Pilot study of a ketogenic diet in bipolar disorder: a process evaluation

Abstract Background Bipolar disorder is a serious mental illness, which requires new strategies for prevention and management. Recent evidence suggests that a ketogenic diet may be an effective intervention. This research aimed to explore the feasibility and acceptability of a ketogenic diet interve...

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Main Authors: Benjamin P. Rigby, Nicole Needham, Helen Grossi, Ivana Kamenska, Iain H. Campbell, Ben Meadowcroft, Frances Creasy, Cheryl Fisher, Pankaj Bahuguna, John Norrie, Gerard Thompson, Melissa C. Gibbs, Maja Mitchell-Grigorjeva, Ailsa McLellan, Tessa Moses, Karl Burgess, Rachel Brown, Michael J. Thrippleton, Harry Campbell, Daniel J. Smith, Sharon A. Simpson
Format: Article
Language:English
Published: BMC 2025-01-01
Series:BMC Psychiatry
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Online Access:https://doi.org/10.1186/s12888-025-06479-y
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author Benjamin P. Rigby
Nicole Needham
Helen Grossi
Ivana Kamenska
Iain H. Campbell
Ben Meadowcroft
Frances Creasy
Cheryl Fisher
Pankaj Bahuguna
John Norrie
Gerard Thompson
Melissa C. Gibbs
Maja Mitchell-Grigorjeva
Ailsa McLellan
Tessa Moses
Karl Burgess
Rachel Brown
Michael J. Thrippleton
Harry Campbell
Daniel J. Smith
Sharon A. Simpson
author_facet Benjamin P. Rigby
Nicole Needham
Helen Grossi
Ivana Kamenska
Iain H. Campbell
Ben Meadowcroft
Frances Creasy
Cheryl Fisher
Pankaj Bahuguna
John Norrie
Gerard Thompson
Melissa C. Gibbs
Maja Mitchell-Grigorjeva
Ailsa McLellan
Tessa Moses
Karl Burgess
Rachel Brown
Michael J. Thrippleton
Harry Campbell
Daniel J. Smith
Sharon A. Simpson
author_sort Benjamin P. Rigby
collection DOAJ
description Abstract Background Bipolar disorder is a serious mental illness, which requires new strategies for prevention and management. Recent evidence suggests that a ketogenic diet may be an effective intervention. This research aimed to explore the feasibility and acceptability of a ketogenic diet intervention for bipolar disorder, fidelity to its behavioural components and the experiences of the participants and research clinicians involved. Methods A mixed-methods process evaluation was conducted. Semi-structured telephone interviews were carried out with 15 participants 1–2 months after completing a 6–8 week modified ketogenic diet intervention, and 4 research clinicians from the study team following the completion of data collection. Data were thematically analysed. Fidelity checklists completed by research dietitians were analysed using descriptive count and percentage statistics. Findings are reported post-hoc, following the analysis and publication of the main pilot study findings. Reporting was guided by the COREQ checklist. Results Five themes were identified in the qualitative data: (1) ‘Encouraging entry and supporting exit’ (e.g. recognising and managing participants’ varied motives and expectations, including around weight loss and symptom alleviation); (2) ‘Challenging but potentially transformational,’ which reflects that while it can be difficult to initiate and maintain a ketogenic diet day-to-day, many participants perceived physical and psychological benefits (e.g. significant weight loss, mood stability and enhanced ability to focus); (3) ‘Intervention facilitators,’ including a range of behavioural (e.g. goal setting), social (e.g. family and dietitians) and technological (e.g. apps for monitoring) support mechanisms; (4) ‘Intervention barriers’ (e.g. dietary preferences, concerns about the diet and its impact, the testing burden and capacity of the delivery team); and (5) ‘The wider context’ (e.g. the cost of living and sociocultural expectations) was a crucial factor explaining differential experiences. Overall, descriptive analyses indicated moderate-to-good fidelity to the behaviour change components of the study. Conclusion We provide novel insight into the experiences of people living with bipolar disorder initiating and following a ketogenic diet, as well as those of research clinicians who support the intervention. Future trials may benefit from increased clinical research capacity, better-defined entry and exit routes, additional interpersonal support, and greater understanding of how social and societal factors impact participation. Trial registration Study registration number: ISRCTN61613198 (02/03/22).
