Cognitive Behavioral Therapy and Light Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Hypertension, Insomnia, Fatigue

Intervention / Treatment
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* Behavioral: CBT-I
* Device: Bright Light Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy-Insomnia (CBT-I)<br>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<br>* Weekly sessions with a therapist to improve sleep for 8 weeks.<br>|
| Experimental: Bright Light Therapy<br>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<br>* Daily light therapy for 30 minutes for 8 weeks.<br>|
| No Intervention: Standard Care<br>Subjects will continue the care they routinely receive. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate |  | 8 weeks |