search
Back to results

Cognitive Behavioral Therapy and Light Therapy

Primary Purpose

Pulmonary Hypertension, Insomnia, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
Bright Light Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy-Insomnia (CBT-I)

Bright Light Therapy

Standard Care

Arm Description

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.

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.

Subjects will continue the care they routinely receive.

Outcomes

Primary Outcome Measures

Retention Rate

Secondary Outcome Measures

Full Information

First Posted
April 13, 2022
Last Updated
January 19, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT05337943
Brief Title
Cognitive Behavioral Therapy and Light Therapy
Official Title
Feasibility of Cognitive Behavioral Therapy vs. Bright Light Therapy to Treat Insomnia and Fatigue: an RCT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Insomnia, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy-Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bright Light Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Subjects will continue the care they routinely receive.
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Intervention Description
Weekly sessions with a therapist to improve sleep for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Bright Light Therapy
Intervention Description
Daily light therapy for 30 minutes for 8 weeks.
Primary Outcome Measure Information:
Title
Retention Rate
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lea Ann A Matura, PhD
Phone
2157468819
Email
matura@nursing.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lea Ann A Matura, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lea Ann A Matura, PhD
Phone
215-898-8283
Email
matura@nursing.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Behavioral Therapy and Light Therapy

We'll reach out to this number within 24 hrs