Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial
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SUBMITTER: Wolf S
PROVIDER: S-EPMC8556805 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundExercise efficaciously reduces disorder-specific symptoms of psychiatric disorders. The current study aimed to examine the efficacy of a group exercise intervention on global symptom severity and disorder-specific symptoms among a mixed outpatient sample.MethodsGroups of inactive outpatients, waiting for psychotherapy, with depressive disorders, anxiety disorders, insomnia, and attention-deficit/hyperactivity disorders were randomized to a manualized 12-week exercise intervention, combining moderate to vigorous aerobic exercise with techniques for sustainable exercise behaviour change (n = 38, female = 71.1% (n = 27), Mage = 36.66), or a passive control group (n = 36, female = 75.0% (n = 27), Mage = 34.33). Primary outcomes were global symptom severity and disorder-specific symptoms, measured with the Symptom Checklist-90-Revised and Pittsburgh Sleep Quality Index pre- and post-treatment. Secondary outcome was the self-reported amount of exercise (Physical Activity, Exercise, and Sport Questionnaire), measured pre-treatment, intermediate-, and post-treatment. Intention-to-treat analyses were conducted using linear mixed models. Linear regressions were conducted to examine the effect of the change of exercise behaviour on the change of symptoms.ResultsThe intervention significantly improved global symptom severity (d = 0.77, p = .007), depression (d = 0.68, p = .015), anxiety (d = 0.87, p = .002), sleep quality (d = 0.88, p = .001), and increased the amount of exercise (d = 0.82, p < .001), compared to the control group. Post-treatment differences between groups were significant for depression (d = 0.63, p = .031), sleep quality (d = 0.61, p = .035) and the amount of exercise (d = 1.45, p < .001). Across both groups, the reduction of global symptom severity was significantly predicted by an increase of exercise (b = .35, p = .012).ConclusionsThe exercise intervention showed transdiagnostic efficacy among a heterogeneous clinical sample in a realistic outpatient setting and led to sustained exercise behaviour change. Exercise may serve as an efficacious and feasible transdiagnostic treatment option improving the existing treatment gap within outpatient mental health care settings.Trial registrationThe study was registered on ClinicalTrials.gov (ID: NCT03542396 , 25/04/2018).
| S-EPMC8218400 | biostudies-literature
Project description:BackgroundFatigue is a common and troubling symptom for people with multiple sclerosis (MS).AimTo evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)).MethodsThree-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire).ResultsBetween May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue.ConclusionsFACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity.Trial registrationCurrent Controlled Trials ISRCTN76517470.
| S-EPMC3786656 | biostudies-literature
Project description:BackgroundClinical studies indicate that strength-balance training for active fall prevention can prevent fractures in older people. The present modelling study evaluates the cost-effectiveness of fall prevention exercise (FPE) provided to independently living older people compared to no intervention in Germany.MethodWe designed a Markov model to evaluate the cost-effectiveness of a group-based FPE-program provided to independently living people ≥75 years from the perspective of the German statutory health insurance (SHI). Input data was obtained from public databases, clinical trials and official statistics. The incremental cost-effectiveness ratio (ICER) was presented as costs per avoided hip fracture. Additionally, we performed deterministic and probabilistic sensitivity analyses and, estimated monetary consequences for the SHI in a budget impact analysis (BIA).ResultsFor women, the costs per hip fracture avoided amounted to €52,864 (men: €169,805). Results of deterministic and probabilistic sensitivity analyses confirmed the robustness of the results. According to the BIA, for the reimbursement of FPE additional costs of €3.0 million (women) and €7.8 million (men) are expected for the SHI.ConclusionsGroup-based FPE appears to be no cost-effective option to prevent fall-related hip fractures in independently living elderly. To allow a more comprehensive statement on the cost effectiveness of FPE fracture types other than hip should be increasingly evaluated in clinical trials.
| S-EPMC8314607 | biostudies-literature
Project description:BackgroundThe high prevalence of women that do not reach the recommended level of physical activity is worrisome. A sedentary lifestyle has negative consequences on health status and increases health care costs. The main objective of this project is to assess the cost-effectiveness of a primary care-based exercise intervention in perimenopausal women.Methods/designThe present study is a Randomized Controlled Trial. A total of 150 eligible women will be recruited and randomly assigned to either a 16-week exercise intervention (3 sessions/week), or to usual care (control) group. The primary outcome measure is the incremental cost-effectiveness ratio. The secondary outcome measures are: i) socio-demographic and clinical information; ii) body composition; iii) dietary patterns; iv) glycaemic and lipid profile; v) physical fitness; vi) physical activity and sedentary behaviour; vii) sleep quality; viii) quality of life, mental health and positive health; ix) menopause symptoms. All outcomes will be assessed at baseline and post intervention. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct a cost effectiveness analysis from a health system perspective.DiscussionThe intervention designed is feasible and if it proves to be clinically and cost effective, it can be easily transferred to other similar contexts. Consequently, the findings of this project might help the Health Systems to identify strategies for primary prevention and health promotion as well as to reduce health care requirements and costs.Trial registrationClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015.
