Trial Outcomes & Findings for Cognitive Behavioral Therapy and Light Therapy (NCT NCT05337943)
NCT ID: NCT05337943
Last Updated: 2025-01-27
Results Overview
Number of participants who completed all study procedures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy-Insomnia (CBT-I)
CBT-I treatment will receive 1 session every week, for 8 weeks (8 total sessions). The CBT-I sessions will be provided by a pool of clinical PhD psychology students by a trained professional. Each visit will be conducted via telehealth. Sessions will include discussions regarding such topics as sleep restriction, stimulus control and sleep hygiene. Review of sleep diaries will occur during the sessions.
CBT-I: Weekly sessions with a therapist to improve sleep for 8 weeks.
|
Bright Light Therapy
Bright Light treatment will consist of 8 weeks of daily use of the Re-timer device. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of \~500 lux lm/m2. Subjects will be instructed to use the device for 30 minutes within two hours of waking, in the morning on the full brightness setting.
Bright Light Therapy: Daily light therapy for 30 minutes for 8 weeks.
|
Standard Care
Subjects will continue the care they routinely receive.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Therapy and Light Therapy
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy-Insomnia (CBT-I)
n=1 Participants
CBT-I treatment will receive 1 session every week, for 8 weeks (8 total sessions). The CBT-I sessions will be provided by a pool of clinical PhD psychology students by a trained professional. Each visit will be conducted via telehealth. Sessions will include discussions regarding such topics as sleep restriction, stimulus control and sleep hygiene. Review of sleep diaries will occur during the sessions.
CBT-I: Weekly sessions with a therapist to improve sleep for 8 weeks.
|
Bright Light Therapy
n=3 Participants
Bright Light treatment will consist of 8 weeks of daily use of the Re-timer device. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of \~500 lux lm/m2. Subjects will be instructed to use the device for 30 minutes within two hours of waking, in the morning on the full brightness setting.
Bright Light Therapy: Daily light therapy for 30 minutes for 8 weeks.
|
Standard Care
n=2 Participants
Subjects will continue the care they routinely receive.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 17.8 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 21.2 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Enrollment Arms
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The participant randomized to CBT-I withdrew from the study.
Number of participants who completed all study procedures.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia (CBT-I)
n=1 Participants
CBT-I treatment will receive 1 session every week, for 8 weeks (8 total sessions). The CBT-I sessions will be provided by a pool of clinical PhD psychology students by a trained professional. Each visit will be conducted via telehealth. Sessions will include discussions regarding such topics as sleep restriction, stimulus control and sleep hygiene. Review of sleep diaries will occur during the sessions.
CBT-I: Weekly sessions with a therapist to improve sleep for 8 weeks.
|
Bright Light Therapy
n=3 Participants
Bright Light treatment will consist of 8 weeks of daily use of the Re-timer device. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of \~500 lux lm/m2. Subjects will be instructed to use the device for 30 minutes within two hours of waking, in the morning on the full brightness setting.
Bright Light Therapy: Daily light therapy for 30 minutes for 8 weeks.
|
Standard Care
n=2 Participants
Subjects will continue the care they routinely receive.
|
|---|---|---|---|
|
Retention Rate
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Cognitive Behavioral Therapy-Insomnia (CBT-I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bright Light Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place