Cystic FibrosisNCT04921332
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
A study testing Bright Light Therapy (BLT) Lamp in people with Cystic Fibrosis and Depressive Symptoms, run by Erica Osborn at 2 sites in United States.
Trial summary
This is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with CF and COPD. The purpose of this project is to apply a daily 30-minute BLT intervention to hospitalized adult CF and COPD patients in order to decrease symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Depressive Symptoms, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bright Light Therapy (BLT) Lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2021to 22 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cystic fibrosis or chronic obstructive pulmonary disease (COPD)
- Adult age 18 or older
- Admitted to the pulmonary step-down and transplant unit
- Score greater than zero on pre-intervention Beck's Depression Inventory-II (BDI-II)
Who cannot join
- Pre-existing ophthalmological conditions or photosensitivity
- Migraines
- Receiving high dose steroids for transplant rejection (due to mood altering qualities),
- Antibiotics that increase light sensitivity
- Diagnosed with bipolar disorder (light therapy may trigger mania)
- Admissions anticipated to span less than 48 hours
- Children are being excluded due to the fact that only adult CF and COPD subjects are admitted to University of Pittsburgh Medical Center (UPMC) Presbyterian hospital
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients With Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)
This is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with CF and COPD. The purpose of this project is to apply a daily 30-minute BLT intervention to hospitalized adult CF and COPD patients in order to decrease symptoms of depression as measured by depression inventory scoring.
Read the detailed description
This project will occur on a 29-bed pulmonary step-down unit at a 1,600-bed academic medical center. This unit commonly treats patients with CF, COPD, and other pulmonary complications. The unit's patient care staff will be educated on the bright light lamps in order to prevent interruptions and to encourage compliance.
- Being tested
- Bright Light Therapy (BLT) Lamp
- Keywords
- cystic fibrosis, depression, bright light therapy, adult, copd
- Medical subject headings
- Cystic Fibrosis, Depression, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light Therapy (BLT) LampDevice
Also called Verilux HappyLight Luxe - UV-Free LED Therapy Lamp by Verilux
With its built in automatic timer shut-off function, the bedside registered nurse (RN) would not need to return to the room to turn off this lamp after 30 minutes because the lamp will automatically shut off on its own.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy (BLT) | Experimental | The intervention will consist of daily BLT sessions lasting 30 minutes at approximately 10AM (since many CF and COPD patients may not awaken until this time) starting on the day of admission through discharge for a goal of seven consecutive days. The intervention will use a 10,000-lux light box placed approximately 16-24 inches from the patient's face. Receives: Device: Bright Light Therapy (BLT) Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II)
Change between pre-intervention and post-intervention self-reported answer totals to the 21 scored items on BDI-II (minimum score obtainable=0 (absent symptoms); maximum score obtainable=63 (most severe symptoms).
Measured: First at time of admission, second at end of 7 day goal or upon discharge.
Secondary outcomes (1)
Number of Days Until Completion of Daily Bright Light Therapy (BLT)
The RN will sign a daily log indicating what time therapy was initiated and if therapy was refused. These logs will be collected from patient doors at the end of each week by the principal investigator (PI) in order to measure compliance with completion of therapy on a daily basis.
Measured: Daily for duration of intervention period (goal/maximum of 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start7 Sep 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Why it stopped: Study was stopped secondary to principal investigator needing to analyze data and present prior to graduating. Target enrollment not able to be reached prior to this.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a non-randomized, single group, pre- and post-intervention project.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erica Osborn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erica Osborn, University of Pittsburgh
- Investigators
- Erica Osborn, BSN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921332
- Sponsor's protocol ID
- STUDY20110407
- Status last verified
- Feb 2023
- First submitted
- 2 Jun 2021
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data produced from this project may be shared with investigators conducting research on a similar topic within the University of Pittsburgh and outside. Shared information from this project will be de-identified under an approved DUA.
Publications
Kopp BT, Hayes D Jr, Ghera P, Patel A, Kirkby S, Kowatch RA, Splaingard M. Pilot trial of light therapy for depression in hospitalized patients with cystic fibrosis. J Affect Disord. 2016 Jan 1;189:164-8. doi: 10.1016/j.jad.2015.08.056. Epub 2015 Sep 28.
