Articles

Facilitating treatment engagement for early psychosis through peer-delivered decision support: intervention development and protocol for pilot evaluation

Emerging adults with early psychosis demonstrate high rates of service disengagement from critical early intervention services. Decision support interventions and peer support have both been shown to enhance s...

Authors: Elizabeth C. Thomas, John Suarez, Alicia Lucksted, Laura A. Siminoff, Irene Hurford, Lisa B. Dixon, Maria O’Connell, David L. Penn and Mark S. Salzer

Adaptability and Resilience in Aging Adults (ARIAA): protocol for a pilot and feasibility study in chronic low back pain

Chronic low back pain (cLBP) is the leading cause of disability among older adults and one of the top reasons for seeking healthcare, resulting in significant decrements in physical functioning. Because older ...

Authors: Paige E. Lysne, Shreela Palit, Calia A. Morais, Lucas C. DeMonte, Maria Lakdawala, Kimberly T. Sibille and Emily J. Bartley

Strategies for Empowering activities in Everyday life (SEE 1.0): study protocol for a feasibility study of an Internet-based occupational therapy intervention for people with stroke

Rehabilitation after stroke seldom focuses on needs related to an active everyday life and the process of change that people must undergo to adapt to an altered capacity and life situation. In particular, occu...

Authors: Maria Larsson-Lund, Eva Månsson Lexell and Anneli Nyman

Supporting self-management and clinic attendance in young adults with type 1 diabetes: development of the D1 Now intervention

Self-management of type 1 diabetes (T1D) is complex and can be particularly challenging for young adults. This is reflected in the high blood glucose values and rates of clinic non-attendance in this group. Th...

Authors: Eimear C. Morrissey, Bláthín Casey, Lisa Hynes, Sean F. Dinneen and Molly Byrne

The impact of a digital wheeze detector on parental disease management of pre-school children suffering from wheezing—a pilot study

Viral airway infections are a major reason for doctor’s visits at pre-school age, especially when associated with wheezing. While proper treatment requires adequate recognition of airway obstruction, caretaker...

Authors: Stephanie Dramburg, Ellen Dellbrügger, Wim van Aalderen and Paolo Maria Matricardi

Reaching people soon after a traumatic event: an exploratory observational feasibility study of recruitment in the emergency department to deliver a brief behavioral intervention via smartphone to prevent intrusive memories of trauma

The current study explored how to recruit patients soon after a traumatic event, to deliver a novel intervention in a new emergency department in Sweden. This brief behavioral intervention aims to prevent intr...

Authors: Marie Kanstrup, Ann Rudman, Katarina Göransson, Emil Andersson, Klara Olofsdotter Lauri, Emma Rapoport, Linda Sunnergård, Maria Bragesjö, Erik Andersson, Lalitha Iyadurai and Emily A. Holmes

Entrepreneurship, beekeeping, and health training to decrease community violence in Dar es Salaam, Tanzania: a pilot study for an intervention trial

High unemployment rates and limited access to resources, services, and economic opportunities are associated with many types of violence. In Dar es Salaam, Tanzania, most violence is experienced by unemployed,...

Authors: Anne H. Outwater, Alison G. Abraham, Masunga K. Iseselo, Linda Helgesson Sekei, Method R. Kazaura and Japheth Killewo

A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children—the MAP study protocol

About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide r...

Authors: Tim I. Williams, Tom Loucas, Jacqueline Sin, Mirjana Jeremic, Georgia Aslett, Melissa Knight, Sara Fincham-Majumdar and Fang Liu

Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service

The Needs in Recovery Assessment (NiRA) is a newly developed needs assessment tool, designed to identify the needs of people recovering from mental illness. This tool has been evaluated outside of the clinical...

Authors: Ellen L. Davies, Andrea L. Gordon, Kenneth J. Hooper, Robert E. Laing, Elizabeth A. Lynch, Lemuel J. Pelentsov, Adrian J. Esterman and Gillian Harvey

Feasibility, experiences and outcomes of using DIALOG+ in primary care to improve quality of life and mental distress of patients with chronic conditions: an exploratory non-controlled trial in Bosnia and Herzegovina, Colombia and Uganda

DIALOG+ is a resource-oriented and evidence-based intervention to improve quality of life and reduce mental distress. While it has been extensively studied in mental health care, there is little evidence for h...

