NCT05337943

Cognitive Behavioral Therapy and Light Therapy

Feasibility of Cognitive Behavioral Therapy vs. Bright Light Therapy to Treat Insomnia and Fatigue: an RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (n=12 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.

Conditions

• Pulmonary Hypertension
• Insomnia
• Fatigue

Interventions

Type	Name	Description
BEHAVIORAL	CBT-I	Weekly sessions with a therapist to improve sleep for 8 weeks.
DEVICE	Bright Light Therapy	Daily light therapy for 30 minutes for 8 weeks.

Timeline

• Start date: 2023-01-12
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2022-04-20
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

1 site across 1 country: United States