scholarly journals A feasibility hybrid II randomised controlled trial of volunteer ‘Health Champions’ supporting people with serious mental illness manage their physical health: study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Julie Williams ◽  
Elliann Fairbairn ◽  
Ray McGrath ◽  
Ioannis Bakolis ◽  
Andy Healey ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Mental Health Services ◽  
Health Services ◽  
Physical Health ◽  
Controlled Trial ◽  
Unintended Consequences ◽  
Mental Illnesses ◽  
Feasibility Trial ◽  
Randomised Controlled

Abstract Background People with serious mental illnesses (SMI) such as schizophrenia often also have physical health illnesses and interventions are needed to address the resultant multimorbidity and reduced life expectancy. Research has shown that volunteers can support people with SMI. This protocol describes a feasibility randomised controlled trial (RCT) of a novel intervention involving volunteer ‘Health Champions’ supporting people with SMI to manage and improve their physical health. Methods This is a feasibility hybrid II randomised effectiveness-implementation controlled trial. The intervention involves training volunteers to be ‘Health Champions’ to support individual people with SMI using mental health services. This face-to-face or remote support will take place weekly and last for up to 9 months following initial introduction. This study will recruit 120 participants to compare Health Champions to treatment as usual for people with SMI using secondary community mental health services in South London, UK. We will measure the clinical and cost effectiveness including quality of life. We will measure the implementation outcomes of acceptability, feasibility, appropriateness, fidelity, barriers and enablers, unintended consequences, adoption and sustainability. Discussion There is a need for interventions to support people with SMI with their physical health. If this feasibility trial is successful, a definitive trial will follow to fully evaluate the clinical, cost and implementation effectiveness of Health Champions supporting people with SMI. Trial registration ClinicalTrials.gov, registration no: NCT04124744.

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.

Effectiveness of health checks to improve the physical health of people with severe mental illness in secondary care: A single blind cluster randomised controlled trial

2017 ◽  
Vol 41 (S1) ◽  
pp. S390-S391
Author(s):  
J. White ◽  
J. Lucas ◽  
L. Swift ◽  
G. Barton ◽  
G. Harriet ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Secondary Care ◽  
Controlled Trial ◽  
Well Being ◽  
Health Checks ◽  
Randomised Controlled ◽  
Single Blind

IntroductionAnnual monitoring of physical health of people with severe mental illness (SMI) in primary or secondary care is recommended in England.ObjectiveThe SMI Health Improvement Profile (HIP) was developed to target physical well-being in SMI through the role of the mental health nurse.AimThe primary aim was to investigate if health checks performed by community mental health nurses (CMHNs) trained to use the HIP improved the physical well-being of patients with SMI at 12 months.MethodsA single blind, parallel group randomised controlled trial of training to use the HIP (clustered at the level of the nurse). Physical well-being was measured in study patients using the physical component score of the SF36v2 at baseline and at 12 months.ResultsSixty CMHNs (working with 173 patients) were assigned to the HIP programme (training to use the HIP) or treatment as usual. The HIP was completed with 38 (42%) patients at baseline and 22 (24%) at follow-up in the HIP programme group. No effect of the HIP programme on physical health-related quality of life of study patients was identified, a finding supported by per protocol analyses.ConclusionsThis study found no evidence that CMHN delivered health checks following training to use the HIP are effective at improving the physical well-being of SMI patients at one year. More attention to methods that aim to enable the delivery, receipt and enactment of evidence-based interventions to improve physical health outcomes in this population is urgently required.ISRCTN: 41137900.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Describing a principles-based approach to developing and evaluating peer worker roles as peer support moves into mainstream mental health services

2017 ◽  
Vol 21 (3) ◽  
pp. 133-143 ◽  
Author(s):  
Steve Gillard ◽  
Rhiannon Foster ◽  
Sarah Gibson ◽  
Lucy Goldsmith ◽  
Jacqueline Marks ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Services ◽  
Health Services ◽  
Lived Experience ◽  
Peer Support ◽  
Research Team ◽  
Controlled Trial ◽  
Content Type ◽  
Value Sets ◽  
Randomised Controlled

