Qualitative Lead(s)
Professor Vanessa Lawrence
Project Lead & Team
Chief Investigator: Cynthia Fu
Multidisciplinary collaboration including psychiatrists, neuroscientists, trialists, statisticians, health economists, and patient and public involvement representatives across multiple UK research sites.
Project Dates
2025–2028
Funding Source(s)
NIHR Efficacy and Mechanism Evaluation Programme (NIHR167361)
Qualitative Design used
- Qualitative Research in Trials
- Implementation Research and Improvement Science
- Evaluating Services and Interventions
Field of Research
Bipolar disorder; neuromodulation interventions; depression; clinical trials; process evaluation.
Geographic/Contextual Setting
Multi-site NHS primary care and community mental health services across the UK.
Home-based Transcranial Direct Current Stimulation in Bipolar Depression
BDEP is an ongoing NIHR EME–funded multi-centre randomised, double-blind, placebo-controlled trial evaluating the clinical efficacy, safety, and implementation of home-based transcranial direct current stimulation (tDCS) for individuals experiencing bipolar depression. The study includes an embedded qualitative component examining participant, caregiver, and clinician experiences of treatment delivery, adherence, and implementation processes to support interpretation of trial outcomes and inform future service implementation.
Qualitative Approach and Methods
Aim of the qualitative component
To explore participant, caregiver, and clinician experiences of home-based tDCS treatment for bipolar depression, including treatment acceptability, adherence, perceived impacts, and implementation considerations within routine care settings.
Qualitative methodology
A qualitative interview-based process evaluation embedded within a multi-centre randomised controlled trial.
Which qualitative methods were used?
Individual interviews are conducted with trial participants across treatment arms, alongside interviews with clinicians involved in recruitment and treatment delivery. Interviews explore experiences of treatment, trial participation, adherence, and implementation considerations.
Sampling & recruitment
Participants are recruited from individuals enrolled in the BDEP clinical trial across participating NHS sites, with purposive sampling ensuring representation across treatment arms, demographic characteristics, and clinical contexts.
Data analysis: how the team made sense of the data
Qualitative data are analysed using framework analysis, enabling examination of mechanisms influencing engagement and implementation and supporting integration of qualitative findings with trial outcomes.
Findings, Learning & Impact
Summary of main findings
Data collection and analysis are ongoing. The qualitative component is expected to generate insight into treatment acceptability, adherence, and the feasibility of implementing home-based neuromodulation treatments within NHS care pathways for bipolar depression.
Why were qualitative methods used in this project, and what did they enable?
Qualitative research enables the trial to:
- Understand participant experiences of home-based neuromodulation treatments.
- Identify barriers and facilitators to adherence and engagement.
- Examine clinician and service-level implementation considerations.
- Inform future scalability and service integration.
Lessons learnt / reflections?
As the study is ongoing, qualitative findings are being generated iteratively to inform interpretation of trial outcomes and planning of future implementation strategies.
Impact & influence
BDEP is generating acceptability and implementation evidence to inform the potential integration of home-based neuromodulation treatments into clinical pathways for bipolar depression.