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

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

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.

Study Overview

Status

Completed

Conditions

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

  1. Melanopsin (Intrinsic Photo receptor ganglion Cells)
  2. Suprachiasmatic Nucleus (SCN, master clock) which follows a rhythmic change
  3. 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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

inpatients reporting depressive symptoms that meet inclusion criteria

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression scores
Time Frame: 7 days
changes in depression scores, administered before light therapy and prior to discharge (corresponds to the last session of light therapy)
7 days
Functioning scores
Time Frame: 7 days
symptoms distress, interpersonal functioning, social role
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay
Time Frame: 7 days
duration of stay on an inpatient unit in days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2020

Primary Completion (ACTUAL)

August 20, 2020

Study Completion (ACTUAL)

August 20, 2020

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1507582-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

3
Subscribe