| S-EPMC4470091 | biostudies-literature
Project description:To examine the cost and cost-effectiveness of implementing Students for Nutrition and eXercise (SNaX), a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education.Five intervention and 5 control middle schools (mean enrollment, 1520 students) from the Los Angeles Unified School District participated in a randomized controlled trial of SNaX. Acquisition costs for materials and time and wage data for employees involved in implementing the program were used to estimate fixed and variable costs. Cost-effectiveness was determined using the ratio of variable costs to program efficacy outcomes.The costs of implementing the program over 5 weeks were $5433.26 per school in fixed costs and $2.11 per student in variable costs, equaling a total cost of $8637.17 per school, or $0.23 per student per day. This investment yielded significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks. The cost-effectiveness of the program, per student over 5 weeks, was $1.20 per additional fruit served during meals, $8.43 per additional full-priced lunch served, $2.11 per additional reduced-price/free lunch served, and $1.69 per reduction in snacks sold.SNaX demonstrated the feasibility and cost-effectiveness of a middle school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. Its cost is modest and unlikely to be a significant barrier to adoption for many schools considering its implementation.
| S-EPMC4808504 | biostudies-literature
Project description:To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD).Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC).After 1 year, NC+EUC resulted in a net decrease of 3.3 (confidence interval: 1.7 to 4.8) percentage points in 10-year CVD event risk (number needed to treat = 30). These risk reductions came with average net study-year savings of $1138 in societal costs and $1187 in employer costs. There was no change in quality-adjusted life years across the study year.A naturopathic approach to CVD primary prevention significantly reduced CVD risk over usual care plus biometric screening and reduced costs to society and employers in this multi-worksite-based study. Trial Registration clinicaltrials.gov Identifier: NCT00718796.
| S-EPMC3921268 | biostudies-literature
Project description:OBJECTIVES:To estimate the cost-effectiveness and population impact of the national implementation of the Study of Technology to Accelerate Research (STAR) intervention for childhood obesity. METHODS:In the STAR cluster-randomized trial, 6- to 12-year-old children with obesity seen at pediatric practices with electronic health record (EHR)-based decision support for primary care providers and self-guided behavior-change support for parents had significantly smaller increases in BMI than children who received usual care. We used a microsimulation model of a national implementation of STAR from 2015 to 2025 among all pediatric primary care providers in the United States with fully functional EHRs to estimate cost, impact on obesity prevalence, and cost-effectiveness. RESULTS:The expected population reach of a 10-year national implementation is ?2 million children, with intervention costs of $119 per child and $237 per BMI unit reduced. At 10 years, assuming maintenance of effect, the intervention is expected to avert 43?000 cases and 226?000 life-years with obesity at a net cost of $4085 per case and $774 per life-year with obesity averted. Limiting implementation to large practices and using higher estimates of EHR adoption improved both cost-effectiveness and reach, whereas decreasing the maintenance of the intervention's effect worsened the former. CONCLUSIONS:A childhood obesity intervention with electronic decision support for clinicians and self-guided behavior-change support for parents may be more cost-effective than previous clinical interventions. Effective and efficient interventions that target children with obesity are necessary and could work in synergy with population-level prevention strategies to accelerate progress in reducing obesity prevalence.
| S-EPMC5654390 | biostudies-literature
Project description:BackgroundAnxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care.Methods/designThe trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups. a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation.Statistical analysisIntention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention.DiscussionThis rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy.Trial registrationClinicalTrials.gov: NCT02811458 .
| S-EPMC6169021 | biostudies-literature
Project description:BACKGROUND:Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. METHODS/DESIGN:Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. DISCUSSION:This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. TRIAL REGISTRATION ISRCTN:ISRCTN93634563.
| S-EPMC4123500 | biostudies-literature
Project description:The prevalence of HIV among U.S. inmates is much greater than in the general population, creating public health concerns and cost issues for the criminal justice system. The HIV Services and Treatment Implementation in Corrections protocol of the NIDA funded Criminal Justice Drug Abuse Treatment Studies cooperative tested the efficacy of an organizational process improvement strategy on improving HIV services in correctional facilities. For this paper, we analyzed efficacy of this strategy on improving inmate awareness and perceptions of HIV services. The study used a multi-site (n=28) clustered randomized trial approach. Facilities randomized to the experimental condition used a coach-driven local change team approach to improve HIV services at their facility. Facilities in the control condition were given a directive to improve HIV services on their own. Surveys about awareness and perceptions of HIV services were administered anonymously to inmates who were incarcerated in study facilities at baseline (n=1253) and follow-up (n=1048). A series of one-way ANOVAs were run to test whether there were differences between inmates in the experimental and control facilities at baseline and follow-up. Differences were observed at baseline, with the experimental group having significantly lower scores than the control group on key variables. But, at post-test, following the intervention, these differences were no longer significant. Taken in context of the findings from the main study, these results suggest that the change team approach to improving HIV services in correctional facilities is efficacious for improving inmates' awareness and perceptions of HIV services.
| S-EPMC4507816 | biostudies-literature