Authors: Francois van Loggerenberg, Michael McGrath, Dickens Akena, Harriet Birabwa-Oketcho, Camilo Andrés Cabarique Méndez, Carlos Gómez-Restrepo, Alma Džubur Kulenoviĉ, Maja Muhić, Nelson K. Sewankambo, Hana Sikira and Stefan Priebe

Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS)

While using an inhaled corticosteroid (ICS) in the weeks after an ED visit reduces repeat visits, few children receive a needed prescription. Because a prescription may not be filled or used, dispensing ICS at...

Authors: Lynn B. Gerald, Joe K. Gerald, John M. VanBuren, Ashley Lowe, Cecilia C. Guthrie, Eileen J. Klein, Andrea Morrison, Emily Startup and Kurt Denninghoff

Factors affecting participant recruitment and retention in borderline personality disorder research: a feasibility study

Previous studies have shown that stigma is a major barrier to participation in psychiatric research and that individuals who participate in psychiatric research may differ clinically and demographically from n...

Authors: Julia Woo, Hamnah Shahid, Alannah Hillmer, Alamna Abdullah, Sarah Deshpande, Balpreet Panesar, Nitika Sanger and Zena Samaan

Testing an online measure of portion size selection: a pilot study concerned with the measurement of ideal portion size

Portion size is known to be a key driver of food intake. As consumed portions are often pre-planned, ‘ideal portion size’—an individual’s preferred meal size selected prior to eating—has been identified as a s...

Authors: Rochelle Embling, Michelle D. Lee, Menna Price and Laura L. Wilkinson

International study of 24-h movement behaviors of early years (SUNRISE): a pilot study from Bangladesh

The World Health Organization (WHO) released guidelines for physical activity, sedentary behavior, and sleep for children under 5 years of age in 2019. In response to these guidelines, this pilot study aimed t...

Authors: Mohammad Sorowar Hossain, Iztiba M. Deeba, Mahmudul Hasan, Katharina E. Kariippanon, Kar Hau Chong, Penny L. Cross, Shameema Ferdous and Anthony D. Okely

Pre-clinical medical student cardiac point-of-care ultrasound curriculum based on the American Society of Echocardiography recommendations: a pilot and feasibility study

Cardiac point-of-care ultrasound (POCUS) training has been integrated into medical school curricula. However, there is no standardized cardiac POCUS training method for medical students. To address this issue,...

Authors: Satoshi Jujo, Jannet J. Lee-Jayaram, Brandan I. Sakka, Atsushi Nakahira, Akihisa Kataoka, Masaki Izumo, Kenya Kusunose, Natsinee Athinartrattanapong, Sayaka Oikawa and Benjamin W. Berg

Effects of an e-learning programme on osteopaths’ back pain attitudes: a mixed methods feasibility study

The biopsychosocial model is recommended in the management of non-specific low back pain but musculoskeletal practitioners can lack skills in assessing and managing patients using a biopsychosocial framework. ...

Authors: Jerry Draper-Rodi, Steven Vogel and Annette Bishop

Small studies, big decisions: the role of pilot/feasibility studies in incremental science and premature scale-up of behavioral interventions

Careful consideration and planning are required to establish “sufficient” evidence to ensure an investment in a larger, more well-powered behavioral intervention trial is worthwhile. In the behavioral sciences...

Authors: Michael W. Beets, Lauren von Klinggraeff, R. Glenn Weaver, Bridget Armstrong and Sarah Burkart

Protocol for a pilot trial to assess the feasibility of the Move More @ Work intervention to encourage employees to take the opportunity to move (be physically active) after every 30 min of sitting

Prolonged sitting increases the risk of cardio-metabolic disease. Office-based employees are particularly susceptible to high rates of this sedentary behaviour during work hours. Laboratory studies indicate th...

Authors: Elaine A. Hargreaves, Jillian J. Haszard, Sally Shaw and Meredith C. Peddie

Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial

Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery.

Authors: Prangthip Akkaranurakkul, Srithean Lertvikool, Woradej Hongsakorn, Orawin Vallibhakara, Siriluk Tantanavipas, Krissada Paiwattananupant, Wichai Ittichaikulthol, Apirom Vongsakulyanon, Sakda Arj-Ong Vallibhakara, Makaramas Anantaburana and Areepan Sophonsritsuk

A culturally adapted brief intervention for post-traumatic stress disorder in people with severe mental illness in Botswana: protocol for a randomised feasibility trial

Research consistently reports elevated rates of exposure to traumatic events and post-traumatic stress disorder (PTSD) in people with severe mental illness (SMI). PTSD may be adequately managed with psychother...

