Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT01725750
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; Fatigue	Device: Bright White Light (BWL); Device: Dim Red Light (DRL)	N/A

Detailed Description

To determine the efficacy of bright white light exposure compared to dim red light exposure in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be performed. Outcome assessment will be blinded. Participants will complete a baseline battery (T1) including 72 hours of actigraphy. Participants will then be randomized to either the Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute light treatments, the baseline battery will be re-administered (T2) along with 3 more days of Actigraphy. A follow-up assessment involving the same measures will be administered 1 month-post cessation of light therapy (T3). Participant treatment allocations will be masked for research team members conducting outcome measures. Secondary outcome measures will be administered to explore the effects of light therapy on mood, daytime sleepiness, sleep quality, circadian rhythms, anxiety, cognition and life satisfaction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Post-TBI Fatigue With Light Therapy
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bright White Light (BWL) Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Device: Bright White Light (BWL); Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.; Other Names: Litebook - Bright White Light
Active Comparator: Dim Red Light (DRL) Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.	Device: Dim Red Light (DRL); A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.; Other Names: Litebook - Dim Red Light

Outcome Measures

Primary Outcome Measures

1. Multidimensional Assessment of Fatigue (MAF) [baseline, 4 weeks, 8 weeks]

   Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.

Secondary Outcome Measures

1. TBI-QOL Fatigue [baseline, 4 weeks, 8 weeks]

   The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.

2. Neuro-QOL Depression and Sleep [baseline, 4 weeks, 8 weeks]

   The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.

3. Epworth Sleepiness Scale (ESS) [baseline, 4 weeks, 8 weeks]

   The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.

4. CNS Vital Signs TBI Rehab Toolbox [baseline, 4 weeks, 8 weeks]

   The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.

5. Cognitive Failures Questionnaire [baseline, 4 weeks, 8 weeks]

   The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.

6. Neuro-QOL Anxiety [baseline, 4 weeks, 8 weeks]

   The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.

7. Actiwatch Spectrum - Acrophase [4 weeks post treatment]

   Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.

8. Actiwatch Spectrum - Mesor [4 weeks post treatment]

   Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.

9. Actiwatch Spectrum - F Statistic [4 weeks post treatment]

   Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.

10. Satisfaction With Life Scale [baseline, 4 weeks, 8 weeks]

    Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.

11. Treatment Satisfaction Questionnaire for Medication [at 4 weeks (end-of-treatment)]

    An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.

12. Credibility/Expectancy Questionnaire [at 4 weeks (end-of-treatment)]

    Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented TBI of any severity

• At least 6 months post injury

• Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue

• Age 18 or older

• English speaking

Exclusion Criteria:

• Neurological disease other than TBI

• Pregnancy (because of pregnancy fatigue)

• Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year

• Current major depressive episode or substance abuse

• Diagnosed sleep disorder or high risk for sleep apnea

• History of bipolar disorder or manic or hypomanic episodes

• Current chronic, severe headaches

• Sensitivity to bright light

• History of retinal damage or disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Wayne Gordon, PhD, Icahn School of Medicine at Mount Sinai
• Principal Investigator: Kirsten Dams-O'Connor, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 9, 2016

More Information

Publications

None provided.

• Responsible Party: Kristen Dams-O'Connor, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01725750
• Other Study ID Numbers: GCO 12-1256; HSM 12-00759; H133A120084
• First Posted: Nov 14, 2012
• Last Update Posted: Aug 7, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Kristen Dams-O'Connor, Associate Professor, Icahn School of Medicine at Mount Sinai: Traumatic Brain Injury; TBI; Fatigue; Post-TBI Fatigue; PTBIF; Depressed Mood; Excessive Daytime Sleepiness; Circadian Rhythm; Anxiety; Cognitive Dysfunction; Intervention; Treatment
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Fatigue

Study Results

Participant Flow

Recruitment Details	From October 2015-January 2017, recruitment materials were sent to previous research and support group participants, and other local TBI centers. Information was also posted online and at consumer conferences. External sites included Centre for Neuro Skills facilities and post-acute rehab centers in Bakersfield and Los Angeles, CA, and Dallas, TX.

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Period Title: Overall Study
STARTED	44	44
COMPLETED	42	34
NOT COMPLETED	2	10

Baseline Characteristics

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)	Total
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.	Total of all reporting groups
Overall Participants	44	44	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.045 (16.335)	45.182 (13.138)	46.614 (14.808)
Sex: Female, Male (Count of Participants)
Female	20 45.5%	24 54.5%	44 50%
Male	24 54.5%	20 45.5%	44 50%
Race/Ethnicity, Customized (Count of Participants)
Asian/Pacific Islander	2 4.5%	5 11.4%	7 8%
Hispanic/Latino	5 11.4%	8 18.2%	13 14.8%
Black or African American	6 13.6%	5 11.4%	11 12.5%
White	27 61.4%	23 52.3%	50 56.8%
More than one race/Other	4 9.1%	3 6.8%	7 8%
Years of education completed (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.841 (2.533)	15.651 (2.654)	15.747 (2.580)

