Cognitive Impairments, Depression, Fatigue, Hematopoietic Stem Cell Transplantation, Quality of Life, Sleep
Conditions
Brief summary
Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.
Interventions
Bright light using Litebook device.
Dim light using modified Litebook device.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Have a history of HSCT, 2. 1 to 5 years post-HSCT, 3. Relapse-free since most recent HSCT, 4. Age 21 or older, 5. English language proficient 6. Able to provide informed consent 7. Endorse subjective cognitive impairment.
Exclusion criteria
1. Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment), 2. Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation, 3. Have a history of whole brain irradiation or surgery, 4. Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes, 5. Chronic use of oral steroid medication, 6. History of systematic light exposure treatment, 7. Diagnosed sleep apnea or narcolepsy, 8. Use of photosensitizing medications, 9. Plan to travel across meridians during the study, 10. Work night, early morning, or swing shifts, 11. Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functioning (Neuropsychological Tests) | Baseline to end-of-intervention to 8 weeks after the intervention | Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressed Mood (CESD) | Baseline, Mid-intervention, End of intervention, 8 weeks later | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week. |
| Interleukin-6 | Baseline and end-of-intervention | Serum cytokine IL-6 in pg/mL |
| Pro-inflammatory Cytokine - TNF Alpha | Baseline and end-of-intervention | Serum cytokine TNF-α in pg/mL |
| C-Reactive Protein | Baseline and end-of-intervention | C-reactive protein in mg/L |
| Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | Baseline, mid-intervention, end of intervention, 8 weeks after intervention | The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored 1 indicating impairment, and ratings from 4 to 6 were scored 0 indicating no impairment. Total impairment was calculated by summing the number of impaired items. |
| Circadian Activity Rhythms (Actigraphy) | Baseline to end of intervention to 8 weeks later | F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness. |
| Sleep Quality (Pittsburgh Sleep Quality Index) | Baseline, mid intervention, end of intervention, 8 weeks later | The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality |
| Fatigue (FACIT-fatigue) | Baseline, mid-intervention, end of the intervention, 8 weeks later | This is a 13-item measure of fatigue. |
| Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Baseline, mid-intervention, end-of-intervention, 8 weeks later | Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology. |
| Quality of Life (FACT-BMT) | Baseline, End of intervention, 8 weeks post-intervention | This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usage of Light Box (Integrated Meter Measurement and Litebook Log) | Throughout intervention period (4 weeks) | Length of time light box has been used. |
| Chronotype (Morningness-eveningness Questionnaire) | Baseline | Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type. |
| Credibility/Expectancy (Credibility/Expectancy Questionnaire) | Baseline | Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term symptoms was replaced with thinking, memory and concentration problems. Higher scores represent greater credibility and outcome expectancy. |
| Treatment Satisfaction (FACT-TS) | During the 4th week of the intervention | Range between 0 and 5, with 5 meaning higher treatment satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Light 30 minutes of intervention systematic light exposure daily for 4 weeks.
Intervention systematic light exposure: Bright light using Litebook device. | 23 |
| Comparison Light 30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.
Comparison systematic light exposure: Dim light using modified Litebook device. | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Intervention Light | Total | Comparison Light |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11.2 | 56.8 years STANDARD_DEVIATION 12.1 | 55.5 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 44 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Region of Enrollment United States | 23 participants | 47 participants | 24 participants |
| Sex: Female, Male Female | 17 Participants | 30 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 11 Participants |
| Wechsler Test of Adult Reading | 105.6 units on a scale STANDARD_DEVIATION 9.5 | 108.0 units on a scale STANDARD_DEVIATION 8.3 | 110.3 units on a scale STANDARD_DEVIATION 11.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Cognitive Functioning (Neuropsychological Tests)
Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.