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spelling doaj-art-95a6705715c8493ca70f44ee3977a5322025-01-26T12:46:49ZengBMCBMC Psychiatry1471-244X2025-01-0125111810.1186/s12888-025-06479-yPilot study of a ketogenic diet in bipolar disorder: a process evaluationBenjamin P. Rigby0Nicole Needham1Helen Grossi2Ivana Kamenska3Iain H. Campbell4Ben Meadowcroft5Frances Creasy6Cheryl Fisher7Pankaj Bahuguna8John Norrie9Gerard Thompson10Melissa C. Gibbs11Maja Mitchell-Grigorjeva12Ailsa McLellan13Tessa Moses14Karl Burgess15Rachel Brown16Michael J. Thrippleton17Harry Campbell18Daniel J. Smith19Sharon A. Simpson20Population Health Sciences Institute, Newcastle UniversityDivision of Psychiatry, Centre for Clinical Brain Sciences, Royal Infirmary of EdinburghDepartment of Nutrition and Dietetics, Royal Hospital for Children and Young PeopleUsher Institute, University of EdinburghDivision of Psychiatry, Centre for Clinical Brain Sciences, Royal Infirmary of EdinburghPsychiatry, NHS LothianPsychiatry, NHS LothianDepartment of Nutrition and Dietetics, Royal Hospital for Children and Young PeopleHealth Economics and Health Technology Assessment, University of GlasgowUsher Institute, University of EdinburghCentre for Clinical Brain Sciences, University of EdinburghNuffield Department of Clinical Neuroscience, University of OxfordBipolar ScotlandDepartment of Paediatric Neurology, Royal Hospital for Children and Young PeopleEdinOmics Research Facility (RRID: SCR_021838), University of EdinburghCentre for Engineering Biology, University of EdinburghCentre for Engineering Biology, University of EdinburghCentre for Clinical Brain Sciences, University of EdinburghUsher Institute, University of EdinburghDivision of Psychiatry, Centre for Clinical Brain Sciences, Royal Infirmary of EdinburghMRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of GlasgowAbstract Background Bipolar disorder is a serious mental illness, which requires new strategies for prevention and management. Recent evidence suggests that a ketogenic diet may be an effective intervention. This research aimed to explore the feasibility and acceptability of a ketogenic diet intervention for bipolar disorder, fidelity to its behavioural components and the experiences of the participants and research clinicians involved. Methods A mixed-methods process evaluation was conducted. Semi-structured telephone interviews were carried out with 15 participants 1–2 months after completing a 6–8 week modified ketogenic diet intervention, and 4 research clinicians from the study team following the completion of data collection. Data were thematically analysed. Fidelity checklists completed by research dietitians were analysed using descriptive count and percentage statistics. Findings are reported post-hoc, following the analysis and publication of the main pilot study findings. Reporting was guided by the COREQ checklist. Results Five themes were identified in the qualitative data: (1) ‘Encouraging entry and supporting exit’ (e.g. recognising and managing participants’ varied motives and expectations, including around weight loss and symptom alleviation); (2) ‘Challenging but potentially transformational,’ which reflects that while it can be difficult to initiate and maintain a ketogenic diet day-to-day, many participants perceived physical and psychological benefits (e.g. significant weight loss, mood stability and enhanced ability to focus); (3) ‘Intervention facilitators,’ including a range of behavioural (e.g. goal setting), social (e.g. family and dietitians) and technological (e.g. apps for monitoring) support mechanisms; (4) ‘Intervention barriers’ (e.g. dietary preferences, concerns about the diet and its impact, the testing burden and capacity of the delivery team); and (5) ‘The wider context’ (e.g. the cost of living and sociocultural expectations) was a crucial factor explaining differential experiences. Overall, descriptive analyses indicated moderate-to-good fidelity to the behaviour change components of the study. Conclusion We provide novel insight into the experiences of people living with bipolar disorder initiating and following a ketogenic diet, as well as those of research clinicians who support the intervention. Future trials may benefit from increased clinical research capacity, better-defined entry and exit routes, additional interpersonal support, and greater understanding of how social and societal factors impact participation. Trial registration Study registration number: ISRCTN61613198 (02/03/22).https://doi.org/10.1186/s12888-025-06479-yBipolar type I or II disordersProcess evaluationNeurophysiologyMetabolic psychiatry
spellingShingle Benjamin P. Rigby
Nicole Needham
Helen Grossi
Ivana Kamenska
Iain H. Campbell
Ben Meadowcroft
Frances Creasy
Cheryl Fisher
Pankaj Bahuguna
John Norrie
Gerard Thompson
Melissa C. Gibbs
Maja Mitchell-Grigorjeva
Ailsa McLellan
Tessa Moses
Karl Burgess
Rachel Brown
Michael J. Thrippleton
Harry Campbell
Daniel J. Smith
Sharon A. Simpson
Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
BMC Psychiatry
Bipolar type I or II disorders
Process evaluation
Neurophysiology
Metabolic psychiatry
title Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
title_full Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
title_fullStr Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
title_full_unstemmed Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
title_short Pilot study of a ketogenic diet in bipolar disorder: a process evaluation
title_sort pilot study of a ketogenic diet in bipolar disorder a process evaluation
topic Bipolar type I or II disorders
Process evaluation
Neurophysiology
Metabolic psychiatry
url https://doi.org/10.1186/s12888-025-06479-y
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