scholarly journals A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e041667
Author(s):  
Darren J Edwards ◽  
Andrew H Kemp
Keyword(s):  
Mental Health ◽  
Mixed Methods ◽  
Video Game ◽  
Emotional Regulation ◽  
Cognitive Skills ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Mental Health Disorder ◽  
Acceptance And Commitment ◽  
Randomised Controlled

IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect to scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder.ObjectiveHere, we propose a protocol for assessing the feasibility of a novel acceptance and commitment therapy (ACT)-based video game for young adults.Methods and analysisThe Medical Research Council (MRC) framework will be used for developing a complex intervention to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for an appropriately powered, randomised controlled trial to be determined.Ethics and disseminationThis study has been approved by the Psychology Department Research Ethics Committee (2020-4929-3923) at Swansea University in the UK. Dissemination activities will involve publications in peer-reviewed journals, presentations at local and national conferences and promotion through social media.Trial registration numberNCT04566042.

scholarly journals A novel ACT-based video game to support mental health through embedded learning: A mixed-methods feasibility study protocol

2020 ◽  
Author(s):  
Darren Edwards ◽  
Andrew Haddon Kemp
Keyword(s):  
Mental Health ◽  
Mixed Methods ◽  
Video Game ◽  
Emotional Regulation ◽  
Cognitive Skills ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Mental Health Disorder ◽  
Mrc Framework ◽  
Serious Video Games

Introduction: In recent years, serious video games have been utilised to promote emotional regulation in individuals with mental health issues. Though these therapeutic strategies are innovative, they are limited in the scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder. Objective: Here, a protocol is proposed, which assesses the feasibility of a novel ACT-based video game for young adults. Methods and analysis: The MRC framework will be utilised for developing a complex intervention, to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance, and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for a full randomized controlled trial to be determined. Ethics and Dissemination: This study has received approval from the College of Human and Health Sciences at Swansea University in the United Kingdom. Dissemination activities will involve publications in peer reviewed journals, presentations at local and national conferences, and promotion through social media.

scholarly journals Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ulrich Reininghaus ◽  
Annelie Klippel ◽  
Henrietta Steinhart ◽  
Thomas Vaessen ◽  
Martine van Nierop ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Daily Life ◽  
Controlled Trial ◽  
Psychotic Experiences ◽  
Intervention Period ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

Abstract Background Psychotic experiences, social functioning and general psychopathology are important targets for early intervention in individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP). Acceptance and Commitment Therapy (ACT) is a promising, next-generation Cognitive Behavioural Therapy (CBT) that aims to modify these targets, but evidence on sustainable change and its underlying mechanisms in individuals’ daily lives remains limited. The aim of the INTERACT study is to investigate the efficacy of a novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL) in a multi-centre randomised controlled trial of individuals with UHR or FEP. Methods/design In a multi-centre randomised controlled trial, individuals aged 16–65 years with UHR or FEP will be randomly allocated to ACT-DL in addition to treatment as usual (TAU) as the experimental condition or a control condition of TAU only, which will include – for the entire study period – access to routine mental health care and, where applicable, CBT for psychosis (CBTp). Outcomes will be assessed at baseline (i.e. before randomisation), post-intervention (i.e. after the 8-week intervention period), and 6-month and 12-month follow-ups (i.e. 6 and 12 months after completing the intervention period) by blinded assessors. The primary outcome will be distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology. Process measures to assess putative mechanisms of change will include psychological flexibility, stress sensitivity and reward experiences. In addition, acceptability, treatment adherence and treatment fidelity of ACT-DL will be assessed. Discussion The current study is the first to test the efficacy of ACT-DL in individuals with UHR and FEP. If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services. Trial registration Netherlands Trial Register, ID: NTR4252. Registered on 26 September 2013.

scholarly journals Development of a casual video game (Match Emoji) with psychological well-being concepts for young adolescents

2021 ◽  
Vol 7 ◽  
pp. 205520762110478
Author(s):  
Russell Pine ◽  
Lisa Te Morenga ◽  
Mitch Olson ◽  
Theresa Fleming
Keyword(s):  
Mental Health ◽  
Video Games ◽  
Video Game ◽  
Controlled Trial ◽  
Well Being ◽  
Learning Theories ◽  
Implicit Processes ◽  
Psychological Well Being ◽  
Randomised Controlled ◽  
Game Developers

Digital interventions for mental health and well-being have been shown to be effective in trials, yet uptake and retention in real-world settings are often disappointing. A more significant impact may be achieved by building interventions that are closer to how target groups use technology to support their own psychological well-being. Casual video games may be poised to offer an opportunity in this area as they are a highly popular activity among young people. We propose that mental health content can be integrated into the explicit content and the implicit processes used in casual video games. In this paper, we describe the design and core processes of Match Emoji, a casual video game designed to support the development of psychological well-being via gameplay and micro-messages. The iterative development of Match Emoji involved various phases, including a systematic review of the literature, consultation with target users, clinicians, game developers, and close reading of the literature. Expert collaboration was sought throughout the process to ensure gameplay and messages matched behaviour change and learning theories. An acceptability and feasibility study of Match Emoji will inform a randomised controlled trial in the future.

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

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 Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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