Time frame: Baseline to end-of-intervention to 8 weeks after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Cognitive Functioning (Neuropsychological Tests) | End of intervention | 0.24 z-score | Standard Error 0.14 |
| Intervention Light | Cognitive Functioning (Neuropsychological Tests) | 8 weeks after intervention | 0.43 z-score | Standard Error 0.14 |
| Comparison Light | Cognitive Functioning (Neuropsychological Tests) | End of intervention | 0.16 z-score | Standard Error 0.14 |
| Comparison Light | Cognitive Functioning (Neuropsychological Tests) | 8 weeks after intervention | 0.50 z-score | Standard Error 0.14 |
Circadian Activity Rhythms (Actigraphy)
F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Time frame: Baseline to end of intervention to 8 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Circadian Activity Rhythms (Actigraphy) | Baseline | 1696.19 units on a scale | Standard Error 290.49 |
| Intervention Light | Circadian Activity Rhythms (Actigraphy) | End of intervention | 1999.72 units on a scale | Standard Error 295.87 |
| Intervention Light | Circadian Activity Rhythms (Actigraphy) | 8 weeks after intervention | 1858.04 units on a scale | Standard Error 293.04 |
| Comparison Light | Circadian Activity Rhythms (Actigraphy) | Baseline | 1551.72 units on a scale | Standard Error 293.04 |
| Comparison Light | Circadian Activity Rhythms (Actigraphy) | End of intervention | 1373.88 units on a scale | Standard Error 293.04 |
| Comparison Light | Circadian Activity Rhythms (Actigraphy) | 8 weeks after intervention | 1466.82 units on a scale | Standard Error 295.87 |
C-Reactive Protein
C-reactive protein in mg/L
Time frame: Baseline and end-of-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | C-Reactive Protein | Baseline | 5.67 units on a scale | Standard Deviation 10.11 |
| Intervention Light | C-Reactive Protein | End-of-intervention | 5.95 units on a scale | Standard Deviation 15.29 |
| Comparison Light | C-Reactive Protein | Baseline | 3.68 units on a scale | Standard Deviation 3.09 |
| Comparison Light | C-Reactive Protein | End-of-intervention | 3.53 units on a scale | Standard Deviation 2.61 |
Depressed Mood (CESD)
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.
Time frame: Baseline, Mid-intervention, End of intervention, 8 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Depressed Mood (CESD) | Mid-intervention | 20.4583 units on a scale | Standard Error 1.5343 |
| Intervention Light | Depressed Mood (CESD) | Baseline | 18.6293 units on a scale | Standard Error 1.3655 |
| Intervention Light | Depressed Mood (CESD) | 8 weeks post intervention | 20.1206 units on a scale | Standard Error 1.6286 |
| Intervention Light | Depressed Mood (CESD) | End of intervention | 19.1489 units on a scale | Standard Error 1.2097 |
| Comparison Light | Depressed Mood (CESD) | 8 weeks post intervention | 19.0299 units on a scale | Standard Error 1.1423 |
| Comparison Light | Depressed Mood (CESD) | Baseline | 20.4500 units on a scale | Standard Error 1.4378 |
| Comparison Light | Depressed Mood (CESD) | End of intervention | 17.0500 units on a scale | Standard Error 1.1821 |
| Comparison Light | Depressed Mood (CESD) | Mid-intervention | 18.1000 units on a scale | Standard Error 1.0366 |
Fatigue (FACIT-fatigue)
This is a 13-item measure of fatigue.
