Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
- Conditions
- Hematopoietic Stem Cell Transplant
- Interventions
- Device: Ayo wearable
- Registration Number
- NCT06496477
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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.
- Detailed Description
If you decide to be in this study, you will be asked to:
* Complete some surveys before the study begins
* Take more surveys for about 4 weeks
* Wear light therapy glasses for about 30 minutes each day for about 4 weeks
* Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits.
* Keep a ''sleep diary" where you will mark the times that you sleep while wearing the wrist monitor.
* Complete an optional interview at the end of the study.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1-A bright blue-spectrum white light (BL Ayo wearable Participants 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 Ayo wearable Participants 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
- Primary Outcome Measures
Name Time Method Depression Efficacy Baseline 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.
- Secondary Outcome Measures
Name Time Method Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective) Baseline PROMIS Ped CAT v2.0 - Fatigue (Patient and Parent Proxy)
Magnitude and Temporality of Effect in Depression Baseline 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. Sequential assessments are to determine the magnitude of response and time to effect of the intervention between the treatment and control conditions.
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 Participants will wear actigraphy devices (the Mini Motion Logger AAM-32) for at least 3 days from day 0 - day 7 ± 3 days post-transplant (baseline sleep measures) and at least 3 days from day 21 - 28 ± 3 days post-transplant. Actigraphy devices will be distributed at day 0 and 21 ± 3 days post-transplant and collected on day 7 and 28 ± 3 days post-transplant by a research team member while completing regularly planned study visits. During the days the device is worn, participants will do so for as much time during each day as possible, with near continuous wear being recommended. The device will collect data regarding the participants sleep minutes, sleep efficiency, defined as the percentage of time in bed spent sleeping, and wake after sleep onset, defined as minutes of awakening during a sleep phase. Data will be compared between participants receiving BL versus DL interventions in our study cohort.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States