Dataset Information

One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.

ABSTRACT:

Introduction

People with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with an active control group.

Methods and analysis

The trial aims to recruit 40 participants with ID. Participants in the intervention arm will receive weekly visits from a volunteer over 6?months. Community befriending schemes will recruit, train, supervise volunteers and match them to individuals with ID. Both groups will receive a booklet about local activities and have access to usual care. Health and social outcomes will be measured at the end of the intervention and 6 months' follow-up. The following outcomes will be assessed: (1) recruitment and retention of individuals with ID and volunteers in the trial, (2) adverse events related to the intervention, (3) the acceptability of the intervention, (4) whether the intervention is delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis in a full trial. Qualitative data from participants, volunteers, staff and carers will identify barriers and facilitators of a future full trial.

Ethics and dissemination

The study has been approved by the London City and East Research Ethics Committee (reference 18/LO/2188). The findings will be presented at conferences and published in a peer-reviewed journal and in the National Institute of Health Research journals library. A public engagement seminar will be held at the end of the study aimed at key stakeholders.

Trial registration number

ISRCTN63779614.

SUBMITTER: Ali A

PROVIDER: S-EPMC7311030 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.

Ali Afia A Mckenzie Emma E Hassiotis Angela A Priebe Stefan S Lloyd-Evans Brynmor B Omar Rumana R Jones Rebecca R Panca Monica M Fernandez Vincent V Finning Sally S Moore Shirley S O'Connor Danielle D Roe Christine C King Michael M

BMJ open 20200621 6

<h4>Introduction</h4>People with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with ...[more]

PMID: 32565450

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Project description:BackgroundDespite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention.Methods/designSUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI).DiscussionThis study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial.Trial registrationClinicalTrials.gov identifier NCT02947776, registered 28th October 2016.

Project description:INTRODUCTION:The aim of this review is to answer the following question: Does assistive technology contribute to social inclusion for people with intellectual disability? Previous research on assistive technology has focused on socioeconomic impacts such as education, employment and access to healthcare by people with intellectual disability. There is a need to consolidate evidence on the interaction between intellectual disability, assistive technology, community living and social inclusion. METHODS AND ANALYSIS:The review will consider studies from all settings: geographical, socioeconomic and care (institutional and community care), published in English. Studies reported in other languages with abstracts in English will be included if they can be translated using Google Translate, otherwise such studies will be included in the appendix. The review will include both qualitative and quantitative studies. The intervention in this review refers to the use of assistive technology to promote community participation or interpersonal relationships (social inclusion) for people with intellectual disability. The outcomes will be behavioural and social benefits of using assistive technology by people with intellectual disability. Enhanced interpersonal relationships and community participation by people with intellectual disability. Data analysis will be in two phases. The first phase will involve analysis of individual study designs separately. The second phase will be narrative/thematic synthesis of all study groups. ETHICS:The review will not create any ethical or safety concerns. DISSEMINATION:At least one peer-reviewed article in a leading journal such as the BMJ is planned. The findings will also be disseminated through a seminar session involving internal audience at Trinity College Dublin and within the Assistive Technologies for people with Intellectual Disability and Autism research programme. PROSPERO REGISTRATION NUMBER:CRD42017065447; Pre-results.

Project description:IntroductionSevere behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.Methods and analysisThis is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8-16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.Ethics and disseminationThis protocol has received ethics approval from the Royal Children's Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.Trial registration numberACTRN12618001852246.

Project description:BackgroundThis protocol describes an ongoing study of the impact of befriending on depression, anxiety and loneliness in older people living in residential aged care facilities in Australia. While systematic reviews of befriending have indicated positive benefits of befriending for people in a range of ages and settings, there have been no randomised controlled trials (RCTs) of befriending for older people living in residential aged care with depression and no studies of the cost effectiveness of befriending in residential aged care facilities (RACFs) in Australia.Methods and analysisWe are conducting a single blind pragmatic RCT comparing two groups of older people living in RACFs, one receiving an intervention consisting of weekly befriending for 4 months from a trained volunteer and the other receiving treatment as usual. Participants undergo eligibility screening for depression (GDS-15 ≥ 4) and cognitive impairment (GPCog ≥ 4) and assessments at three measurement time points: baseline prior to randomisation, 2 months post-baseline and 4 months post-baseline. The primary outcome measure is depression, and secondary outcome measures are anxiety, loneliness, social isolation and quality of life. The economic evaluation will take the form of a cost-utility analysis based on the outcome of quality of life. The primary and secondary outcomes will be analysed using negative binomial and logistic regressions utilizing the Generalised Estimating Equations approach.DiscussionTo our knowledge, this is the first RCT evaluating the effectiveness of befriending on older people with depression living in residential aged care. It is expected that the befriending intervention will reduce the severity of depression symptoms experienced by older people living in residential aged care. If the intervention proves effective it may be incorporated into volunteer training programs and adopted as a way of supporting older people's mental health.Trial registrationTrial registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR) Number: ACTRN12619000676112 , registered 06/05/2019 - retrospectively registered.

Project description:ObjectiveTo determine the feasibility and acceptability of peer-befriending, for people with aphasia.DesignSingle-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending.Participants and settingPeople with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community.InterventionSix 1-hour peer-befriending visits over three months.Main measuresFeasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending.ResultsOf 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated.ConclusionsSUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Dataset Information

One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.

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