EDEN

Qualitative Approach and Methods

Aim of the qualitative component

To understand how participants, carers, and clinicians experience ketamine treatment and trial participation, including perceptions of treatment benefits and disadvantages, adherence and trial acceptability, to inform future trial design.

Qualitative methodology

A longitudinal qualitative interview and diary study embedded within a randomised controlled trial to examine treatment experiences and feasibility processes over time.

Which qualitative methods were used?

• Individual interviews with trial participants at baseline and follow-up, alongside interviews with carers and clinicians involved in the study.
• Participants receiving the intervention are also invited to complete short audio or video diary entries documenting their experiences of treatment over time.

Sampling & recruitment

Participants are recruited from individuals enrolled in the EDEN clinical trial, alongside carers and clinicians involved in treatment delivery. Purposive sampling ensures representation across treatment arms, participation experiences, and clinical roles. Supporters are recruited via participating patients, who are invited to nominate a significant other involved in their everyday life. Clinicians/health professionals involved in prescribing medication are recruited purposively through professional networks across participating hospitals and clinics to capture a range of implementation and service-level perspectives.

Data analysis: how the team made sense of the data

Qualitative data will be analysed using the framework approach, enabling comparison of experiences across treatment groups, time points, and stakeholder groups, and supporting integration of qualitative findings with quantitative trial outcomes.

Findings, Learning & Impact

Summary of main findings

Data collection and analysis are ongoing. Findings are expected to provide insight into treatment acceptability, participant decision-making, adherence processes, and experiences of trial participation among individuals with severe and enduring anorexia nervosa.

Why were qualitative methods used in this project, and what did they enable?

Qualitative methods have been embedded within the EDEN feasibility trial to address questions that could not be adequately captured through quantitative feasibility metrics alone. While recruitment, retention and adherence rates indicate whether a trial can run operationally, they do not explain how participants and clinicians experience the intervention, how meaning is constructed around ketamine treatment or why particular barriers or facilitators arise. Given the clinical and psychosocial complexity of anorexia nervosa with comorbid depression, and the novelty and stigma associated with ketamine, an in-depth qualitative exploration is necessary to understand the human and contextual dimensions of feasibility.

Semi-structured interviews and optional digital diaries are used to explore participants’, carers’ and health professionals’ expectations, experiences, emotional responses and decision-making processes in relation to both the trial and ketamine treatment. These methods enable the collection of rich accounts of perceived burden, accessibility, acceptability and engagement, as well as the social, relational and ethical contexts shaping participation. Comparing pre-trial expectations with post-trial experiences further allows examination of how perceptions evolved over time. The inclusion of digital diaries provides near-real-time insights into day-to-day experiences of the trial and treatment.

What knowledge gap or complexity required qualitative inquiry?

Qualitative investigation will help to answer:

• How participants make sense of ketamine as a treatment, particularly given its psychedelic associations and stigma.
• How expectations, hope or disappointment (e.g., regarding placebo allocation) shape engagement and retention.
• The psychological and relational impacts of trial participation in a clinically vulnerable population.
• How clinicians’ attitudes, prescribing practices and service contexts influence recruitment.
• The ethical and emotional dimensions of participation, including issues of control, trust and power in research settings.

These experiential and contextual factors are not directly measurable through questionnaires or trial metrics but are critical to determining whether a future definitive trial would be acceptable and sustainable.

Impact & influence

The EDEN qualitative programme is generating acceptability evidence that will inform the development of future pharmacological trials and clinical pathways for individuals with severe and enduring anorexia nervosa and comorbid depression.