Evidence map›Paper›PMID 40781930›Full record

Trial reportInternational journal of qualitative studies on health and well-being2025

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

Jessica Yu, Joseph K Burns, Eric Mikhail, Marco Solmi, Simon Hatcher, Andrew L Smith, Rébecca Robillard, Thanh Nguyen, Nicole Edgar, Tetyana Kendzerska and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of qualitative studies on health and well-being, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Jessica YuNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Joseph K BurnsNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Eric MikhailNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Marco SolmiNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Simon HatcherNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Andrew L SmithNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Rébecca RobillardDepartment of Psychiatry, University of Ottawa, Ottawa, Ontario, Canada.
Thanh NguyenNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Nicole EdgarNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Tetyana KendzerskaNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Mark KaluzienskiNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Andrea BardellNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Jess G FiedorowiczNeurosciences Program, The Ottawa Hospital/Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Funding

Cerebellar metabolism, neural circuits, and symptoms in bipolar disorderR01MH111578 · NIMH · UNIVERSITY OF IOWA · PI VINCENT A MAGNOTTA, John A Wemmie · 2017 to 2026
$5.7M
NIMH NIH HHS R01 MH111578
6 · The paper itself

Abstract

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

methodsAs 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.

resultsThe 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.

Indexed as

Bipolar DisorderEyeglassesManiaAdultFeasibility StudiesFemaleGrounded TheoryHumansInterviews as TopicMaleMiddle AgedMotivationPatient SelectionQualitative ResearchBipolar disorderblue-blocking-glassesdark therapygrounded theorymaniaqualitative study

Identifiers

PMID40781930
PMCPMC12337717

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.