Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
2 other identifiers
interventional
98
1 country
1
Brief Summary
The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances. Primary Objective To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant. Secondary Objectives
- To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT.
- To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant.
- To evaluate the response of BL therapy versus DL on sleep quality. Exploratory Objectives
- To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
- To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 10, 2026
February 1, 2026
9 months
November 9, 2023
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression Efficacy
Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period.
Baseline
Secondary Outcomes (3)
Magnitude and Temporality of Effect in Depression
Baseline
Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective)
Baseline
Impact on Sleep Quality"
Actigraphy devices will be worn for at least 3 days from day 0 - day 7 ± 3 days post-transplant and at least 3 days from day 21 - 28 ± 3 days post-transplant
Other Outcomes (5)
Impact on Delirium Incidence
observed for the entire duration of the intervention
Participant Perceptions of Light Therapy
day 28 ± 3 days post-transplant
Adherence
Day 1 to Day 28 ± 3 days post-transplant, once daily, between the hours of 6 AM and 3 PM CST for a period not to exceed 30 minutes.
- +2 more other outcomes
Study Arms (2)
Group 1-A bright blue-spectrum white light (BL
ACTIVE COMPARATORParticipants will receive therapy with bright blue-spectrum white light (BL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission
Group 2- A dim blue-spectrum white light control (DL
ACTIVE COMPARATORParticipants will receive therapy with dim blue-spectrum white light control (DL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission
Interventions
Primary study device - the Ayo wearable which are glasses that emit either bright blue-spectrum white light or dim blue-spectrum white light or Mini motion logger AAM-32 - an actigraphy device work during the first and last week of the study on the participants wrist throughout most of the day, measuring activity. This will be used as an indicator of sleep.
Eligibility Criteria
You may qualify if:
- Age ≥8 to \<18 years of age at the time of enrollment
- Allogeneic HSCT planned to occur between 7 and 10 days in the future from recruitment
- Patient and/or primary caregiver reads and writes in English or Spanish
- Participant/guardian is willing to sign informed consent
- Optional interview participants must be English speaking
- Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) ≥ 55
You may not qualify if:
- Taking photosensitizing medications
- Total blindness / complete lack of light perception bilaterally
- Significant physiological or psychological impairment that interferes with participation
- Any patient that, in the opinion of the primary investigator is not appropriate for the study
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Non-English-speaking participants will not be eligible for the optional qualitative interview
- Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) \< 55
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Elliott, MD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
July 11, 2024
Study Start
April 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.