The feasibility of conducting non-pharmacological research studies in participants with mania: a grounded theory qualitative analysis of the Ottawa Sunglasses at Night study
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.069 | 0.067 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.016 | 0.019 |
| Scholarly communication | 0.006 | 0.004 |
| Open science | 0.003 | 0.008 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".