Cognitive Behavioral Therapy and Light Therapy

Not Applicable

Completed

• Conditions: Pulmonary Hypertension; Insomnia; Fatigue
• Interventions: Device: Bright Light Therapy; Behavioral: CBT-I

• Registration Number: NCT05337943
• Lead Sponsor: University of Pennsylvania

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 (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.

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2023-01-12
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Results First Submitted: 2024-10-07
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Results First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• PAH diagnosis
• Insomnia
• Fatigue

Exclusion Criteria

• Untreated obstructive sleep apnea
• Subjects with left-sided valvular disease
• Hospitalized or acutely ill
• Any eye disease such as, but not limited to, cataracts, glaucoma, retinal disorders (e.g. macular degeneration), or previous eye surgery
• Subjects with photosensitivity (e.g. epilepsy)
• Manic-depressive psychosis or Bipolar Disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright Light Therapy	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.
Cognitive Behavioral Therapy-Insomnia (CBT-I)	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.

Primary Outcome Measures

Name	Time	Method
Retention Rate	8 weeks	Number of participants who completed all study procedures.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States