Clocks In Sync: A mixed methods pilot feasibility trial of blue-light blocking therapy and time-restricted eating, alone or in combination for mania in bipolar disorder.

Authors

Jess G Fiedorowicz, Eric Mikhail, Jessica Ward-King, Marco Solmi, Sara Siddiqi, Lauren Bricker, Nat Leduc, Mahsa Jormand, Joseph K Burns, Jessica Yu, Rébecca Robillard, Gayatri Saraf, Clocks In Sync Investigators and Coordinators

Published in

Journal of affective disorders. Pages 122720. Nov 08, 2026. Epub Nov 08, 2026.

Abstract

Sleep and circadian disruptions are common in bipolar disorder (BD). Persons with lived and living experience (PWLEs) find chronotherapies to be of great interest, especially blue-blocking glasses (BBG, targeting the central biological clock) and time-restricted eating (TRE, targeting peripheral clocks).
We conducted a mixed methods randomized, three group parallel pilot trial (clinicaltrials.gov: NCT06504342) to assess the feasibility of BBG and/or TRE (10: 14 of diurnal eating to nocturnal fasting informed by PWLE input) as an adjunctive treatment for inpatients with DSM-5-defined mania and a Young Mania Rating Scale (YMRS) ≥ 20. Participants were randomized 1:1:1 to TRE (BBG-/TRE+), BBG (BBG+/TRE-) or both (BBG+/TRE+). Feasibility was assessed through monitoring of adherence and qualitative semi-structured interviews with participants and staff were conducted to identify any challenges/barriers to implementation, and what supports might be needed. Change in the YMRS from blinded raters was a secondary outcome.
Twenty-one eligible participants consented for the trial and 80% of participants (16/20) were mostly adherent or better with no differences in adherence across groups. Qualitative data highlights patient interest in chronotherapy interventions and staff support of integrating them in practice. There was also interest in shorter or flexible timing of the studied chronotherapies. Greater improvements were observed in the BBG+ groups compared to BBG-/TRE+ on the YMRS.
Most inpatients with BD can adhere to circadian interventions requiring active participation in high acuity, inpatient settings. Our pilot study may inform future studies or clinical implementation of these and other low cost and scalable chronotherapies.

PMID:
43000070
Bibliographic data and abstract were imported from PubMed on 09 Nov 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.