Randomised controlled trial of a psychotherapeutic intervention to improve quality of life and other outcomes in people who repeatedly self-harm: FReSH START study protocol
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SUBMITTER: Farley K
PROVIDER: S-EPMC11346196 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:To develop and pilot a theory and evidence-based intervention to improve quality of life (QoL) in people with colorectal cancer.A complex intervention development study.North East Scotland and Glasgow.Semistructured interviews with people with colorectal cancer (n=28), cancer specialists (n=16) and primary care health professionals (n=14) and pilot testing with patients (n=12).A single, 1 h nurse home visit 6-12 weeks after diagnosis, and telephone follow-up 1 week later (with a view to ongoing follow-up in future).Qualitative assessment of intervention feasibility and acceptability.Modifiable predictors of QoL identified previously were symptoms (fatigue, pain, diarrhoea, shortness of breath, insomnia, anorexia/cachexia, poor psychological well-being, sexual problems) and impaired activities. To modify these symptoms and activities, an intervention based on Control Theory was developed to help participants identify personally important symptoms and activities; set appropriate goals; use action planning to progress towards goals; self-monitor progress and identify (and tackle) barriers limiting progress. Interview responses were generally favourable and included recommendations about timing and style of delivery that were incorporated into the intervention. The pilot study demonstrated the feasibility of intervention delivery.Through multidisciplinary collaboration, a theory-based, acceptable and feasible intervention to improve QoL in colorectal cancer patients was developed, and can now be evaluated.
| S-EPMC3641512 | biostudies-other
Project description:ObjectiveTreatment interruptions are a barrier to successful antiretroviral therapy (ART). 'Fresh start messages', which leverage significant days on the calendar (e.g., new year, public holiday) in order to prompt action, have the potential to encourage people with HIV (PWH) to return to care. We evaluated a 'fresh start' intervention (text messages) to increase return to care in PWH who had missed their last appointment.DesignA three arm 1 : 1:1 individual randomised controlled trial.MethodsWe randomized adults in Capricorn District who had missed ART appointments by >28 days to: no text message; unframed messages (fresh start not mentioned); or framed messages (fresh start mentioned). Randomization was stratified by treatment interruption duration and across two holidays (Youth Day, Mandela Day). The primary outcome was an ART-related clinic visit at ≤45 days of the first message.Results9143 participants were randomised. For Youth Day, 1474 and 1468 were sent unframed and framed messages respectively, with 13.4% sent these messages having an ART visit vs. 11.9% not sent a message [adjusted odds ratio (aOR) 1.2; 95% confidence interval (CI): 1.0-1.4, P -value = 0.075]. For Mandela Day, 1336 and 1334 were sent unframed and framed messages respectively, with 6.7% sent these messages having an ART-related clinic visit vs. 5.4% not sent a message (aOR 1.2; 95% CI: 1.0-1.6; P -value = 0.100).ConclusionsLow-cost text messages sent around a 'fresh start' date may increase the likelihood that patients who miss appointments return to care. This study suggests the potential of text messaging for motivating return to care.
| S-EPMC11239091 | biostudies-literature
Project description:BackgroundHearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions.MethodsThis is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness.DiscussionThis is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment.Trial registrationISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.
| S-EPMC6347775 | biostudies-literature
Project description:Therapeutic interventions are an important adjunct to self-help strategies for people who self-harm. There is little guidance for those offering therapy on the effective components of interventions for people who self-harm. This was a systematic review aiming to identify the factors that contribute to positive experiences of therapy as described by people who have reduced or stopped self-harm. The review followed PRISMA guidelines to locate and synthesize peer-reviewed qualitative studies describing experiences of therapy among people who had reduced or stopped self-harm. Study selection, data extraction, and quality assessment were peer reviewed and conducted for at least two researchers independently. Relevant first-hand quotations were extracted from eligible studies and synthesized using a thematic analysis in collaboration with experts with personal and professional experience of self-harm. Twenty-three studies met eligibility criteria. Themes identified in the reported accounts were arranged under two meta-themes. 'Positive aspects of seeing a professional' identified aspects of professional care that were common to all encounters: the value of sharing, space to talk and reflect, and the boundaries inherent in contact with a professional. 'Positive attributes of individual professionals' depended upon individual characteristics: the ability to build reciprocal trust by being non-judgemental, showing genuine empathic concern, and being confident to talk about and respond directly to self-harm. Our review indicates that therapeutic alliance is perceived as key to effective professional help for self-harm, irrespective of underlying principles of therapy. All forms of therapy should be timely and reliable and centred around the needs of the individual and their experience of self-harm.
