder Screener-7) and subjective well-being (Short Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes include acceptability, appropriateness, primary control and secondary control. Acceptability and appropriateness will be measured immediately post-intervention; other outcomes will be measured 2 weeks, 4 weeks and 12 weeks post-intervention.ResultsWe hypothesise that adolescents assigned to Shamiri-Digital and adolescents assigned to Digital-CBT will experience greater improvements (assessed via hierarchical linear models) than those assigned to the control group. We will also compare Shamiri-Digital with Digital-CBT, although we do not have a preplanned hypothesis.ConclusionsOur findings will help us evaluate two digital single-session interventions with different theoretical foundations. If effective, such interventions could be disseminated to reduce the public health burden of common mental health problems.Trial registration numberPACTR202011691886690.

scholarly journals SOLACE: A Psychosocial Stigma Protection Intervention to Improve the Mental Health of Parents of Autistic Children—A Feasibility Randomised Controlled Trial

2020 ◽  
Vol 50 (12) ◽  
pp. 4477-4491 ◽  
Author(s):  
Annemarie Lodder ◽  
Chris Papadopoulos ◽  
Gurch Randhawa
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Autistic Children ◽  
Self Compassion ◽  
Group Interviews ◽  
Randomised Controlled

AbstractThis study presents findings from a feasibility trial, testing an 8-week psychosocial stigma protection intervention (SOLACE) designed to improve the mental health of parents of autistic children. Seventeen parents were stratified then randomly assigned to either SOLACE (n = 9) or control group (n = 8). Retention and adherence rates were excellent with minimal missing data suggesting SOLACE had good acceptability and feasibility. Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants. In addition, changes in secondary outcome measures (e.g. stigma, self-esteem and self-compassion) were in favour of SOLACE. Focus group interviews revealed that SOLACE was acceptable to parents. Results suggest that a full randomised controlled trial is warranted.

scholarly journals Feasibility of a Digital Health Intervention to Improve Diet Quality Among Women With High Blood Pressure: Randomized Controlled Feasibility Trial (Preprint)

2019 ◽  
Author(s):  
Dori M Steinberg ◽  
Melissa C Kay ◽  
Laura P Svetkey ◽  
Sandy Askew ◽  
Jacob Christy ◽  
...  
Keyword(s):  
Blood Pressure ◽  
High Blood Pressure ◽  
Digital Health ◽  
Population Level ◽  
Health Intervention ◽  
Text Messages ◽  
Feasibility Trial ◽  
Dash Score ◽  
Active Comparator ◽  
Randomized Controlled

BACKGROUND Over 100 million individuals have high blood pressure, and more than half of them are women. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is a proven lifestyle approach to lower blood pressure, yet population-level adherence is poor. Innovative strategies that promote DASH are needed. OBJECTIVE This paper aims to improve adherence to the DASH diet among women with hypertension or prehypertension. METHODS We conducted a 3-month randomized controlled feasibility trial comparing app-based diet tracking (active comparator) to app-based diet tracking plus feedback on DASH adherence via text message (intervention). The intervention platform extracted nutrient data from the app, compared it to DASH recommendations, and sent tailored feedback text messages. Outcomes included the number of days participants tracked their diet, changes in their DASH adherence score, and blood pressure. RESULTS The women (N=59) had a mean age of 49.9 (SD 11.9) years and were primarily non-Hispanic White (41/59, 69%) and college educated (49/59, 83%). The mean baseline DASH score was 2.3 (SD 1.3). At 3 months, the intervention and active comparator participants had similar mean days tracked per week (4.2, SD 2.1 days vs 4.6, SD 2.7 days; <i>P</i>=.54) and mean changes in their DASH score (0.8, 95% CI 0.2-1.5 vs 0.8, 95% CI 0.4-1.2; <i>P</i>=.75). Intervention participants had lower systolic (mean difference: –2.8 mmHg, 95% CI –1.8 to 7.4; <i>P</i>=.23) and diastolic (mean difference: –3.6 mmHg, 95% CI –0.2 to 7.3; <i>P</i>=.07) blood pressure compared with active comparator participants. Most intervention participants (23/29, 79%) said they would recommend the DASH Cloud intervention to a friend or family member. However, only 34% (10/59) indicated that the feedback text messages helped them reach their diet goals. CONCLUSIONS A digital health intervention to improve DASH adherence is feasible and produces moderately high engagement among women with elevated blood pressure. The intervention did not enhance DASH adherence over diet tracking alone but resulted in greater reductions in blood pressure. Larger studies are needed to determine how digital health interventions can improve population-level adherence to DASH. CLINICALTRIAL ClinicalTrials.gov NCT03215472; https://clinicaltrials.gov/ct2/show/study/NCT03215472

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