Efficacy of Bright Light Therapy on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms: Protocol for a Randomised Controlled Trial

Sponsor
Peking University Sixth Hospital
Study ID
NCT07508215
Status
Recruiting
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Conditions

  • Bright Light Treatment
  • Cognitive Impairment
  • Major Depressive Disorder (MDD)
  • Neuroimaging

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • BLT — DEVICE
    Using a hybrid white light box with independent intellectual property rights, with an intensity of 10000lux and a main wavelength of 476.4nm
  • DRL — DEVICE
    Using a dim red light box as the placebo, with an intensity of \<100lux and a main wavelength of 690.4nm

Study Details

This study aims to validate the therapeutic efficacy and safety of bright light therapy (BLT) in ameliorating cognitive impairment (CI) in major depressive disorder (MDD), characterize the functional and structural features of the hippocampus (HPC)-dorsolateral prefrontal cortex (dlPFC) neural circuitry in MDD participants with CI and examine the mediating effect of the HPC-dlPFC neural circuit on CI induced by BLT treatment in MDD participants. MDD participants will be required to only receive selective serotonin reuptake inhibitors (SSRIs) as monotherapy for at least four weeks, or medication-free status before enrollment. Eligible participants will be randomly assigned to the experimental group and the control group. The experimental group will receive the intervention of BLT, and the control group will receive the intervention of dim red light (DRL). The intervention will last for four weeks, 6 days per week, with 40 minutes each day between 7 am and 10 am. The MDD participants will be followed once in the end of each week during the 4-week intervention and in the end of the 4th week after intervention. Demographic information will be collected at baseline; cognitive function will be evaluated at baseline, weeks 2, 4, and 8 after intervention beginning; and other symptoms such as depression, anxiety and sleep were assessed at baseline, weeks 1, 2, 3, 4, and 8 after intervention beginning. Moreover, structural and functional MRI scans will be made at baseline and post-intervention. During the intervention, MDD participants will be required to keep a record of daily light exposure duration and complete the daily sleep diary as well.

Key Dates

First listed
Apr 2, 2026
Start date
Apr 10, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: DRL control group
    Eligible MDD participants will be randomly subjected to the DRL control group. The light source intensity will be set at \<100 lux and placed 0.6 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The DRL control group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for four weeks, 6 days per week.
  • Experimental: BLT experimental group
    Eligible MDD participants will be randomly subjected to the BLT experimental group. The source intensity of BLT experimental group will be set at 10000 lux and placed 0.45 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The BLT experimental group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for 4 weeks, 6 days per week.
  • No Intervention: healthy control

Primary Outcome Measure

Symbol Coding (SC) [ Time Frame: screen, baseline, weeks2, 4, and 8 ]

Central Contacts

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