Our studies

Full Study Title: Making positive moves: What support do people with Learning Disabilities need to remain living in the community after moving under the Transforming Care Programme. A qualitative longitudinal study.

Study Summary: The Making Positive Moves study aims to find out what helps and hinders people with learning disabilities to stay living in the community long-term after living in hospital. The study conducts interviews with people with learning disabilities who have moved from hospital to the community at two time points, approximately one year apart.

Chief Investigator: Dr Louise Rhodes

Project Lead: Dr Silvana Mengoni

Study Time Period: April 2020 - August 2023

Sponsor(s): University of Hertfordshire and Hertfordshire Partnership University NHS Foundation Trust (HPFT)

Funder:  NIHR

Twitter: @moves_positive

Instagram: @makingpositivemoves

Facebook: Making Positive Moves

YouTube: Making Positive Moves YouTube Channel

Publications:

Head et al. (2018). Transforming identities through Transforming Care: How people with learning disabilities experience moving out of hospital.

Head et al. (2021). “It was really good, she sort of took some words what happened, like what I would say”: Adapting dyadic interview techniques to capture the stories of marginalised voices in research.

Full Study Title: The Reflective Fostering Programme – improving the wellbeing of children in care through a group intervention for foster carers: a randomised controlled trial

Study Summary: An RCT to evaluate the Reflective Fostering Programme which has been developed to develop mentalising skills in foster carers so that their relationship with the children they care for improves.

Information Video:  Reflective Fostering Programme: An Introduction video

Chief Investigator: Prof Nick Midgley

Project Lead: Dr Karen Irvine

Study Time Period: April 2020 - December 2024

Sponsor(s): University of Hertfordshire

Funder:  NIHR

Twitter: @fosteringstudy

Publications:

Midgley, N., et al (2021). The Reflective Fostering Programme—improving the wellbeing of children in care through a group intervention for foster carers: a randomised controlled trial. Trials, 22(1), 1-23.

Full Study Title: Boosting Societal Adaptation and Mental Health in a Rapidly Digitalizing, Post-Pandemic Europe

Study Summary: Our ambition is to mitigate the mental health burden of, and aid psychosocial adjustment to, the challenges of rapidly increasing digitalization among adolescents (aged 12-16y) as we look beyond the COVID-19 pandemic. Bootstrap’s aim is to initiate health and social policy and practice change to reduce the harmful effects of digitalization on young people’s mental health.

Chief Investigator(s): Prof Naomi Fineberg

Trial Manager: Natalie Hall

Study Time Period: July 2023 - June 2028

Sponsor(s): IDIBELL

Funder: Horizon Europe, UK Organisations UKRI

Website: Bootstrap

Full Study Title: The IM-Adapted Study

Study Summary:  The Inspirited Minds Adapted Intervention: Feasibility Study of a Faith-Based Culturally Adapted Intervention to Promote Mental Health and Well-Being in Young Muslim Women

Study Summary:  We will evaluate a programme developed by Inspirited Minds (IM), a Muslim charity which aims to help promote and improve the mental health and well-being of young Muslim women aged 18-24 years. The IM programme consists of group therapy sessions that have been specially developed to reflect the Muslim faith and culture. We want to find out: 1. Whether it is possible to compare the IM programme with a typical mental health programme (like that on the National Health Service) 2. How well our plans and ways of collecting information work.

Chief Investigator(s):  Prof. Daksha Trivedi

Trial Manager:  Megan Smith

Study Time Period:  March 2024 - February 2026

Sponsor(s): University of Hertfordshire

Funder: NIHR

Website: IM-Adapted

Full Study Title: Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms

Study Summary: This study tests whether small electrical currents applied to the scalp can help treat obsessive compulsive disorder (OCD). Some current passes into the brain where it may change brain functioning. Evidence suggests this could help ease OCD symptoms. This type of brain stimulation is new and experimental, so this project aims to answer basic questions, including if it shows signs of working, what are the side effects and if doctors and patients are willing to use it. The project also looks at which areas of the brain should be targeted and how long the effects last. This information would help design and implement larger clinical trials.

Chief Investigator: Prof Naomi Fineberg

Trial Manager: Megan Smith

Period: December 2018 - August 2021

Sponsor(s): University of Hertfordshire and Hertfordshire Partnership University NHS Foundation Trust (HPFT)

Funder(s): NIHR &  Orchard OCD

Publications:

Fineberg, N. A., Cinosi, E., Smith, M. V., Busby, A. D., Wellsted, D., Huneke, N. T., ... & Baldwin, D. S. (2023). Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial. Comprehensive Psychiatry, 152371.

