Cognitive Behavioral Therapy and Light Therapy

Last updated: January 23, 2025
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

High Blood Pressure (Hypertension)

Chest Pain

Congestive Heart Failure

Treatment

Bright Light Therapy

CBT-I

Clinical Study ID

NCT05337943
850360
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PAH diagnosis

  • Insomnia

  • Fatigue

Exclusion

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

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Bright Light Therapy
Phase:
Study Start date:
January 12, 2023
Estimated Completion Date:
May 31, 2024

Study 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.

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104-4217
    United States

    Site Not Available

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