BLT: Bright Light Therapy as Augmentation of Depressive Symptoms on Acute Psychiatric Floor

Sponsor

State University of New York - Upstate Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04385394

Collaborator

(none)

100

Enrollment

Location

6.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to explore if Bright Light Therapy (BLT) as augmentation of depression treatment on an acute psychiatric floor is feasible, helps alleviate depressive symptoms, improve functioning, and decrease length of stay on the psychiatric floor.

Condition or Disease	Intervention/Treatment	Phase
Depression

Detailed Description

Background:

Bright light therapy is an evidence-based treatment for seasonal depression (SAD), recently there is evidence that it has some efficacy in nonseasonal major depressive disorder (MDD) when used together with antidepressants.

BLT works via the patient's eyes through

Melanopsin (Intrinsic Photo receptor ganglion Cells)
Suprachiasmatic Nucleus (SCN, master clock) which follows a rhythmic change
Serotonin

A number of studies showed seasonal changes in serotonergic parameters, including brain serotonin concentration and turnover. There were no research on using the BLT on the acute inpatient floor to augment the antidepressant treatment. Yet, there is a great need for such augmentation as for Selective Serotonin Reuptake Inhibitors (SSRI) to take full effect 4-6 weeks needed. Moreover, patients with depression often do not spend enough time on the direct sun light, which exacerbate and prolong their depressed mood. The augmentation with the BLT on the acute psychiatric floor will help the antidepressant work, expedite the recovery, and potentially shortens the length of stay in the hospital, which in turn will lead to an economic saving and faster return of the patient into the community and to the workforce.

Method:

This is an observational, case series study. All patients that meet exclusion criteria will have equal chance to receive BLT. We will administer the questionnaires before the BLT and at the end of treatment. Patient will continue to receive the pharmacological and therapeutic treatment on psychiatric floor as usual during the BLT. We will evaluate the changes in the questionnaires before and after BLT treatment, the length of stay on the unit. We will analyze the contributing factors such as age, gender, duration of depressive symptoms, other psychiatric and medical comorbidities, social factors (homelessness, social support, etc), current psychiatric medications.

Eligible patients will be invited to participate and consent will be obtain.

The type of light we use is the "Sun Box Sun Square +"
Emits about 10,000 lux of light and is wide enough to be used for more than 2 people.
186 watts
Full spectrum 5000k white light (without the UV)
It has an inbuilt spectrally transparent prismatic diffuser that blocks UV, that does not filter the quality of light and will not yellow.
Minimal heat and no bulb flutter.
Where: Bedroom / Common sitting area
Reading/ Having breakfast/ Watching tv/Drawing
Just after awakening within an hour early morning
30 mins/day
Must have eyes open, but not looking into the light
Staff will monitor while the patients are under the BLT

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Bright Light Therapy as Augmentation of Depressive Symptoms as Measured by Changes in Beck Depression Inventory, Hamilton Rating Scale for Depression and Outcome Questionnaire-45 on Acute Psychiatric Floor

Actual Study Start Date :

Jan 30, 2020

Actual Primary Completion Date :

Aug 20, 2020

Actual Study Completion Date :

Aug 20, 2020

Outcome Measures

Primary Outcome Measures

depression scores [7 days]
changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)
Functioning scores [7 days]
symptoms distress, interpersonal functioning, social role

Secondary Outcome Measures

length of stay [7 days]
duration of stay on an inpatient unit in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

depressive symptoms on BDI (score 14 and above - eligible for BLT) and/or
depressive symptoms on HAMD-17 (score 8 and above)

Exclusion Criteria:

no report of depressive symptoms; manic symptoms, acute psychosis, schizophrenia, schizoaffective disorder, impending Electro Convulsive Therapy (ECT), retinal risk factors, lupus, bright light sensitivity, glaucoma, cataracts, retinal detachment, retinopathy, patients on photosensitizing meds (tetracycline, sulfonamides, psoralens, and phenothiazine antipsychotics)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY Upstate Medical University	Syracuse	New York	United States	13210

Sponsors and Collaborators

State University of New York - Upstate Medical University

Investigators

Principal Investigator: Luba Leontieva, MD, PhD, State University of New York - Upstate Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT04385394

Other Study ID Numbers:

1507582-1

First Posted:

May 12, 2020

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Oct 28, 2021