Barriers to recruitment, retention and intervention delivery in a randomized trial among patients with firearm injuries

Abstract Background We discuss barriers to recruitment, retention, and intervention delivery in a randomized controlled trial (RCT) of patients presenting with firearm injuries to a Level 1 trauma center. The intervention was adapted from the Critical Time Intervention and included a six-month period of support in the community after hospital discharge to address recovery goals. This study was one of the first RCTs of a hospital- and community-based intervention provided solely among patients with firearm injuries. Main text Barriers to recruitment included limited staffing, coupled with wide variability in length of stay and admission times, which made it difficult to predict the best time to recruit. At the same time, more acutely affected patients needed more time to stabilize in order to determine whether eligibility criteria were met. Barriers to retention included insufficient patient resources for stable housing, communication and transportation, as well as limited time for patients to meet with study staff to respond to follow-up surveys. These barriers similarly affected intervention delivery as patients who were recruited, but had fewer resources to help with recovery, had lower intervention engagement. These barriers fall within the broader context of system avoidance (e.g., avoiding institutions that keep formal records). Since the patient sample was racially diverse with the majority of patients having prior criminal justice system involvement, this may have precluded active participation from some patients, especially those from communities that have been subject to long and sustained history of trauma and racism. We discuss approaches to overcoming these barriers and the importance of such efforts to further implement and evaluate hospital-based violence intervention programs in the future. Conclusion Developing strategies to overcome barriers to data collection and ongoing participant contact are essential to gathering robust information to understand how well violence prevention programs work and providing the best care possible for people recovering from injuries. Trial registration ClinicalTrials.govNCT02630225. Registered 12/15/2015.

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Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk

BMJ Open ◽

10.1136/bmjopen-2020-037075 ◽

2020 ◽

Vol 10 (9) ◽

pp. e037075 ◽

Cited By ~ 1

Author(s):

Philip AJ Crosbie ◽

Rhian Gabe ◽

Irene Simmonds ◽

Martyn Kennedy ◽

Suzanne Rogerson ◽

...

Keyword(s):

Lung Cancer ◽

Usual Care ◽

Low Dose ◽

Task Force ◽

Controlled Trial ◽

Advisory Group ◽

Eligibility Criteria ◽

Link Type ◽

Lung Screening ◽

Screening Trial

IntroductionLung cancer is the world’s leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.Methods and analysisUsing a single-consent Zelen’s design, ever-smokers aged 55–80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.Ethics and disseminationThe study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.Trial registration numbersISRCTN42704678 and NCT03750110.

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Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

BMC Geriatrics ◽

10.1186/s12877-019-1379-5 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Sarah E. Goldberg ◽

◽

Veronika van der Wardt ◽

Andy Brand ◽

Clare Burgon ◽

...

Keyword(s):

Adverse Events ◽

Falls Prevention ◽

Feasibility Trial ◽

Moderate Intensity ◽

Eligibility Criteria ◽

Intervention Delivery ◽

Link Type ◽

Early Dementia ◽

Randomised Controlled

Abstract Background We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. Methods We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. Results Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. Conclusion We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. Trial registration ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

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Fidelity Assessment of a Social Work–Led Intervention Among Patients With Firearm Injuries

Research on Social Work Practice ◽

10.1177/1049731520912002 ◽

2020 ◽

Vol 30 (6) ◽

pp. 678-687

Author(s):

Vivian H. Lyons ◽

Lina R. Benson ◽

Elizabeth Griffin ◽

Anthony S. Floyd ◽

Sharon W. Kiche ◽

...

Keyword(s):

Social Work ◽

Controlled Trial ◽

Implementation Fidelity ◽

Assessment Process ◽

Ongoing Trial ◽

Intervention Delivery ◽

Firearm Injury ◽

Firearm Injuries ◽

Fidelity Assessment ◽

Study Intervention

Purpose: To support future development and refinement of social work–led intervention programs among patients with firearm injuries and to demonstrate how a fidelity assessment can be used to adjust and refine intervention delivery in an ongoing trial. Method: We conducted a fidelity assessment of a randomized controlled trial of a social work–led intervention among patients with a firearm injury. Results: We found that our study intervention was well implemented, meeting 70% of the fidelity assessment score items, however, noted lower fidelity with client-based items. Discussion: As a result of fidelity assessment findings, we refined intervention delivery to improve implementation fidelity including beginning to review cases of all patients each month rather than focusing on patients in crisis. Our fidelity assessment process and findings offer insight into the challenges of implementing an intervention among patients with firearm injuries and highlight the value of monitoring intervention fidelity during an ongoing trial.

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Cervicovestibular rehabilitation in adult with mild traumatic brain injury: a randomised controlled trial protocol

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-019-0139-3 ◽

2019 ◽

Vol 11 (1) ◽

Cited By ~ 1

Author(s):

Pierre Langevin ◽

Philippe Fait ◽

Pierre Frémont ◽

Jean-Sébastien Roy

Keyword(s):

Traumatic Brain Injury ◽

Cervical Spine ◽

Brain Injury ◽

Neck Pain ◽

Mild Traumatic Brain Injury ◽

Controlled Trial ◽

Rehabilitation Program ◽

Conventional Approach ◽

Persistent Symptoms ◽

Link Type

Abstract Background Mild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated. Objective To compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week). Methods In this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used. Discussion Controlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations. Trial registration ClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

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Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00822-2 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Audrey Rankin ◽

◽

Cathal A. Cadogan ◽

Heather E. Barry ◽

Evie Gardner ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Older People ◽

Usual Care ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Online Video ◽

Link Type ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

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Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial

Trials ◽

10.1186/s13063-021-05317-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Terry Guirado ◽

Lore Metz ◽

Bruno Pereira ◽

Audrey Bergouignan ◽

David Thivel ◽

...

