Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial

IntroductionAdolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.Methods and analysisA two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.Ethics and disseminationThe study was approved by the Swedish Ethical Review Authority (no. 2019–03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.Trial registration number24 September 2019, ISRCTN91048246; Pre-results.

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A cultural experience to support mental health in people aged 16–24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial

Trials ◽

10.1186/s13063-021-05441-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Rebecca J. Syed Sheriff ◽

Matti Vuorre ◽

Evgenia Riga ◽

Andrew K. Przybylski ◽

Helen Adams ◽

...

Keyword(s):

Mental Health ◽

Young Adults ◽

Randomised Controlled Trial ◽

Young People ◽

Common Mental Disorders ◽

Controlled Trial ◽

Cultural Experience ◽

High Prevalence ◽

Randomised Controlled ◽

Ways Of Being

Abstract Background Despite the high prevalence of common mental disorders in adolescents and young adults, and their association with poor health and socio-economic outcomes throughout the lifespan, many young people do not seek or receive help for such disorders. There is growing interest in the community sector in supporting mental health in young people; however, there is little by way of experimental research in this area. During the COVID-19 pandemic and lockdown, we designed an online cultural experience to reduce anxiety and depression and support mental health in people aged 16–24. Methods/design The O-ACE POP (Online Active Community Engagement Proof of Principle) study is a UK-based online randomised controlled trial of an online cultural experience named Ways of Being, involving human centred narratives and viewpoints, compared with a typical museum website (the Ashmolean Museum). We aim to compare efficacy on affect, symptoms of epression and anxiety, flourishing and loneliness as well as investigating potential mechanisms of action. Discussion The COVID-19 pandemic has provided a unique opportunity to design an innovative approach to supporting mental health in young adults. Findings derived from this study will allow us to evaluate the efficacy of this intervention and will inform the design of studies to further refine the resource and test it further. Trial registration ClinicalTrials.gov NCT04663594. Registered on 11 December 2020 (submitted in same form 27 November 2020). Protocol v1.0: 27 November 2020. Date recruitment began: 4 December 2020. Recruitment complete (estimate): February 2021

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A Cultural Experience to support Mental Health in People Aged 16-24 During COVID-19 Compared to a Typical Museum Website: Study Protocol of an Online Randomised Controlled Trial

10.21203/rs.3.rs-181910/v1 ◽

2021 ◽

Author(s):

Rebecca Syed Sheriff ◽

Matti Vuorre ◽

Evgenia Riga ◽

Andrew K Przybylski ◽

Helen Adams ◽

...

Keyword(s):

Mental Health ◽

Young Adults ◽

Randomised Controlled Trial ◽

Young People ◽

Common Mental Disorders ◽

Controlled Trial ◽

Cultural Experience ◽

High Prevalence ◽

Randomised Controlled ◽

Ways Of Being

Abstract Background: Despite the high prevalence of common mental disorders in adolescents and young adults, and their association with poor health and socio-economic outcomes throughout the lifespan, many young people do not seek or receive help for such disorders. There is growing interest in the community sector in supporting mental health in young people, however, there is little by way of experimental research in this area. During the COVID-19 pandemic and lockdown we designed an online cultural experience to reduce anxiety and depression and promote positive mental health in people aged 16-24. Methods/design: The O-ACE POP (Online Active Community Engagement Proof of Principle) study is a randomised controlled trial of an online cultural experience named Ways of Being, based on human centred narratives and viewpoints, compared with a typical museum website (the Ashmolean Museum). We aim to compare efficacy on mood, distress (depression and anxiety), flourishing and loneliness as well as investigating potential mechanisms of action, and feasibility of a larger scale RCT. Discussion: COVID-19 has provided a unique opportunity to design an innovative approach to supporting mental health in young adults. Findings derived from this study will allow us to evaluate the efficacy of this intervention and will inform the design of studies to further refine the resource and test it further.Trial StatusTrial Registration: NCT04663594First Registered: 11th Dec 2020 (submitted in same form 27th Nov 2020)Protocol v1.0: 3rd Dec 2020Date recruitment began: 4th Dec 2020Recruitment complete (estimate): Feb 2021

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Effect of an Economic Transfer Program on Mental Health of Displaced Persons and Host Populations in Democratic Republic of Congo: A Randomised Controlled Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3706054 ◽

2020 ◽

Author(s):

John Quattrochi ◽

Ghislain Bisimwa ◽

Peter Van der Windt ◽

Maarten Voors

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Democratic Republic ◽

Democratic Republic Of Congo ◽

Controlled Trial ◽

Displaced Persons ◽

Transfer Program ◽

Republic Of Congo ◽

Randomised Controlled

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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 ◽

10.1136/bmjopen-2021-050661 ◽

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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