Time frame: Baseline, mid-intervention, end of the intervention, 8 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Fatigue (FACIT-fatigue) | Baseline | 29.9804 units on a scale | Standard Error 1.7374 |
| Intervention Light | Fatigue (FACIT-fatigue) | Mid-intervention | 29.5833 units on a scale | Standard Error 2.1666 |
| Intervention Light | Fatigue (FACIT-fatigue) | End of intervention | 30.8219 units on a scale | Standard Error 1.9725 |
| Intervention Light | Fatigue (FACIT-fatigue) | 8 weeks post-intervention | 30.5041 units on a scale | Standard Error 2.1484 |
| Comparison Light | Fatigue (FACIT-fatigue) | 8 weeks post-intervention | 32.3366 units on a scale | Standard Error 1.8079 |
| Comparison Light | Fatigue (FACIT-fatigue) | Baseline | 30.0000 units on a scale | Standard Error 1.5458 |
| Comparison Light | Fatigue (FACIT-fatigue) | End of intervention | 33.7513 units on a scale | Standard Error 1.4237 |
| Comparison Light | Fatigue (FACIT-fatigue) | Mid-intervention | 33.6356 units on a scale | Standard Error 1.3701 |
Interleukin-6
Serum cytokine IL-6 in pg/mL
Time frame: Baseline and end-of-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Interleukin-6 | Baseline | 3.24 units on a scale | Standard Deviation 2.72 |
| Intervention Light | Interleukin-6 | End-of-intervention | 3.98 units on a scale | Standard Deviation 4.87 |
| Comparison Light | Interleukin-6 | Baseline | 3.24 units on a scale | Standard Deviation 1.79 |
| Comparison Light | Interleukin-6 | End-of-intervention | 3.28 units on a scale | Standard Deviation 2.6 |
Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
Time frame: Baseline, mid-intervention, end-of-intervention, 8 weeks later
Population: Participants did not always complete this measure, which accounts for why there are sometimes fewer participants than the overall number of participants analyzed at different time points. Linear mixed models allows for missing time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Baseline | 91.39 score on a scale | Standard Deviation 17.71 |
| Intervention Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Mid-intervention | 92.96 score on a scale | Standard Deviation 21.12 |
| Intervention Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | End-of-intervention | 89.04 score on a scale | Standard Deviation 19.69 |
| Intervention Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | 8 weeks later | 87.29 score on a scale | Standard Deviation 21.58 |
| Comparison Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | 8 weeks later | 92.78 score on a scale | Standard Deviation 19.47 |
| Comparison Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Baseline | 89.36 score on a scale | Standard Deviation 19.57 |
| Comparison Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | End-of-intervention | 88.90 score on a scale | Standard Deviation 19.08 |
| Comparison Light | Neurobehavioral Functioning (Frontal Systems Behavioral Scale) | Mid-intervention | 90.55 score on a scale | Standard Deviation 18.56 |
Pro-inflammatory Cytokine - TNF Alpha
Serum cytokine TNF-α in pg/mL
Time frame: Baseline and end-of-intervention
Population: Two participants did not provide blood samples at the end-of-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Pro-inflammatory Cytokine - TNF Alpha | Baseline | 7.55 units on a scale | Standard Deviation 2.49 |
| Intervention Light | Pro-inflammatory Cytokine - TNF Alpha | End-of-intervention | 7.44 units on a scale | Standard Deviation 3.26 |
| Comparison Light | Pro-inflammatory Cytokine - TNF Alpha | Baseline | 7.00 units on a scale | Standard Deviation 2.13 |
| Comparison Light | Pro-inflammatory Cytokine - TNF Alpha | End-of-intervention | 7.30 units on a scale | Standard Deviation 2.36 |
Quality of Life (FACT-BMT)
This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).
Time frame: Baseline, End of intervention, 8 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Quality of Life (FACT-BMT) | Baseline | 110.27 units on a scale | Standard Error 4.187 |
| Intervention Light | Quality of Life (FACT-BMT) | End of intervention | 116.88 units on a scale | Standard Error 3.5606 |
| Intervention Light | Quality of Life (FACT-BMT) | 8 weeks post-intervention | 112.68 units on a scale | Standard Error 4.4154 |
| Comparison Light | Quality of Life (FACT-BMT) | Baseline | 109.66 units on a scale | Standard Error 4.2157 |
| Comparison Light | Quality of Life (FACT-BMT) | End of intervention | 111.94 units on a scale | Standard Error 4.9821 |
| Comparison Light | Quality of Life (FACT-BMT) | 8 weeks post-intervention | 110.92 units on a scale | Standard Error 5.097 |
Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored 1 indicating impairment, and ratings from 4 to 6 were scored 0 indicating no impairment. Total impairment was calculated by summing the number of impaired items.
