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STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol.

ABSTRACT: INTRODUCTION:Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment. METHODS AND ANALYSIS:480 patients (aged 18-65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2:1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020. ETHICS AND DISSEMINATION:The study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universität Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public. TRIAL REGISTRATION NUMBER:ISRCTN28972230.

SUBMITTER: Heissel A

PROVIDER: S-EPMC7200038 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol.

Heissel Andreas A Pietrek Anou A Schwefel Melanie M Abula Kahar K Wilbertz Gregor G Heinzel Stephan S Rapp Michael M

BMJ open 20200414 4

<h4>Introduction</h4>Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment.<h4>Methods and analysis</h4>480 patients (aged 18-65) with an International Classi ...[more]

PMID: 32295779

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Project description:INTRODUCTION:Controlled trials support the efficacy of exercise as a treatment modality for chronic conditions, yet effectiveness of real-world Exercise Physiology services is yet to be determined. This study will investigate the efficacy and cost-effectiveness of services provided by Accredited Exercise Physiologists (AEPs) for clients with type 2 diabetes (T2D) in clinical practice. METHODS AND ANALYSIS:A non-randomised, opportunistic control, longitudinal design trial will be conducted at ten Exercise Physiology Clinics. Participants will be individuals with T2D attending one of the Exercise Physiology Clinics for routine AEP services (exercise prescription and counselling) (intervention) or individuals with T2D not receiving AEP services (usual care) (control). The experimental period will be 6 months with measurements performed at baseline and at 6 months. Primary outcome measures will be glycosylated haemoglobin (HbA1c), resting brachial blood pressure (BP), body mass index, waist circumference, 6 min walk test, grip strength, 30 s sit to stand, Medical Outcomes Short-Form 36-Item Health Survey and Active Australia Questionnaire. Secondary outcomes will be medication usage, out-of-pocket expenses, incidental, billable and non-billable health professional encounters and work missed through ill health. Healthcare utilisation will be measured for 12 months prior to, during and 12 months after trial participation using linked data from Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data. ETHICS AND DISSEMINATION:The study is a multicentre trial comprising: University of Tasmania, University of New South Wales Lifestyle Clinic, University of Canberra, Baker Heart and Diabetes Institute (covered under the ethics approval of University of Tasmania Health and Medical Ethics Committee H0015266), Deakin University (Approval number: 2016-187), Australian Catholic University (2016-304R), Queensland University of Technology (1600000049), University of South Australia (0000035306), University of Western Australia (RA/4/1/8282) and Canberra Hospital (ETH.8.17.170). The findings of this clinical trial will be communicated via peer-reviewed journal articles, conference presentations, social media and broadcast media. TRIAL REGISTRATION NUMBER:ACTRN12616000264482.

Project description:RATIONALE:More thoroughly understanding the association between elevated depressive symptoms and effectiveness level of contraceptive method selected at a reproductive health visit could help women prevent unintended pregnancy. OBJECTIVE:This study examined how the association between both current and past depressive symptoms and effectiveness level of contraceptive method selected at a clinic visit varies by type of reproductive health visit. METHODS:Current and past depressive symptoms and contraceptive method selected were assessed among 1215 women aged 18-25 years seeking general reproductive health or abortion services at 40 community clinics throughout the United States. Using standard categories of effectiveness based on pregnancy rates during typical use, women's contraceptive method selected was coded as a low (e.g., no method, withdrawal, condoms), moderately (pill, patch, ring, or shot), or highly effective method (IUD, sterilization, implant). Depression status was divided into four categories: 1) no elevated depressive symptoms ever, 2) current elevated depressive symptoms only, 3) past elevated depressive symptoms only, and 4) past and current elevated depressive symptoms. Visit type, general reproductive health versus abortion care, was a moderator. The interaction effect between depressive symptoms and visit type on contraceptive method effectiveness level chosen was estimated with multinomial logistic regression analyses. RESULTS:In general reproductive health visits, having both elevated current and past depressive symptoms increased women's likelihood of choosing low versus moderately effective methods (RRR?=?5.63, 95% CI?=?2.31 to 13.71, p?<?.0005). In contrast, among abortion patients, only current elevated depressive symptoms were associated with choosing high versus moderate effectiveness methods (RRR?=?1.74, 95% CI?=?1.06 to 2.86, p?=?.029). CONCLUSION:Results suggest that considering both women's current and past elevated depressive symptoms and the type of reproductive health visit may assist providers in helping women prevent unintended pregnancy.

