ENERGISE-BD Process Evaluation
Research type
Research Study
Full title
ENERGISE-BD Process Evaluation
IRAS ID
371642
Contact name
Fiona Dobbie
Contact email
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
This study is a process evaluation of the ENERGISE-BD clinical trial (a separate ethics application has been submitted for the main trial). The ENERGISE-BD clinical trial assesses the effectiveness of a ketogenic diet as an intervention for bipolar disorder. Bipolar disorder involves recurrent episodes of depression and mania/hypomania, with many individuals experiencing persistent depressive symptoms between episodes that impair functioning and quality of life. These symptoms represent a major unmet clinical need, as current pharmacological treatments are often only partially effective and may cause significant side effects. There is therefore a need for novel, non-medication interventions. Recent evidence suggests that nutritional ketosis, specifically a ketogenic diet, may be effective in treating depressive symptoms in bipolar disorder.
In 2022, the ENERGISE-BD Trial team completed a pilot study of nutritional ketosis in 27 euthymic people with bipolar disorder. The team found that this intervention was feasible, well tolerated and acceptable to patients and was associated with both improved mental health and metabolic outcomes. Ketone levels were correlated with improved energy levels, fewer depressive symptoms, fewer anxiety symptoms and less impulsivity; additionally, weight and systolic blood pressure decreased.
The primary aim of the process evaluation is to assess the acceptability, feasibility and fidelity of the intervention from the perspectives of trial participants, staff and other key stakeholders. To address the study aims, a mixed-methods design will be employed and will include: a qualitative longitudinal cohort study with study participants; semi-structured interviews with trial delivery staff and stakeholders supporting delivery or informing discussion regarding future scalability; observation of intervention delivery; and analysis of fidelity checklists. The process evaluation will be situated in the two study sites, Edinburgh and Birmingham.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0141
Date of REC Opinion
1 Jul 2026
REC opinion
Favourable Opinion