Outcome Measures

1. Primary Outcome

Title	Multidimensional Assessment of Fatigue (MAF)
Description	Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
Baseline	33.332 (9.043)	30.531 (10.633)
4 weeks (end of treatment)	27.993 (9.993)	24.937 (10.558)
8 weeks (one month post treatment)	28.658 (12.213)	25.350 (10.895)

2. Secondary Outcome

Title	TBI-QOL Fatigue
Description	The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
Baseline	61.819 (6.255)	58.821 (7.533)
4 weeks (end of treatment)	58.071 (7.384)	55.724 (8.305)
8 weeks (one month post treatment)	58.226 (8.481)	57.252 (9.033)

3. Secondary Outcome

Title	Neuro-QOL Depression and Sleep
Description	The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
Baseline	52.893 (8.033)	82.942 (7.570)
4 weeks (end of treatment)	53.337 (8.190)	52.864 (7.896)
8 weeks (one month post treatment)	55.162 (8.193)	52.290 (9.698)

4. Secondary Outcome

Title	Epworth Sleepiness Scale (ESS)
Description	The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
baseline	9.695 (4.869)	6.970 (4.323)
4 weeks (end of treatment)	8.162 (3.927)	8.312 (3.182)
8 weeks (one month post treatment)	8.169 (4.041)	8.133 (3.899)

5. Secondary Outcome

Title	CNS Vital Signs TBI Rehab Toolbox
Description	The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
baseline	79.59 (26.260)	82.83 (21.805)
4 weeks (end of treatment)	83.19 (27.489)	77.64 (37.658)
8 weeks (one month post treatment)	86.17 (28.051)	79.10 (35.443)

6. Secondary Outcome

Title	Cognitive Failures Questionnaire
Description	The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
baseline	47.823 (16.872)	42.806 (15.175)
4 weeks (end of treatment)	45.261 (17.590)	46.564 (16.646)
8 weeks (one month post treatment)	47.503 (18.204)	45.352 (18.310)

7. Secondary Outcome

Title	Neuro-QOL Anxiety
Description	The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
baseline	55.725 (8.137)	56.253 (7.581)
4 weeks (end of treatment)	55.250 (8.929)	56.661 (7.766)
8 weeks (one month post treatment)	57.441 (8.073)	55.226 (8.828)

8. Secondary Outcome

Title	Actiwatch Spectrum - Acrophase
Description	Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs.
Time Frame	4 weeks post treatment

Outcome Measure Data

Analysis Population Description

After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box. Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL. Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.
Measure Participants	30	23
Mean (Standard Deviation) [hours]	15.68 (2.29)	15.98 (1.09)

9. Secondary Outcome

Title	Actiwatch Spectrum - Mesor
Description	Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern.
Time Frame	4 weeks post treatment

Outcome Measure Data

Analysis Population Description

After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box. Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL. Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.
Measure Participants	30	23
Mean (Standard Deviation) [score on a scale]	0.72 (0.21)	0.83 (0.25)

10. Secondary Outcome

Title	Actiwatch Spectrum - F Statistic
Description	Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep. F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern.
Time Frame	4 weeks post treatment

Outcome Measure Data

Analysis Population Description

After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and in the 23 red arm.

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box. Bright White Light (BWL): Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL. Dim Red Light (DRL): A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.
Measure Participants	30	23
Mean (Standard Deviation) [score on a scale]	1765.36 (1120.32)	2307.38 (1574.54)

11. Secondary Outcome

Title	Satisfaction With Life Scale
Description	Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
baseline	17.409 (6.956)	18.698 (7.386)
4 weeks (end of treatment)	17.622 (7.154)	18.394 (7.925)
8 weeks (one month post treatment)	17.441 (6.219)	19.900 (6.707)

12. Secondary Outcome

Title	Treatment Satisfaction Questionnaire for Medication
Description	An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.
Time Frame	at 4 weeks (end-of-treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	44	44
Median (Standard Deviation) [score on a scale]	42.455 (29.827)	47.546 (33.112)

13. Secondary Outcome

Title	Credibility/Expectancy Questionnaire
Description	Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.
Time Frame	at 4 weeks (end-of-treatment)

Outcome Measure Data

Analysis Population Description

Compared to other outcome measures, fewer CEQ records were analyzed due to participant non-compliance.

Arm/Group Title	Bright White Light (BWL)	Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.	Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
Measure Participants	43	37
Mean (Standard Deviation) [score on a scale]	-.5539 (2.577)	.4489 (2.74)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Bright White Light (BWL)		Dim Red Light (DRL)
Arm/Group Description	Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.		Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
All Cause Mortality
	Bright White Light (BWL)		Dim Red Light (DRL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	Bright White Light (BWL)		Dim Red Light (DRL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Bright White Light (BWL)		Dim Red Light (DRL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/44 (0%)
Eye disorders
Blurred vision	1/44 (2.3%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.