Authors: Keneilwe Molebatsi, Lauren C. Ng and Bonginkosi Chiliza

Video-delivered emotion-focused mindfulness therapy for late- life anxiety: study protocol for a feasibility randomized controlled trial

The worldwide prevalence of anxiety in older adults is estimated at between 6 and 10%. In Canada, adults 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. Anxiety in older ...

Authors: Stacey Hatch, Dorothy Kessler, Marcia Finlayson and Soham Rej

The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting

People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treat...

Authors: M. P. Rozing, A. Jønsson, R. Køster-Rasmussen, T. D. Due, J. Brodersen, K. H. Bissenbakker, V. Siersma, S. W. Mercer, A. D. Guassora, J. Kjellberg, P. K. Kjellberg, M. H. Nielsen, I. Christensen, J. E. Bardram, F. Martiny, A. Møller…

Pilot study of a brief provider and EMR-based intervention for overweight teens with asthma

Asthma-related morbidity is increased in overweight patients, yet providers are given little guidance on how to discuss weight and asthma management with overweight teens.

Authors: Christine L. M. Joseph, Gwen L. Alexander, Mei Lu, Stacy L. Leatherwood, Rachel Kado, Heather Olden, Christina Melkonian, Cheryl A. Miree and Christine Cole Johnson

Mobile diagnostics and consultation for the prevention of the metabolic syndrome and its secondary diseases in Brandenburg—study protocol of a regional prospective cohort study: the Mobile Brandenburg Cohort

The metabolic syndrome (MetS) is a risk cluster for a number of secondary diseases. The implementation of prevention programs requires early detection of individuals at risk. However, access to health care pro...

Authors: Anne Schraplau, Andrea Block, Andreas Häusler, Pia-Maria Wippert, Michael A. Rapp, Heinz Völler, Klaus Bonaventura and Frank Mayer

Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): a feasibility trial protocol

People who self-harm are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who self-harm and may be an underlying driver of self-harm behaviour...

Authors: Pooja Saini, Anna Hunt, Peter Taylor, Catherine Mills, Caroline Clements, Helen Mulholland, Cecil Kullu, Mark Hann, Rui Duarte, Felicity Mattocks, Else Guthrie and Mark Gabbay

Developing Healthcare Team Observations for Patient Safety (HTOPS): senior medical students capture everyday clinical moments

Aviation has used a real-time observation method to advance anonymised feedback to the front-line and improve safe practice. Using an experiential learning method, this pilot study aimed to develop an observat...

Authors: E. S. Anderson, T. R. L. Griffiths, T. Forey, F. Wobi, R. I. Norman and G. Martin

Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study

A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high f...

Authors: Jonathan A. Cook, Mathew Baldwin, Cushla Cooper, Navraj S. Nagra, Joanna C. Crocker, Molly Glaze, Gemma Greenall, Amar Rangan, Lucksy Kottam, Jonathan L. Rees, Dair Farrar-Hockley, Naomi Merritt, Sally Hopewell, David Beard, Michael Thomas, Melina Dritsaki…

Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial

The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis.

Authors: Julie Midtgaard, Helle Schnor, Eik D. Bjerre, Tobias Jespersen, Nina Jelsøe, Nanna Frølund, Søren Seier, Jacob W. Rønbøg, Nikolai B. Nordsborg and Bjørn H. Ebdrup

Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients’ in-hospital sleep

Sleep disturbances in hospitalized patients are linked to poor recovery. In preparation for a future randomized controlled trial, this pilot study evaluated the feasibility and acceptability of a multi-compone...

Authors: Noah R. Mason, Nicola M. Orlov, Samantha Anderson, Maxx Byron, Christine Mozer and Vineet M. Arora

Findings from a feasibility study of estradiol for hypogonadal women with cystic fibrosis-related bone disease

Advancements in therapies for patients with cystic fibrosis (CF) have decreased mortality, leading to increased prevalence of chronic complications including bone disease. CF-related bone disease (CFBD) is cha...

