The feasibility of conducting non-pharmacological research studies in participants with mania: a grounded theory qualitative analysis of the Ottawa Sunglasses at Night study.

Background: Feasibility concerns around non-pharmacological interventions can be a barrier against clinical research in individuals with mania.

Methods: As part of a randomized controlled trial using blue-blocking vs lightly-tinted glasses, we interviewed participants who were hospitalized with mania and clinicians to gather insight on feasibility of recruitment and acceptability and implementation of tinted glasses according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework using a grounded theory approach. Semi-structured interviews with 24 participants and 10 clinicians were conducted.

Results: The central theory of "research readiness for a dark therapy trial" was developed from six main themes identified from participant interviews: motivation, patient-centred approach, benefits of participating, research understanding, efficacy of intervention and challenges. The central theory of "supportive of blue-blocking glasses" was developed from five themes identified from clinician interviews: importance and benefits of clinical research, clinician-patient interactions, acceptability of research for participants, documentation and challenges.

Discussion: This study identified themes from the experiences of participants and clinicians of the clinical trial that contribute to the feasibility and acceptability of blue-blocking glasses as an intervention for mania. The results of this qualitative study will inform implementation practices for clinical trials investigating non-pharmacological interventions for hospitalized individuals with mania and related acute psychiatric conditions which affect judgement.