Project description:BACKGROUND:Four percent of the world's population suffers from depression, which is a major public health issue. Medical students are at risk, as their depressive symptoms (DS) prevalence is reported to be approximately 27% worldwide. Since few data on Italian medical students exist, this study aimed to estimate their DS prevalence and assess risk and protective factors. METHODS:The PRIMES was a multicentre cross-sectional study performed in 12 Italian medical schools. Questionnaires were self-reported and included 30 sociodemographic items and the Beck Depression Inventory-II (BDI-II). The primary outcome was the presence of DS (BDI-II score?14). The main analyses were chi-squared tests and multivariable logistic regressions with a p-value<0.05 considered significant. RESULTS:The number of collected questionnaires was 2,513 (117 BDI-II incomplete). Females accounted for 61.3% of the respondents, and the median age was 22 years (IQR = 4). The prevalence of DS was 29.5%. Specifically, 14.0% had mild depression, 11.1% had moderate depression, and 4.5% had severe depression. The main risk factors for DS were age, being female, bisexual/asexual orientation, living with partner/housemates, poor economic status (worsened by living far from home), less than 90 min of weekly exercise, relatives with psychiatric disorders, personal chronic disease, judging medical school choice negatively, unsatisfying friendships with classmates, competitive and hostile climate among classmates, thinking that medical school hinders specific activities and being worried about not measuring up to the profession. Protective factors included family cohesion, hobbies, intellectual curiosity as a career motivation and no worries about the future. CONCLUSION:Italian medical students are at high risk of reporting DS, similar to the global population of medical students'. Medical schools must make efforts to implement preventive and treatment interventions by offering counselling and working on modifiable factors, such as lifestyle and learning climate.

Project description:BackgroundSome older people who find standard exercise programmes too strenuous may be encouraged to exercise while remaining seated - chair based exercises (CBE). We previously developed a consensus CBE programme (CCBE) following a modified Delphi process. We firstly needed to test the feasibility and acceptability of this treatment approach and explore how best to evaluate it before undertaking a definitive trial.MethodsA feasibility study with a cluster randomised controlled trial component was undertaken to 1. Examine the acceptability, feasibility and tolerability of the intervention and 2. Assess the feasibility of running a trial across 12 community settings (4 day centres, 4 care homes, 4 community groups). Centres were randomised to either CCBE, group reminiscence or usual care. Outcomes were collected to assess the feasibility of the trial parameters: level of recruitment interest and eligibility, randomisation, adverse events, retention, completion of health outcomes, missing data and delivery of the CCBE. Semi- structured interviews were conducted with participants and care staff following the intervention to explore acceptability.Results48% (89 out of 184 contacted) of eligible centres were interested in participating with 12 recruited purposively. 73% (94) of the 128 older people screened consented to take part with 83 older people then randomised following mobility testing. Recruitment required greater staffing levels and resources due to 49% of participants requiring a consultee declaration. There was a high dropout rate (40%) primarily due to participants no longer attending the centres. The CCBE intervention was delivered once a week in day centres and community groups and twice a week in care homes. Older people and care staff found the CCBE intervention largely acceptable.ConclusionThere was a good level of interest from centres and older people and the CCBE intervention was largely welcomed. The trial design and governance procedures would need to be revised to maximise recruitment and retention. If the motivation for a future trial is physical health then this study has identified that further work to develop the CCBE delivery model is warranted to ensure it can be delivered at a frequency to elicit physiological change. If the motivation for a future trial is psychological outcomes then this study has identified that the current delivery model is feasible.Trial registrationISRCTN27271501 . Date registered: 30/01/2018.

Project description:Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention.In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; ? blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299.72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a ? blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months.The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records.Patient Safety Research Portfolio, Department of Health, England.

Project description:BackgroundAround 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation.MethodsAn external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed.ResultsEight out of twenty teams were recruited and randomised. Of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months.DiscussionWhile valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions.Trial registrationISRCTN34701576 . Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

Project description:BackgroundThere is limited access to eye health services in many low-income and middle-income populations. We aimed to assess the effectiveness in increasing service utilisation of the Peek Community Eye Health (Peek CEH) system, a smartphone-based referral system comprising decision support algorithms (Peek Community Screening app), SMS reminders, and real-time reporting.MethodsIn this cluster-randomised controlled trial of eye health in Kenya, community unit clusters were defined as one health centre and its catchment population. Clusters were randomly allocated (1:1) to receive Peek CEH and referral (intervention group) or standard care via periodic health centre-based outreach clinics and onward referral (control group). Individuals in the intervention group were assessed at home by screeners and those referred were asked to present for triage assessment in a central location. They received regular SMS reminders. In both groups, community sensitisation was done followed by a triage clinic at the cluster health centre 4 weeks after sensitisation. During triage, individuals in both groups were assessed and treated and, if necessary, referred to a specific hospital. Individuals in the intervention group received further SMS reminders. The primary outcome was the mean attendance rate (the number of people per 10 000 population) at triage of those with confirmed eye conditions, as assessed at 4 weeks after sensitisation in the intention-to-treat population. We estimated the intervention effect using a Student's t-test on cluster-level rates. This trial is registered with Pan African Clinical Trial Registry, number 201807329096632.FindingsBetween Nov 26, 2018, and June 7, 2019, of the 85 community units in Trans Nzoia County, Kenya, 49 were excluded. We randomly allocated 18 community units each to the intervention group (68 348 individuals) and the control group (60 243 individuals). 9387 individuals from the intervention group and 3070 from the control group attended triage assessment. The mean attendance rate at triage by individuals with eye problems was 1429 (92% CI 1228-1629) in the intervention group and 522 (418-625) in the control group (rate difference 906 per 10 000 [95% CI 689-1124; p<0·0001]).InterpretationThe Peek CEH system increased primary care attendance by people with eye problems compared with standard approaches, indicating the potential of this mobile health package to increase service uptake and guide appropriate task sharing.FundingThe Queen Elizabeth Diamond Jubilee Trust and Wellcome Trust.

Dataset Information

STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol.

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STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol.

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