Cinosi, E., et al. (2021). Feasibility and acceptability of transcranial stimulation in obsessive–compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive–compulsive disorder (OCD). Pilot and Feasibility Studies, 7(1), 1-16.

Full Study Title: Evaluating the effectiveness of Mentalization-Based Treatment (MBT) as an intervention for children in foster care with emotional or behavioural problems: a phase II (feasibility) randomised controlled trial)

Study Summary: A two-arm, randomised control feasibility trial to explore the acceptability and credibility of mentalization-based treatment (MBT) as a treatment for reducing emotional and behavioural difficulties in looked after children and to test the possibility of addressing a number of methodological challenges to conducting high-quality research with this population. MBT is a relatively new intervention which, in the adaptation of the model tested here, includes many of the features of therapy identified in NICE guidelines as necessary to support children in care. The two arms are MBT and usual clinical care (UCC).

Chief Investigator: Dr Nick Midgley

Trial Manager: Dr Sarah Jane Besser

Period: March 2016 - February 2018

Sponsor(s): Anna Freud Centre

Funder(s): NIHR RfPB Grant Reference: PB-PG-0614-34079

Publications:

Midgley, N., Besser, S. J., Dye, H., Fearon, P., Gale, T., Jefferies-Sewell, K., ... & Wood, S. (2017). The Herts and minds study: evaluating the effectiveness of mentalization-based treatment (MBT) as an intervention for children in foster care with emotional and/or behavioural problems: a phase II, feasibility, randomised controlled trial. Pilot and feasibility studies, 3(1), 1-12.

Full Study Title: A randomised controlled feasibility trial comparing the clinical and cost effectiveness of cognitive behavioural therapy (CBT) and selective serotonin reuptake inhibitors (SSRI) and their combination in the management of obsessive compulsive disorder.

Study Summary: A three-arm, multicentre, randomized, feasibility trial. This 52-week feasibility study was designed to inform the design of a definitive RCT, to determine the clinical-effectiveness and cost-effectiveness of combining Cognitive Behavioural Therapy (CBT) with selective serotonin reuptake inhibitor (SSRI) versus either treatment when given alone, in patients not known to be treatment resistant. The treatment arms were SSRI monotherapy, CBT monotherapy, and the combination of SSRI and CBT. The trial assessed adult participants (18–65 years) over 52 weeks with measures taken at weeks 0, 2, 4, 8, 16, 32 and 52.

Chief Investigator: Prof Naomi Fineberg

Trial Manager: Solange Wyatt

Period: July 2014 - July 2017

Sponsor(s): Hertfordshire Partnership University NHS Foundation Trust and University of Hertfordshire

Funder(s): NIHR RfPB

Publications:

Fineberg, N. A., Baldwin, D. S., Drummond, L. M., Wyatt, S., Hanson, J., Gopi, S., ... & Wellsted, D. (2018). Optimal treatment for obsessive compulsive disorder: a randomized controlled feasibility study of the clinical-effectiveness and cost-effectiveness of cognitive-behavioural therapy, selective serotonin reuptake inhibitors and their combination in the management of obsessive compulsive disorder. International clinical psychopharmacology, 33(6), 334.

Full Study Title: Feasibility study of a randomised controlled trial to investigate the effectiveness of using a humanoid robot to improve the social skills of children with an Autism Spectrum Disorder

Study Summary: A feasibility study comparing the social skills of children who interact with Kaspar and children who interact with a researcher only. Children newly diagnosed with Autism Spectrum Disorder (ASD) were randomly allocated to one of the two groups. The feasibility study examined how many families can be recruited to the study, whether the intervention is acceptable to them, how easy it is to complete the outcome measures of interest, and glean parent perspectives on their experience in the different groups. The latter will be achieved via qualitative interviews. The feasibility study is the first step towards trialling an intervention that may have benefits for child and parent well-being.

