Cognitive Behavioral Therapy and Light Therapy

NCT ID: NCT05337943

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2024-05-31

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.

Conditions

Pulmonary Hypertension; Insomnia; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Bright Light Therapy

Intervention Type: DEVICE

Daily light therapy for 30 minutes for 8 weeks.

Standard Care

Subjects will continue the care they routinely receive.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBT-I

Weekly sessions with a therapist to improve sleep for 8 weeks.

Intervention Type: BEHAVIORAL

Bright Light Therapy

Daily light therapy for 30 minutes for 8 weeks.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lea Ann A Matura, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

850360

Identifier Type: -

Identifier Source: org_study_id