scholarly journals Protocol for the RELATE trial: a feasibility and pilot randomised controlled trial of a low-intensity group intervention for young people in care with elevated posttraumatic stress symptoms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rachel M. Hiller ◽  
Rebecca S. Davis ◽  
John Devaney ◽  
Sarah L. Halligan ◽  
Richard Meiser-Stedman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Posttraumatic Stress ◽  
Group Intervention ◽  
Social Care ◽  
Controlled Trial ◽  
Good Evidence ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Introduction Young people in out-of-home care have often experienced trauma, such as direct maltreatment or witnessing violence. There is good evidence that rates of mental health difficulties are high in this group, including posttraumatic stress disorder (PTSD), a trauma-specific mental health outcome. There remains less evidence to guide how to effectively address elevated PTSD symptoms (PTSS) in these young people, particularly in ways that are feasible and scalable for stretched social-care and mental health services. Methods and analysis This protocol describes a feasibility study comprising a pilot two-arm randomised controlled trial (RCT). Participants (N = 50) will be randomised to either (a) a group-based trauma-focused programme (Teaching Recovery Techniques), delivered by mental health practitioners both online and in-person, or (b) care-as-usual. Primarily, the trial aims to explore the key feasibility and protocol acceptability questions, including rates of recruitment and retention, as well as the acceptability of the intervention (particularly the online delivery format) to participants and services. In addition, outcomes including PTSS (primary clinical outcome), depression and functioning will be assessed at baseline (pre-randomisation), post-intervention and at a 3-month follow-up. Ethics and dissemination Ethical approval has been received from the Health Research Authority (Wales REC1 Ref 20/WA/0100) and University, with further approval from the host trust and social care site. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries. Trial registration ClinicalTrials.gov, NCT04467320. Registered on 13 July 2020.

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.

scholarly journals Mixed methods pilot evaluation of interpersonal psychotherapy for body image for adolescents

2020 ◽  
pp. 135910452096337
Author(s):  
Fiona Duffy ◽  
Helen Sharpe ◽  
Emily Beveridge ◽  
Kate Osborne ◽  
Cathy Richards
Keyword(s):  
Body Image ◽  
Young People ◽  
Body Dissatisfaction ◽  
Clinical Outcomes ◽  
Group Intervention ◽  
Treatment Satisfaction ◽  
Controlled Trial ◽  
Interpersonal Psychotherapy ◽  
Post Intervention ◽  
Randomised Controlled

Body dissatisfaction is common in adolescence and associated with poor outcomes. The aim of this mixed method pilot evaluation was to determine acceptability, feasibility and preliminary efficacy of Interpersonal Psychotherapy for Body Image (IPT-BI), a school-based group intervention for young people with high levels of body dissatisfaction. Eighteen participants (11–13 years, 78% female) took part in two IPT-BI groups ( n = 10; n = 8). Feasibility was measured by recruitment and attrition rates; acceptability using a treatment satisfaction questionnaire and focus groups; and clinical outcomes at baseline, each session and post intervention. The majority of young people (72%, n = 18/25) who were referred or expressed interest went on to take part. Average session attendance was 100% and 89%. Participants expressed high levels of treatment satisfaction with 94% ( n = 16/17) rating IPT-BI as ‘quite helpful’ or ‘very helpful’ and 94% ( n = 16/17) stating they would recommend it to others. Preliminary exploration of efficacy showed significant improvements in body image and significant reductions in interpersonal difficulties and appearance-based conversations. Young people valued specific IPT-BI skills (role play, communication strategies), alongside generic therapeutic factors (therapeutic alliance, group cohesion). IPT-BI is feasible and acceptable with promising provisional clinical outcomes indicating the need for a fully powered randomised controlled trial.

scholarly journals A Pilot Randomised Controlled Trial of the Peer Tree Digital Intervention Targeting Loneliness Iin Young People: A Study Protocol

2021 ◽  
Author(s):  
Michelle H Lim ◽  
Lily Thurston ◽  
Robert Eres ◽  
Thomas L Rodebaugh ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Social Anxiety ◽  
Young People ◽  
Positive Psychology ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Pilot Randomised Controlled Trial ◽  
Positive Psychology Interventions ◽  
Randomised Controlled

Abstract Background: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strengths-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness, and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. Methods: This will be a pilot randomised controlled trial (RCT) comparing a strengths-based digital smartphone application (Peer Tree) with a treatment as usual (TAU) condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidality risk, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, post-intervention, and at follow-up. Participants in the TAU condition complete the same three assessment sessions. The primary outcomes of the study will be self-reported loneliness as well as the acceptability, usability, feasibility and safety of Peer Tree. Depression, social anxiety, and quality of life variables will also be measured as secondary outcomes. Discussion: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN12619000350123. Registered 6th March 2020

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 Interpersonal Counselling for Adolescent Depression delivered by Youth Mental Health Workers without Core Professional Training: A Feasibility Randomised Controlled Trial study protocol

2020 ◽  
Author(s):  
Gabriel Abotsie ◽  
Viktoria Cestaro ◽  
Brioney Gee ◽  
Jamie Murdoch ◽  
Thando Katangwe ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Process Evaluation ◽  
Professional Training ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
Specialist Services ◽  
Randomised Controlled

Abstract Background: Depression is a common health problem during adolescence and is associated with adverse academic, social and health outcomes. To meet demand for treatment for adolescent depression, there is a need for evidence-based interventions suitable for delivery outside of specialist Child and Adolescent Mental Health Services (CAMHS). Interpersonal Counselling for Adolescents (IPC-A), is a brief manualised intervention for adolescent depression suitable for delivery by staff who are not qualified health professionals following participation in a brief training course. While initial piloting within Local Authority services has generated promising results, the effectiveness and cost-effectiveness of IPC-A has yet to be established. This study aims to assess the feasibility of a randomised controlled trial (RCT), evaluating the effectiveness and cost-effectiveness of IPC-A delivered by staff without core professional training in comparison to current provision. Method: Feasibility RCT with process evaluation using ethnographic methodology. Eligible young people (n=60) will be randomised in a 1:1 ratio to receive either IPC-A or treatment as usual (TAU). Participants will be assessed pre-randomisation (baseline) and followed up at 5, 10 and 23 weeks post-randomisation. A parallel process evaluation will generate understanding of intervention implementation across services and explore the acceptability of the intervention from the perspective of young people and other key stakeholders.Participants: Young people aged 12-18 years presenting to non-specialist services with symptoms of depression. Youth workers, young people and stakeholders will participate in the process evaluation.Discussion: The need for effective and accessible interventions for young people with mild/sub-threshold depression who in most cases, do not meet the threshold for mainstream mental health services is long overdue. The primary output of this feasibility trial will be the design of the subsequent full-scale trial. If the results of the current study indicate that this would be feasible, we intend to progress to a multi-site, assessor-blind, superiority RCT of the effectiveness and cost-effectiveness of IPC-A in comparison to TAU for adolescents presenting to non-specialist services with depressive symptoms. If satisfactory solutions to any problems encountered cannot be identified, alternative research designs will be considered. If proven effective, an IPC-A training programme could be implemented.Trial registry: ISRCTN registry, ISRCTN82180413. Registered 31 December 2019, https://doi.org/10.1186/ISRCTN82180413

scholarly journals 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 ◽  
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

scholarly journals 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

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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