Chief Investigator: Dr Deepshika Thakur

Trial Manager: Dr Karen Irvine

Period: August 2011 - July 2016

Sponsor(s): Hertfordshire Community NHS Trust (HCT) and University of Hertfordshire (UH)

Funder(s): NIHR RfPB Grant Reference: PG-02150-36122

Publications:

Mengoni, S. E., Irvine, K., Thakur, D., Barton, G., Dautenhahn, K., Guldberg, K., ... & Sharma, S. (2017). Feasibility study of a randomised controlled trial to investigate the effectiveness of using a humanoid robot to improve the social skills of children with autism spectrum disorder (Kaspar RCT): A study protocol. BMJ open, 7(6), e017376.

Full Study Title: A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities

Study Summary: WIELD aimed to investigate the feasibility of a full-scale randomised controlled trial of a picture book to improve quality of life for people with epilepsy and learning disabilities. Participants in the intervention group used a picture book with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a book at the end of the study. All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.

Chief Investigator: Prof Bob Gates

Trial Manager: Dr Silvana Mengoni

Study Time Period: February 2014 - March 2016

Sponsor(s): Hertfordshire Partnership University NHS Foundation Trust (HPFT)

Funder(s): NIHR

Publications:

Mengoni, S. E., Gates, B., Parkes, G., Wellsted, D., Barton, G., Ring, H., ... & Durand, M. A. (2016). Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial. BMJ open, 6(11), e012993.

Mengoni, S. E., Gates, B., Parkes, G., Wellsted, D., Barton, G., Ring, H., ... & Durand, M. A. (2016). “Sometimes, it just stops me from doing anything”: A qualitative exploration of epilepsy management in people with intellectual disabilities and their carers. Epilepsy & Behavior, 64, 133-139.

Durand, M. A., Gates, B., Parkes, G., Zia, A., Friedli, K., Barton, G., ... & Wellsted, D. (2014). Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial. Trials, 15(1), 1-9.

Full Study Title: Can very low dose rivaroxaban (VLDR) in addition to Dual Antiplatelet Therapy (DAPT) improve thrombotic status in Acute Coronary Syndrome (ACS)

Study Summary: A prospective, randomised, open label study of 3 clinically licensed treatments for ACS to assess the effects of these treatments on blood tests of endogenous fibrinolysis. 50 patients will be randomised to each of the 3 treatment arms in 1:1:1 ratio. Patients receive the randomised treatment for 1 month after their index admission with ACS.

Chief Investigator: Prof Diana Gorog

Trial Manager: Megan Smith

Study Time Period: January 2019 - December 2022

Sponsor(s): East and North  Hertfordshire NHS Trust

Funder:  Bayer, PLC

Full Study Title: The clinical and cost-effectiveness of an exercise intervention for depression in adolescents: a phased, multi-site randomised controlled trial

Study Summary: The READY Trial is investigating whether physical activity is an effective treatment for young people (aged-13-17) with low mood or depression. Participants take part in either high intensity, low intensity or a social activity programme twice a week for 12 week, completing questionnaires on depression, QoL, self-esteem, service use and physical activity at various stages.

Information Video: The Ready Trial Introduction video

Chief Investigator: Prof Daksha Trivedi and Dr David Wellsted

Trial Manager: Megan Smith

Study Time Period: October 2019 - September 2022

Sponsor(s): University of Hertfordshire

Funder:  NIHR

Study Website: www.readytrial.co.uk

Twitter: @readytrial

Facebook: /READYTrial

Publications:

Howlett, N., et al (2021). A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol. Pilot and Feasibility Studies, 7(1), 1-19.

Bottoms, L., et al (2021). Energy matching of a high-intensity exercise protocol with a low-intensity exercise protocol in young people. Sport Sciences for Health, 17(4), 1035-1038.

Full Study Title: A national study of practice patterns in renal services in the identification and management of depression in people with chronic kidney disease

Study Summary: The aim of this project is to understand current national practice patterns for the identification and management of depression in CKD, in order to recommend clinical pathways for the identification and management of depression in CKD, which can be tested in future studies.

Chief Investigator(s): Prof Ken Farrington and Dr Joseph Chilcot

Trial Manager: Dr Joseph Chilcot

Study Time Period: June 2020 - September 2023

Sponsor(s): Kings College London

Funder:  Kidney Research UK and The Stoneygate Trust (KS_RP_006_20190919)

Publications:

Pearce, C. J., Hall, N., Hudson, J. L., Farrington, K., Tucker, M. J. R., Wellsted, D., ... & Chilcot, J. (2022). Approaches to the identification and management of depression in people living with chronic kidney disease: A scoping review of 860 papers. Journal of Renal Care.