| S-EPMC9306637 | biostudies-literature
Project description:IntroductionGermany and the European Union have experienced successive waves of refugees since 2014, resulting in over 1.6 million arrivals, including families with young children. These vulnerable populations often face xenophobia, discrimination, substandard living conditions and limited healthcare access, contributing to a high prevalence of mental health problems (MHP). Our primary goal is to proactively address MHP in refugee parents and prevent its potential impact on their children through effective early interventions. Using a low-threshold, primary care-based approach, we aim to enhance parenting skills and address parental psychopathology, creating a supportive environment for parents and children.Methods and analysisIn this randomised controlled trial, 188 refugee parents of 6-year-old children or younger who meet the clinical cut-off on the MHP scale will participate. They are randomly assigned to either the experimental psychotherapeutic intervention, delivered by general practitioners (10-week Improve intervention), or treatment as usual, in a ratio of 1:1. The randomisation will be masked only for outcome assessors. Improve includes face-to-face sessions with general practitioners, an interactive online parenting programme (Triple P Online) and regular protocol-based telephone calls by psychologists. Primary outcomes will assess the intervention's effects on parental and child MHP and parenting skills, with secondary outcomes including psychosocial and physical health indicators. Outcomes will be assessed at pre, post and at 3-month and 6-month follow-ups. The study is scheduled to run from February 2019 to July 2025.Ethics and disseminationThe project Improve-MH (application number 602) was approved by the local ethics committee of Ruhr-University of Bochum and is being conducted in accordance with the Declaration of Helsinki. The study is also conducted in full accordance with the German Data Protection Act, and the Good Clinical Practice guideline (GCP) and is sensitive to specific ethical considerations. Results will be disseminated at scientific conferences, published in peer-reviewed journals and provided to consumers of healthcare.Trial registration numberThe trial was prospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00019072) on 16 March 2020.
| S-EPMC11423745 | biostudies-literature
Project description:Assessing suicidality is common in mental health practice and is fundamental to suicide research. Although necessary, there is significant concern that such assessments have unintended harmful consequences. Using a longitudinal randomized control design, the authors evaluated whether repeated and frequent assessments of suicide-related thoughts and behaviors negatively affected individuals, including those at-risk for suicide-related outcomes. Adults (N = 282), including many diagnosed with borderline personality disorder (BPD), were recruited through psychiatric outpatient clinics and from the community at large, and were randomly assigned to assessment groups. A control assessment group responded to questions regarding negative psychological experiences several times each day during a 2-week main observation phase. During the same observation period, an intensive suicide assessment group responded to the same questions, along with questions regarding suicidal behavior and ideation. Negative psychological outcomes were measured during the main observation phase (for BPD symptoms unrelated to suicide and for BPD-relevant emotions) and/or at the end of each week during the main observation phase and monthly for 6 months thereafter (for all outcomes, including suicidal ideation and behavior). Results revealed little evidence that intensive suicide assessment triggered negative outcomes, including suicidal ideation or behavior, even among people with BPD. A handful of effects did reach or approach significance, though these were temporary and nonrobust. However, given the seriousness of some outcomes, the authors recommend that researchers or clinicians who implement experience sampling methods including suicide-related items carefully consider the benefits of asking about suicide and to inform participants about possible risks.
| S-EPMC4615260 | biostudies-literature
Project description:BackgroundChildren and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wellbeing as well as poorer quality of life than their peers with 'healthy' parents. The needs of COPMI are likely to be significant; however, their prevalence is unknown, although estimates suggest over 60% of adults with a serious mental illness have children. Many receive little or no support and remain 'hidden', stigmatised or do not regard themselves as 'in need'. Recent UK policies have identified supporting COPMI as a key priority, but this alone is insufficient and health-related quality of life has been neglected as an outcome.Methods/designAn age-appropriate standardised intervention for COPMI, called Young SMILES, was developed in collaboration with service users, National Health Service (NHS) and non-NHS stakeholders in our previous work. This protocol describes a randomised feasibility trial comparing Young SMILES with usual care, involving 60 families that will be identified through third sector organisations and NHS services, and recruited and randomised on a 1:1 basis to receive Young SMILES or usual care. Outcomes of the feasibility trial are rates of recruitment, follow-up and withdrawals, intervention uptake, and engagement. The optimal child-reported outcomes will also be determined alongside the assessment of resource use. A qualitative evaluation conducted at 3-months will explore the experiences and views of children and young people as well as parents accessing the intervention and the facilitators delivering the intervention.DiscussionThis paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES.Trial registrationISRCTN36865046 , registered 18 December 2015.
| S-EPMC6186077 | biostudies-literature
Project description:BackgroundThe primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support.Methods/designThis international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored.DiscussionThis definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action.Trial registrationClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.
| S-EPMC6044003 | biostudies-literature
Project description:BACKGROUND:People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the 'Cancer Home-Life Intervention'. AIM:To evaluate the efficacy of the 'Cancer Home Life-Intervention' compared with usual care with regard to patients' performance of, and participation in, everyday activities, and their health-related quality of life. DESIGN AND INTERVENTION:A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The 'Cancer Home-Life Intervention' is a brief, tailored, occupational therapy-based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. SETTING/PARTICIPANTS:Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. RESULTS:A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: -0.04 logits (95% confidence interval: -0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. CONCLUSION:In most cases, the 'Cancer Home-Life Intervention' was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants' everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.
| S-EPMC5881790 | biostudies-literature
Project description:BackgroundOverweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Methods/designStudy participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.DiscussionThe Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.Trial registrationclinicaltrials.gov NCT02176915 . Registered 25 June 2014.
| S-EPMC5016872 | biostudies-literature