Purpose Peer support is increasingly being introduced into mainstream mental health services internationally. The distinctiveness of peer support, compared to other mental health support, has been linked to values underpinning peer support. Evidence suggests that there are challenges to maintaining those values in the context of highly standardised organisational environments. The purpose of this paper is to describe a “principles-based” approach to developing and evaluating a new peer worker role in mental health services. Design/methodology/approach A set of peer support values was generated through systematic review of research about one-to-one peer support, and a second set produced by a UK National Expert Panel of people sharing, leading or researching peer support from a lived experience perspective. Value sets were integrated by the research team – including researchers working from a lived experience perspective – to produce a principles framework for developing and evaluating new peer worker roles. Findings Five principles referred in detail to: relationships based on shared lived experience; reciprocity and mutuality; validating experiential knowledge; leadership, choice and control; discovering strengths and making connections. Supporting the diversity of lived experience that people bring to peer support applied across principles. Research limitations/implications The principles framework underpinned development of a handbook for a new peer worker role, and informed a fidelity index designed to measure the extent to which peer support values are maintained in practice. Given the diversity of peer support, the authors caution against prescriptive frameworks that might “codify” peer support and note that lived experience should be central to shaping and leading evaluation of peer support. Originality/value This paper adds to the literature on peer support in mental health by describing a systematic approach to understanding how principles and values underpin peer worker roles in the context of mental health services. This paper informs an innovative, principles-based approach to developing a handbook and fidelity index for a randomised controlled trial. Lived experiences of mental distress brought to the research by members of the research team and the expert advisors shaped the way this research was undertaken.

scholarly journals Promoting physical activity in vulnerable adults ‘at risk’ of homelessness: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026466 ◽  
Author(s):  
Charlotte Stringer ◽  
Mike Loosemore ◽  
Eloise Moller ◽  
Sarah E Jackson ◽  
Guillermo Felipe López-Sánchez ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
At Risk ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
The Impact ◽  
Mental And Physical Health

IntroductionPeople who are homeless, or at risk of homelessness, have substantially poorer health. Sustained and regular participation in physical activity is beneficial for both mental and physical health. Limited data suggest that levels of physical activity in the homeless and those at risk of homelessness are low, and access to community-based exercise is limited or non-existent for this population. Nonetheless, exercise programmes for the homeless could provide a feasible and scalable intervention for providing beneficial effects on physical and mental health in this population. The primary aim of this study is to evaluate the impact of a group exercise intervention on activity levels in people who are homeless or at risk of homelessness in central London, UK. The secondary aim is to evaluate the impact of the intervention on mental and physical health outcomes.Method and analysisA 2-arm, individually randomised controlled trial in people who are homeless and those vulnerable and at risk of homelessness in central London, UK. Participants will be recruited through a London-based homeless charity, Single Homeless Project. Following baseline assessments and allocation to intervention (exercise classes) or control (usual care), participants will be followed up at 3, 6, 9 and 12 months. The primary outcomes will be change in objective physical activity. The secondary outcomes will include change in fitness assessments and mental health parameters. Changes in drug use and alcohol dependency will also be explored.Ethics and disseminationEthical approval to process and analyse data and disseminate findings was obtained through the Anglia Ruskin University Department of Sport and Exercise Sciences Research Ethics Committee. Results of this study will be disseminated through peer-reviewed publications and scientific presentations.

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

2021 ◽  
pp. 1-14
Author(s):  
Nina Reinholt ◽  
Morten Hvenegaard ◽  
Anne Bryde Christensen ◽  
Anita Eskildsen ◽  
Carsten Hjorthøj ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Services ◽  
Health Services ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Major Depressive ◽  
Outpatient Mental Health ◽  
End Of Treatment

<b><i>Introduction:</i></b> The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. <b><i>Objective:</i></b> This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. <b><i>Methods:</i></b> In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. <b><i>Results:</i></b> At end-of-treatment, WHO-5 mean scores for patients in UP (<i>n</i> = 148) were non-inferior to those of patients in dCBT (<i>n</i> = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. <b><i>Conclusions:</i></b> This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

2021 ◽  
Vol 18 (12) ◽  
pp. 6306
Author(s):  
Aitana García-Estela ◽  
Natalia Angarita-Osorio ◽  
Sandra Alonso ◽  
Maria Polo ◽  
Maria Roldán-Berengué ◽  
...  
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Controlled Trial ◽  
Exercise Group ◽  
Global Functioning ◽  
Motivational Messages ◽  
Randomised Controlled ◽  
Group Programme

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

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