Authors: Malinda Wu, Rabindra Tirouvanziam, Neha Arora and Vin Tangpricha

Correction to: Diarrhoea Management using Over-thecounter Nutraceuticals in Daily practice (DIAMOND): a feasibility RCT on alternative therapy to reduce antibiotic use

Authors: Yanhong Jessika Hu, Xudong Zhou, Shanjuan Wang, Merlin Willcox, Colin Garner, David Brown, Taeko Becque, Beth Stuart, Zongru Han, Qin Chang, Michael Moore and Paul Little

Planning and optimising a digital intervention to protect older adults’ cognitive health

By 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. ...

Authors: Rosie Essery, Sebastien Pollet, Kirsten A. Smith, Fiona Mowbray, Joanna Slodkowska-Barabasz, James Denison-Day, Victoria Hayter, Katherine Bradbury, Elisabeth Grey, Max J. Western, Alexander Milton, Cheryl Hunter, Anne E. Ferrey, Andre Matthias Müller, Beth Stuart, Nanette Mutrie…

Developing an intervention to optimise the outcome of cardiac surgery in people with diabetes: the OCTOPuS pilot study

Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surger...

Authors: Richard I. G. Holt, Katharine Barnard-Kelly, Giorgos Dritsakis, Kerensa I. Thorne, Lauren Cohen, Elizabeth Dixon, Mayank Patel, Philip Newland-Jones, Helen Partridge, Suvitesh Luthra, Sunil Ohri, Kareem Salhiyyah, Jo Picot, John Niven and Andrew Cook

Protocol for a randomised controlled feasibility study of psychologically informed vestibular rehabilitation for people with persistent dizziness: INVEST trial

Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent ...

Authors: David Herdman, Sam Norton, Marousa Pavlou, Louisa Murdin and Rona Moss-Morris

Integrated malaria prevention in rural communities in Uganda: a qualitative feasibility study for a randomised controlled trial

A randomised controlled trial (RCT) on integrated malaria prevention, which advocates the use of several malaria prevention methods holistically, has been proposed. However, before conducting an RCT, it is rec...

Authors: David Musoke, Carol Namata, Rawlance Ndejjo, John C. Ssempebwa and Miph B. Musoke

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: preliminary cost-consequence analysis of the PD COMM pilot randomised controlled trial

The PD COMM pilot randomised controlled trial compared Lee Silverman Voice Treatment (LSVT® LOUD) with standard NHS speech and language therapy (SLT) and a control arm in people with Parkinson’s disease (PwPD)...

Authors: Sarah Scobie, Sue Jowett, Tosin Lambe, Smitaa Patel, Rebecca Woolley, Natalie Ives, Caroline Rick, Christina Smith, Marion C Brady, Carl Clarke and Cath Sackley

Coronary risk reduction intervention for siblings and offspring of patients with premature coronary heart disease: the CRISO study protocol for a randomised controlled pilot study

Research has consistently demonstrated that preventive cardiology programs have limited success, and healthy practices among high-risk individuals remain suboptimal. Furthermore, there are no current programme...

Authors: Justin Lee Mifsud, John Stephenson, Felicity Astin and Joseph Galea

Feasibility study of a digitalized nurse practitioner-led intervention to improve medication adherence in type 2 diabetes patients in Dutch primary care

The purpose of this feasibility study was to improve and implement an intervention aimed at enhancing medication adherence in sub-optimally controlled and non-adherent type 2 diabetes (T2DM) patients in primar...

Authors: Stijn Hogervorst, Marcel Adriaanse, Hella Brandt, Marcia Vervloet, Liset van Dijk and Jacqueline Hugtenburg

Feasibility, tolerance and effects of adding impact loading exercise to pulmonary rehabilitation in people with chronic obstructive pulmonary disease: study protocol for a pilot randomised controlled trial

Chronic obstructive pulmonary disease (COPD) is a disorder linked with a multitude of extra pulmonary manifestations (also known as treatable traits), including low bone mineral density (BMD). To date, no spec...

Authors: Erin Cecins, Kylie Hill, Dennis R. Taaffe, David Manners, Anne-Marie Hill, Robert U. Newton, Daniel A. Galvão and Vinicius Cavalheri

Assessing the feasibility of a classroom-based visual attention training program targeting academics for students with extremely low IQ

This feasibility study investigated the viability of implementing a cognitive-based training program (NeuroTracker) and assessing its potential effects on academic performance for adolescents with extremely lo...

