Cognitive Behavioral Therapy and Light Therapy

NCT05337943 | Completed Results

• 1 other identifier: 850360
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Insomnia; Fatigue

Outcome Measures

Primary Outcomes (1)

• Retention Rate

  Number of participants who completed all study procedures.

  8 weeks

Study Arms (3)

Cognitive Behavioral Therapy-Insomnia (CBT-I)

EXPERIMENTAL

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.

Behavioral: CBT-I

Bright Light Therapy

EXPERIMENTAL

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.

Device: Bright Light Therapy

Standard Care

NO INTERVENTION

Subjects will continue the care they routinely receive.

Interventions

CBT-I BEHAVIORAL

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

Cognitive Behavioral Therapy-Insomnia (CBT-I)

Bright Light Therapy DEVICE

Daily light therapy for 30 minutes for 8 weeks.

Bright Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAH diagnosis
• Insomnia
• Fatigue

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4217, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Dr. Lea Ann Matura
• Organization: University of Pennsylvania

matura@nursing.upenn.edu

2157468819

Study Officials

• Lea Ann A Matura, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: January 12, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)