Keyword(s):

Physical Activity ◽

Psychological Health ◽

Controlled Trial ◽

Office Workers ◽

Health Study ◽

Full Time ◽

Eating Behaviours ◽

Potential Health ◽

Link Type ◽

Working Day

Abstract Background Sedentary behaviour (SB) and low levels of physical activity (PA) are predictors of morbidity and mortality. Tertiary employees spend a considerable amount of their daily time seated and new efficient strategies to both reduce sedentary time and increase physical activity are needed. In that context, the REMOVE study aims at evaluating the health effects of a 24-week cycling desk intervention among office workers. Methods A prospective, open-label, multicentre, two-arm parallel, randomized controlled trial (RCT) will be conducted in office-sitting desk workers. Office workers (N = 80) who have 0.8 full time equivalent hours (FTE) and 75% of this time in a sitting position will be recruited from tertiary worksites in Clermont-Ferrand, France. Subjects will be randomly assigned to one of the two following interventions: (i) PPM6: performance of two 30 min of cycling desk (using portable pedal exercise machine—PPM) per working day for 6 months or (ii) CTL_PPM3: 3 months with no intervention (control) followed by 3 months during which workers will be asked to complete two 30 min of PPM per working day. At baseline (T0), at 3 months (T1) and at 6 months (T2) after the start of the interventions, primary outcomes; 7-day PA and SB (3D-accelerometers), secondary outcomes; body composition (bioelectrical impedance), physical fitness (aerobic fitness, upper and lower limb strength), metabolic outcomes (fasting blood samples), self-perceived stress, anxiety, quality of life at work and job strain (questionnaires), tertiary outcomes; resting metabolic rate and cycling energy expenditure (indirect calorimetry) and eating behaviours (questionnaires) will be measured. An ergonomic approach based on observations and individual interviews will be used to identify parameters that could determine adherence. Discussion The REMOVE study will be the first RCT to assess the effects of cycling workstations on objectively measured PA and SB during working and non-working hours and on key physiological and psychological health outcomes. This study will provide important information regarding the implementation of such cycling workstations in office workers and on the associated potential health benefits. Trial registration ClinicalTrials.govNCT04153214. Registered on November 2019, version 1

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Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04261-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Seung Mi Yeo ◽

Ji Young Lim ◽

Jong Geol Do ◽

Jae-Young Lim ◽

Jong In Lee ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Physical Therapy ◽

Augmented Reality ◽

Controlled Trial ◽

Adhesive Capsulitis ◽

Performance Measure ◽

Home Exercise ◽

Randomized Controlled ◽

Link Type ◽

Home Based

Abstract Background As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. Methods This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. Discussion This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of “telerehabilitation” using hardware (IoT) and software (monitoring platform) technologies to develop “digital therapeutics” for the future. Trial registration This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130.

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National survey of feasibility of NIV trials for management of children with bronchiolitis

BMJ Paediatrics Open ◽

10.1136/bmjpo-2020-000780 ◽

2020 ◽

Vol 4 (1) ◽

pp. e000780

Author(s):

Anna Rosala-Hallas ◽

Ashley P Jones ◽

Emma Bedson ◽

Vanessa Compton ◽

Ricardo M Fernandes ◽

...

Keyword(s):

National Survey ◽

Controlled Trial ◽

Management Strategies ◽

Eligibility Criteria ◽

Training Requirements ◽

Non Invasive Ventilation ◽

Respiratory Management ◽

Randomised Controlled ◽

The Uk ◽

Future Work

BackgroundBronchiolitis is a major cause of admission to hospital in children. Non-invasive ventilation (NIV) support with continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) oxygen is routinely used for infants in the UK with bronchiolitis.ObjectiveTo establish UK paediatric practice regarding management of bronchiolitis, and to explore issues pertinent to the design of a potential future randomised controlled trial of NIV.DesignScreening logs were completed in hospitals in England capturing information on paediatric bronchiolitis admissions. An online national survey of clinical practice was disseminated to healthcare professionals (HCPs) across the UK to ascertain current management strategies.ResultsScreening logs captured data on 393 infants from 8 hospitals. Reasons for admission were most commonly respiratory distress and/or poor fluid intake. Oxygen was administered for 54% of admissions. Respiratory (CPAP and HFNC) and non-respiratory support administered varied considerably. The national survey was completed by 111 HCPs from 76 hospitals. Data were obtained on criteria used to commence and wean NIV, responsibilities for altering NIV settings, minimum training requirements for staff managing a child on NIV, and numbers of trained staff. Most centres were interested in and capable of running a trial of NIV, even out of normal office hours.ConclusionsRespiratory and non-respiratory management of bronchiolitis in UK centres varies widely. A trial of HFNC oxygen therapy in this group of patients is feasible and HCPs would be willing to randomise patients into such a trial. Future work should focus on defining trial eligibility criteria.

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The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy—a randomized controlled trial

Trials ◽

10.1186/s13063-021-05191-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Anna Guerrini Usubini ◽

Roberto Cattivelli ◽

Emanuele Maria Giusti ◽

Francesco Vailati Riboni ◽

Giorgia Varallo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Acceptance And Commitment Therapy ◽

Mechanism Of Action ◽

Healthy Lifestyle ◽

Controlled Trial ◽

Psychological Flexibility ◽

Randomized Controlled ◽

Link Type ◽

Commitment Therapy ◽

Acceptance And Commitment

Abstract Background As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. Methods A randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m2), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6 months (time 3) and 9 months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of the intervention, mixed between-within 3 (conditions) × 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups. Discussion This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle. Trial registration ClinicalTrials.govNCT04474509. Registered on July 4, 2020

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