Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05337943
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2022-04-13
Brief Title:
Cognitive Behavioral Therapy and Light Therapy
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Feasibility of Cognitive Behavioral Therapy vs Bright Light Therapy to Treat Insomnia and Fatigue an RCT
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Cognitive behavioral therapy CBT-I is a common treatment for insomnia that does not use medications While CBT-I is effective for insomnia it does not tend to improve the waking symptom of fatigue Another treatment Bright Light Therapy is used for treating seasonal depression and sleep disorders and may improve fatigue and physical activity in individuals with PAH The purpose of this study to assess the effects of Bright Light Therapy compared to CBT-I to treat insomnia and fatigue in patients with PAH
Detailed Description:
In a single site 3-arm Cognitive Behavioral Therapy CBT-I group Bright Light Therapy group Standard of Care group parallel randomized controlled trial we will enroll 36 subjects n12 per group to assess the feasibility of Bright Light Therapy compared to CBT-I in subjects with pulmonary arterial hypertension PAH to treat insomnia difficulty initiating sleep or maintaining sleep and fatigue
To assess the recruitment and retention rates of CBT-I and Bright Light Therapy
To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on insomnia and fatigue severity and secondary wake after sleep onset and sleep onset latency outcomes
To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity
To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes depression dyspnea and QOL
To assess the recruitment and retention rates of CBT-I and Bright Light Therapy
To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on insomnia and fatigue severity and secondary wake after sleep onset and sleep onset latency outcomes
To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity
To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes depression dyspnea and QOL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None