Time frame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | Mid-intervention | 6.5927 units on a scale | Standard Error 1.2457 |
| Intervention Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | Baseline | 8.5217 units on a scale | Standard Error 1.219 |
| Intervention Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | End of intervention | 4.7065 units on a scale | Standard Error 1.258 |
| Intervention Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | 8 weeks after intervention | 7.0445 units on a scale | Standard Error 1.284 |
| Comparison Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | 8 weeks after intervention | 6.2142 units on a scale | Standard Error 1.2023 |
| Comparison Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | Baseline | 7.9703 units on a scale | Standard Error 1.2023 |
| Comparison Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | Mid-intervention | 6.9583 units on a scale | Standard Error 1.1934 |
| Comparison Light | Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) | End of intervention | 5.5905 units on a scale | Standard Error 1.2023 |
Sleep Quality (Pittsburgh Sleep Quality Index)
The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Time frame: Baseline, mid intervention, end of intervention, 8 weeks later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Light | Sleep Quality (Pittsburgh Sleep Quality Index) | Baseline | 7.3157 units on a scale | Standard Error 0.7672 |
| Intervention Light | Sleep Quality (Pittsburgh Sleep Quality Index) | Mid-treatment | 6.7500 units on a scale | Standard Error 0.8544 |
| Intervention Light | Sleep Quality (Pittsburgh Sleep Quality Index) | End of treatment | 6.5296 units on a scale | Standard Error 0.7567 |
| Intervention Light | Sleep Quality (Pittsburgh Sleep Quality Index) | 8 weeks later | 6.1922 units on a scale | Standard Error 0.7345 |
| Comparison Light | Sleep Quality (Pittsburgh Sleep Quality Index) | 8 weeks later | 8.3745 units on a scale | Standard Error 0.8023 |
| Comparison Light | Sleep Quality (Pittsburgh Sleep Quality Index) | Baseline | 8.5000 units on a scale | Standard Error 0.691 |
| Comparison Light | Sleep Quality (Pittsburgh Sleep Quality Index) | End of treatment | 7.5500 units on a scale | Standard Error 0.6343 |
| Comparison Light | Sleep Quality (Pittsburgh Sleep Quality Index) | Mid-treatment | 7.7500 units on a scale | Standard Error 0.7137 |
Chronotype (Morningness-eveningness Questionnaire)
Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Light | Chronotype (Morningness-eveningness Questionnaire) | 17.91 score on a scale | Standard Deviation 3.15 |
| Comparison Light | Chronotype (Morningness-eveningness Questionnaire) | 15.65 score on a scale | Standard Deviation 4.11 |
Credibility/Expectancy (Credibility/Expectancy Questionnaire)
Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term symptoms was replaced with thinking, memory and concentration problems. Higher scores represent greater credibility and outcome expectancy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Light | Credibility/Expectancy (Credibility/Expectancy Questionnaire) | 6.9 units on a scale | Standard Deviation 1.5 |
| Comparison Light | Credibility/Expectancy (Credibility/Expectancy Questionnaire) | 6.3 units on a scale | Standard Deviation 1.4 |
Treatment Satisfaction (FACT-TS)
Range between 0 and 5, with 5 meaning higher treatment satisfaction
Time frame: During the 4th week of the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Light | Treatment Satisfaction (FACT-TS) | 2.5 units on a scale | Standard Deviation 0.8 |
| Comparison Light | Treatment Satisfaction (FACT-TS) | 2.0 units on a scale | Standard Deviation 1 |
Usage of Light Box (Integrated Meter Measurement and Litebook Log)
Length of time light box has been used.
Time frame: Throughout intervention period (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Light | Usage of Light Box (Integrated Meter Measurement and Litebook Log) | 21.1 days | Standard Deviation 7.5 |
| Comparison Light | Usage of Light Box (Integrated Meter Measurement and Litebook Log) | 21.0 days | Standard Deviation 8.7 |