Authors: Catherine Archambault, Domenico Tullo, Emma Clark, Jocelyn Faubert and Armando Bertone

Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol

In this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted interve...

Authors: Lauren C. Ng, Eyerusalem Getachew Serba, Benyam W. Dubale, Abebaw Fekadu and Charlotte Hanlon

A feasibility trial of an intervention in alcohol dependence for structured preparation before detoxification versus usual care: the SPADe trial results

Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members...

Authors: Christos Kouimtsidis, Ben Houghton, Heather Gage, Caitlin Notley, Vivienne Maskrey, Allan Clark, Richard Holland, Anne Lingford-Hughes, Bhaskar Punukollu, Morro Touray and Theodora Duka

Acceptability and feasibility of peer-administered group interpersonal therapy for depression for people living with HIV/AIDS—a pilot study in Northwest Ethiopia

Psychological treatments are widely tested and have been effective in treating depressive symptoms. However, implementation of psychological treatments in the real world and in diverse populations remains diff...

Authors: Biksegn Asrat, Crick Lund, Fentie Ambaw and Marguerite Schneider

Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and...

Authors: Kristina Traxler, Franz Schinabeck, Eva Baum, Edith Klotz and Barbara Seebacher

Feasibility study of the Home-based Exercises for Responsible Sex (HERS) intervention to promote correct and consistent condom use among young women

Male condoms are effective in preventing common sexually transmitted infections (STIs) and unintended pregnancy, if used correctly and consistently. However, condom use errors and problems are common and young...

Authors: Nicola Knights, Nicole Stone, Tom Nadarzynski, Katherine Brown, Katie Newby and Cynthia A. Graham

Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children

Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who ...

Authors: Gretchen Bjornstad, Beth Cuffe-Fuller, Obioha C. Ukoumunne, Mary Fredlund, Annabel McDonald, Kath Wilkinson, Jenny Lloyd, Annie Hawton, Vashti Berry, Mark Tarrant, Aleksandra Borek, Katharine Fitzpatrick, Annette Gillett, Shelley Rhodes, Stuart Logan and Christopher Morris

Protocol for mapping psychosocial screening to resources in pediatric oncology: a pilot randomized controlled trial

A pediatric cancer diagnosis and its treatment can have a detrimental effect on the mental health of children and their families. Screening to identify psychosocial risk in families has been recognized as a st...

Authors: Leandra Desjardins, Kelly Hancock, Peter Szatmari, Sarah Alexander, Wendy Shama, Claire De Souza, Denise Mills, Oussama Abla and Maru Barrera

The safety and efficacy of fecal microbiota transplantation in a population with bipolar disorder during depressive episodes: study protocol for a pilot randomized controlled trial

Bipolar disorder (BD) is a chronic, debilitating illness with significant medical morbidity, often secondary to current treatments, and a high recurrence rate. This burden of disease reflects limitations in th...

Authors: Noah C. A. Cooke, Asem Bala, Johane P. Allard, Susy Hota, Susan Poutanen and Valerie H. Taylor

Preparing for a community-based agriculture-to-nutrition trial in rural Malawi: formative research to assess feasibility and inform design and implementation decisions

This study reports findings from formative research conducted to assess the feasibility and inform the design and implementation of the Addressing Hidden Hunger with Agronomy (AHHA) trial. The AHHA trial was a...

Authors: Gabriella Chiutsi-Phiri, Alexander A. Kalimbira, Leonard Banda, Patson C. Nalivata, Marion Sanuka, Zione Kalumikiza, Limbanazo Matandika, Joseph Mfutso-Bengo, Elizabeth Allen, Elaine Ferguson, Joanna Sturgess, Martin R. Broadley, Simon Langley-Evans, Kate Millar, Dawd Gashu and Edward J. M. Joy

The headcam mother-infant interaction assessment tool: testing the feasibility and acceptability in Soweto, South Africa, using participatory engagement

Many children in low- and middle-income countries lack the stimulation needed to support healthy growth and development. Sensitive interactions between caregivers and infants may promote healthy movement behav...

Authors: Stephanie V. Wrottesley, Rebecca Pearson and Alessandra Prioreschi