Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823090
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2023-03-27
Brief Title:
Light Therapy for Depression in Adolescent Outpatients
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Light Therapy for Depression in Adolescent Outpatients A Placebo lead-in Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this placebo lead-in clinical trial was to test bright light therapy BLT in adolescents with depression The main questions it aimed to answer were
1 characterize and define facilitatorsbarriers to treatment with BLT in adolescents
2 evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol
3 establish an effective safe and tolerable light dose
1 characterize and define facilitatorsbarriers to treatment with BLT in adolescents
2 evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol
3 establish an effective safe and tolerable light dose
Detailed Description:
This outpatient study was performed at Ann Robert H Lurie Childrens Hospital of Chicago The Institutional Review Boards IRB of Lurie Childrens Hospital and Northwestern University Feinberg School of Medicine approved the protocol Participants were recruited through partnering community pediatric practices namely Lake Forest Pediatrics Primary care pediatricians referred potential participants with depression and elevated scores on youth screening measures Patient Health Questionnaire-9 9 or PHQ-2 3 without endorsed suicidality
Light Therapy Protocol with Placebo Lead-in Eligible participants were provided a light box and an actigraphy wrist watch and given instructions on the use of each The active light box Carex DayLight Classic Model is a white fluorescent 4000 Kelvin unit that emits 10000 lux and measures 33cm x 40cm The placebo box emits 50 lux dim red light and appears identical to the active unit Dim red light was selected because the illumination is a plausible placebo in clinical trials of BLT for depressive disorders and produces negligible effects on circadian rhythms and mood responses Subjects were instructed to position themselves 30-36 cm from the box with their faces fully exposed to the light The actigraphy device is a Philips Spectrum Plus actigraphy watch which collects activity level and sleep information along with multiple light measurements and wearer adherence The light therapy dosing protocol was planned as follows Weeks 0-2 50 lux dim red light DRL x 30 minutesday weeks 3-4 10000 lux x 15 minutesday weeks 5-6 10000 lux x 30 minutesday weeks 6-8 10000 lux x 45 minutesday At week 2 the study coordinator KJ dispensed the 10000 lux BLT unit and picked up the dim red light box and the actigraph watch Participants and their parentguardian met with 2 study clinicians at the end of each 2-week period One study clinician RB or JP who was blinded to the participants light box use conducted a brief interview regarding mood safety and functioning and assigned a Clinical Global Impressions Scale-Severity CGI-S The other study clinician DKS subsequently met with the participant to review safety side effects and response and made recommendations on duration and timing of light box use based on level of improvement and any barriers to use Thus some patients did not receive the above dosing schedule After the 8-week active study period participants who had symptom remission were given the option to keep the light box and continue use A treatment summary and ongoing treatment recommendations were provided to all participants primary care clinicians
Adherence The study coordinator made weekly callstexts to participants to inquire about their daily exposure times and to encourage proper adherence The constraints imposed upon adolescents by schools early morning start times by 800 AM bus commutes pick up by 730 AM after school activities and part-time jobs landscaping etc are considerable Knowing this and to avoid forcing adolescents to wake earlier than preferred which can produce detrimental effects on adolescent sleep and mood to use the study light box participants agreed to initiate BLT exposure in the morning at awakening in accordance to the dosing protocol At follow up visits the non-blind clinician systematically explored whether morning use remained feasible and acceptable If not the clinician made informed clinical recommendations and recorded adjustments to the time-of-day of use midday or afternoon to ensure participants were able to consistently use the box This strategy informed investigators and participants of the optimal timing of light exposure increased adherence and strengthened the reliability of detecting response
Actigraphic Assessments Actigraphy using a wrist actigraph with a light sensor Actiwatch Spectrum Philips Respironics Healthcare Bend OR USA was used to measure a number of actigraphic-derived sleep circadian activity and light variables during the placebo and active light treatment phases
Light Therapy Protocol with Placebo Lead-in Eligible participants were provided a light box and an actigraphy wrist watch and given instructions on the use of each The active light box Carex DayLight Classic Model is a white fluorescent 4000 Kelvin unit that emits 10000 lux and measures 33cm x 40cm The placebo box emits 50 lux dim red light and appears identical to the active unit Dim red light was selected because the illumination is a plausible placebo in clinical trials of BLT for depressive disorders and produces negligible effects on circadian rhythms and mood responses Subjects were instructed to position themselves 30-36 cm from the box with their faces fully exposed to the light The actigraphy device is a Philips Spectrum Plus actigraphy watch which collects activity level and sleep information along with multiple light measurements and wearer adherence The light therapy dosing protocol was planned as follows Weeks 0-2 50 lux dim red light DRL x 30 minutesday weeks 3-4 10000 lux x 15 minutesday weeks 5-6 10000 lux x 30 minutesday weeks 6-8 10000 lux x 45 minutesday At week 2 the study coordinator KJ dispensed the 10000 lux BLT unit and picked up the dim red light box and the actigraph watch Participants and their parentguardian met with 2 study clinicians at the end of each 2-week period One study clinician RB or JP who was blinded to the participants light box use conducted a brief interview regarding mood safety and functioning and assigned a Clinical Global Impressions Scale-Severity CGI-S The other study clinician DKS subsequently met with the participant to review safety side effects and response and made recommendations on duration and timing of light box use based on level of improvement and any barriers to use Thus some patients did not receive the above dosing schedule After the 8-week active study period participants who had symptom remission were given the option to keep the light box and continue use A treatment summary and ongoing treatment recommendations were provided to all participants primary care clinicians
Adherence The study coordinator made weekly callstexts to participants to inquire about their daily exposure times and to encourage proper adherence The constraints imposed upon adolescents by schools early morning start times by 800 AM bus commutes pick up by 730 AM after school activities and part-time jobs landscaping etc are considerable Knowing this and to avoid forcing adolescents to wake earlier than preferred which can produce detrimental effects on adolescent sleep and mood to use the study light box participants agreed to initiate BLT exposure in the morning at awakening in accordance to the dosing protocol At follow up visits the non-blind clinician systematically explored whether morning use remained feasible and acceptable If not the clinician made informed clinical recommendations and recorded adjustments to the time-of-day of use midday or afternoon to ensure participants were able to consistently use the box This strategy informed investigators and participants of the optimal timing of light exposure increased adherence and strengthened the reliability of detecting response
Actigraphic Assessments Actigraphy using a wrist actigraph with a light sensor Actiwatch Spectrum Philips Respironics Healthcare Bend OR USA was used to measure a number of actigraphic-derived sleep circadian activity and light variables during the placebo and active light treatment phases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None