NCT02800850

Brief Summary

Many older adults with dementia living in long-term care facilities experience depression and agitation, which cause angst and personal suffering. Prior to this research, evidence was inconclusive but indicated that bright light exposure may reduce depression and agitation in long-term care residents with dementia. The purpose of this study was to determine if the degree of improvement in depression and agitation scores over the course of eight weeks was significantly greater in persons with dementia receiving bright light exposure than in persons with dementia receiving placebo light exposure. Sixty individuals participated in the study, with 30 in the bright light group and 30 in the low level light group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

May 31, 2016

Last Update Submit

June 16, 2016

Conditions

Dementia

Keywords

DementiaDepressionAgitationBright Light

Outcome Measures

Primary Outcomes (2)

  • Depressive Symptom Assessment for Older Adults

    After the eight-week experiment

  • Cohen-Mansfield Agitation Inventory (Frequency)

    After the eight-week experiment

Study Arms (2)

Bright Light Group

EXPERIMENTAL

Bright Light Exposure

Behavioral: Bright Light

Control Group

PLACEBO COMPARATOR

Placebo Light Exposure

Behavioral: Placebo Light

Interventions

Bright LightBEHAVIORAL
Bright Light Group
Placebo LightBEHAVIORAL
Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Onega LL, Pierce TW, Epperly L. Effect of Bright Light Exposure on Depression and Agitation in Older Adults with Dementia. Issues Ment Health Nurs. 2016 Sep;37(9):660-667. doi: 10.1080/01612840.2016.1183736. Epub 2016 Jun 2.

    PMID: 27254531RESULT

MeSH Terms

Conditions

DementiaDepressionPsychomotor Agitation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in Dementia

Study Officials

  • Lisa L Onega, PhD, RN, MBA

    Radford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 15, 2016

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share