Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000529549
Ethics application status
Not yet submitted
Date submitted
8/05/2015
Date registered
27/05/2015
Date last updated
27/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Light Therapy and Depression in Residential Aged-Care Clients: A Treatment Approach
Scientific title
In elderly residents with depression in dementia, is artificial light therapy effective in reducing their depressive symptoms, as compared with natural light therapy?
Secondary ID [1] 286663 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
 294997 0
Condition category
Condition code
Mental Health 295262 295262 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Group A will receive Artificial light therapy: provided through Re-Timer goggles, which provide a blue-green 500 nm dominant wavelength, UV free-light at a setting of 506 Lux lm/m2. Participants will wear the goggles and receive the light therapy between the hours of 6am and 8am for 30 minutes for two consecutive weeks, Monday to Friday. Researchers will remain with participants to monitor adherence.

Arm 2: Group B will receive Natural light therapy: provided through natural sunlight. Participants will sit outside in the early morning light for 30 minutes between the hours of 6am and 8am, for two consecutive weeks, Monday to Friday. Researchers will remain with participants to monitor adherence.


Group A and B will be randomly assigned to A1 or A2 and B1 or B2. A1 (artificial light) and B1 (natural light) will receive therapy for two consecutive weeks, Monday to Friday. While Group A2 and B2 will be allocated to the control group and receive care as usual. Following these two weeks, Group A2 (artificial light) and B2 (natural light) will receive two consecutive weeks of light therapy and A1 and B2 will receive care as usual. Following this four week period, all participants will be allocated to a "wash out" period of two consecutive weeks. The total study time is 6 weeks. Participants will either receive artificial light therapy or natural light therapy. Outcome measures will be administered at baseline, 2 weeks following treatment commencement, 4 weeks following treatment commencement and 6 weeks following treatment commencement.
Intervention code [1] 291809 0
Treatment: Devices
Intervention code [2] 291933 0
Treatment: Other
Comparator / control treatment
When participants from Arm 1 and Arm 2 are not receiving light therapy they will be receiving no treatment wait-list group and be receiving care as usual for two consecutive weeks. Care as usual includes day to day care received at the residential aged-care facility, including physiotherapy, podiatry and dietician. All participants may receive different day to day care within the facility. This is not expected to significantly alter the study outcomes. Control participants will receive treatment when those first assigned to the intervention group have completed their treatment i.e. after 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 295009 0
Mean score for the Cornell Scale for Depression in Dementia self-reported version and caregiver version
Timepoint [1] 295009 0
At baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement and 6 weeks after treatment commencement
Secondary outcome [1] 314576 0
sleep characteristics as measured by a sleep diary and actiwatch 2. The sleep diary gathers information on time participant went to bed, estimated time of sleep onset, amount of awakenings during the night, time of wake onset and amount of naps taken each day. The actiwatch 2 is a monitoring system that measures participants sleep/wake pattern and activity in response to therapy.
Timepoint [1] 314576 0
Continuously measured for 6 weeks, from baseline to study cessation.

Eligibility
Key inclusion criteria
A score of 6 or higher on the Cornell Scale for Depression in Dementia
Meet the criteria for dementia as set out by the Diagnostic and Statistical Manual IV
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Arm 1: Artifical light therapy
No history of epilepsy or manic depressive psychosis
No diagnosis of bipolar disorder
No photosensitizing medication including but not limited to, pain killers or psychiatric drugs
No degenerative eye conditions including but not limited to, cataracts, glaucoma or retinal disorders

Arm 2: Natural light therapy
No photosensitizing medication including but not limited to, pain killers or psychiatric drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple allocation using coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Group A and B will be randomly assigned to A1 or A2 and B1 or B2. A1 (artificial light) and B1 (natural light) will receive therapy for two consecutive weeks, Monday to Friday. While Group A2 and B2 will be allocated to the control group and receive care as usual. Following these two weeks, Group A2 (artificial light) and B2 (natural light) will receive two consecutive weeks of light therapy and A1 and B2 will receive care as usual. Following this four week period, all participants will be allocated to a "wash out" period of two consecutive weeks. The total study time is 6 weeks. Participants will either receive artificial light therapy or natural light therapy. Outcome measures will be administered at baseline, 2 weeks following treatment commencement, 4 weeks following treatment commencement and 6 weeks following treatment commencement.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics suitable for a small-n design. The statistics will illustrate means and standard deviations and will be presented using bar graphs. G*Power was originally used to determine the necessary sample size. However, the stringent inclusion and exclusion criteria will likely lead to a small number of suitable participants receiving artificial light therapy. The study will act as a pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291273 0
Other
Name [1] 291273 0
individual funding - Miss Natalie Muldoon
Country [1] 291273 0
Australia
Primary sponsor type
Individual
Name
Miss Natalie Muldoon
Address
Australia Central Queensland University, Bruce Highway, North Rockhampton QLD 4702
Country
Australia
Secondary sponsor category [1] 289916 0
None
Name [1] 289916 0
Address [1] 289916 0
Country [1] 289916 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292798 0
CQUniversity's Human Research Ethics Committee (EC00158)
Ethics committee address [1] 292798 0
Ethics committee country [1] 292798 0
Australia
Date submitted for ethics approval [1] 292798 0
12/05/2015
Approval date [1] 292798 0
Ethics approval number [1] 292798 0
H15/04-066

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57098 0
Prof Lynne Parkinson
Address 57098 0
CQUniversity
Building 32,
Bruce Highway
Rockhampton
QLD, 4702
Country 57098 0
Australia
Phone 57098 0
+61 (0) 7 4930 6448
Fax 57098 0
Email 57098 0
[email protected]
Contact person for public queries
Name 57099 0
Natalie Muldoon
Address 57099 0
Miss Natalie Muldoon
Central Queensland University,
Bruce Highway, North Rockhampton QLD 4702
Country 57099 0
Australia
Phone 57099 0
+61 404625099
Fax 57099 0
Email 57099 0
[email protected]
Contact person for scientific queries
Name 57100 0
Natalie Muldoon
Address 57100 0
Miss Natalie Muldoon
Central Queensland University,
Bruce Highway, North Rockhampton QLD 4702
Country 57100 0
Australia
Phone 57100 0
+61 404625099
Fax 57100 0
Email 57100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.