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Completed

NCT Number: NCT05337943

Cognitive Behavioral Therapy and Light Therapy

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Dyssomnias Fatigue Hypertension Hypertension, Pulmonary Insomnia Lung Diseases Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I

Behavioral

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

Bright Light Therapy

Device

Daily light therapy for 30 minutes for 8 weeks.

Primary outcomes

  1. Retention Rate

    Time frame: 8 weeks

    Number of participants who completed all study procedures.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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