PubMed 26433764Guzel Ozdemir P, Boysan M, Smolensky MH, Selvi Y, Aydin A, Yilmaz E. Comparison of venlafaxine alone versus venlafaxine plus bright light therapy combination for severe major depressive disorder. J Clin Psychiatry. 2015 May;76(5):e645-54. doi: 10.4088/JCP.14m09376.
PubMed 26035199Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
PubMed 26580307
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bright Light Therapy on Depression Symptoms in Adult Inpatients With Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04921332
- Acronym / sponsor ID
- STUDY20110407
- Keywords
- cystic fibrosis, depression, bright light therapy, adult, copd
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped secondary to principal investigator needing to analyze data and present prior to graduating. Target enrollment not able to be reached prior to this.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Erica OsbornUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with CF and COPD. The purpose of this project is to apply a daily 30-minute BLT intervention to hospitalized adult CF and COPD patients in order to decrease symptoms of depression as measured by depression inventory scoring.
Detailed description
This project will occur on a 29-bed pulmonary step-down unit at a 1,600-bed academic medical center. This unit commonly treats patients with CF, COPD, and other pulmonary complications. The unit's patient care staff will be educated on the bright light lamps in order to prevent interruptions and to encourage compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized, single group, pre- and post-intervention project.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy (BLT) | Experimental | Device: Bright Light Therapy (BLT) LampThe intervention will consist of daily BLT sessions lasting 30 minutes at approximately 10AM (since many CF and COPD patients may not awaken until this time) starting on the day of admission through discharge for a goal of seven consecutive days. The intervention will use a 10,000-lux light box placed approximately 16-24 inches from the patient's face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with cystic fibrosis or chronic obstructive pulmonary disease (COPD)
- Adult age 18 or older
- Admitted to the pulmonary step-down and transplant unit
- Score greater than zero on pre-intervention Beck's Depression Inventory-II (BDI-II)
Key exclusion criteria (7 listed)
- Pre-existing ophthalmological conditions or photosensitivity
- Migraines
- Receiving high dose steroids for transplant rejection (due to mood altering qualities),
- Antibiotics that increase light sensitivity
- Diagnosed with bipolar disorder (light therapy may trigger mania)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light Therapy (BLT) LampAlso: Verilux HappyLight Luxe - UV-Free LED Therapy Lamp by VeriluxWith its built in automatic timer shut-off function, the bedside registered nurse (RN) would not need to return to the room to turn off this lamp after 30 minutes because the lamp will automatically shut off on its own. | Device | Bright Light Therapy (BLT) |
Primary outcome
Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II)
Time frame: First at time of admission, second at end of 7 day goal or upon discharge.
Change between pre-intervention and post-intervention self-reported answer totals to the 21 scored items on BDI-II (minimum score obtainable=0 (absent symptoms); maximum score obtainable=63 (most severe symptoms).
1 secondary outcome
Number of Days Until Completion of Daily Bright Light Therapy (BLT)
Time frame: Daily for duration of intervention period (goal/maximum of 7 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26433764Kopp BT, Hayes D Jr, Ghera P, Patel A, Kirkby S, Kowatch RA, Splaingard M. Pilot trial of light therapy for depression in hospitalized patients with cystic fibrosis. J Affect Disord. 2016 Jan 1;189:164-8. doi: 10.1016/j.jad.2015.08.056. Epub 2015 Sep 28.
- Background: PubMed 26035199Guzel Ozdemir P, Boysan M, Smolensky MH, Selvi Y, Aydin A, Yilmaz E. Comparison of venlafaxine alone versus venlafaxine plus bright light therapy combination for severe major depressive disorder. J Clin Psychiatry. 2015 May;76(5):e645-54. doi: 10.4088/JCP.14m09376.
- Background: PubMed 26580307Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
- Individual participant dataSharing planned: Yes. Data produced from this project may be shared with investigators conducting research on a similar topic within the University of Pittsburgh and outside. Shared information from this project will be de-identified under an approved DUA.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Osborn, BSN principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy (BLT) Lamp in people with Cystic Fibrosis and Depressive Symptoms, run by Erica Osborn at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pre- and Post-intervention Beck's Depression Inventory II Scores (BDI-II) (time frame: First at time of admission, second at end of 7 day goal or upon discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.