- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712968
Efficacy of Daylight as Adjunctive Treatment in Patients With Depression
Efficacy of Daylight as Adjunctive Treatment in Patients With Unipolar Depression - a Randomized Controlled Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Due to inadequate efficiency of existing medical and psychotherapeutic treatments for depression there is a need for investigating the efficacy of adjunctive treatments. Light therapy has proven efficient as an add-on treatment for depression, but some patients might prefer being outdoors rather than sitting in front of a light therapy screen. However, no high-quality studies, have so far investigated the antidepressant and other potential positive effects of regular exposure to morning daylight for patients with unipolar depression.
The aim of this study is to examine the efficacy of morning daylight as add-on to treatment as usual in patients with depression. Efficacy is measured as reduction of depressive symptoms, improvement of sleep quality, and improvement of well-being.
Methods and material: A randomized controlled trial comprising 150 patients diagnosed with unipolar depression aged 18-50 years will be conducted. Patients are included after giving informed consent and the study period is 6 weeks. A wearable Personal Light Tracker, measuring the amount off light received, will be provided for all participants. Participants will be randomized into the following groups:
Group 1: Daylight (outdoor daylight exposed stay for minimum 30 minutes per day before 1 pm). To motivate patients to go outside they will receive psychoeducation on the connection between exposure to morning daylight and a possible antidepressant effect, and they are introduced to potential options for outdoor activities. A detailed instruction to the personal light tracker and the matching app, for monitoring the amount of light received throughout the day, is provided.
Group 2: Control group receiving treatment as usual. Patients will wear a personal light tracker but they are not introduced to the light-monitoring-app.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus, Denmark
- "Psykiatriens Hus" Department of Affective Disorders Arhus, University Hospital. Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fulfilling criteria for an ICD-10 diagnosis of unipolar depression (F. 32.0, F.32.1, F.32.2, F32.3, F. 32.8. F.33.0, F.33.1, F.33.2, F. 33.3)
- Hamilton Depression Score (HAM-D17) ≥ 12
- In treatment with the same antidepressant medication 14 days prior to inclusion
- The participant must have access to a smart phone
Exclusion Criteria:
- Actual treatment with Electro Convulsive Therapy (ECT)
- Seasonal Affective Disorder (SAD)
- Known sleep disturbances (sleep-apnoea, narcolepsy, or "restless legs syndrome")
- On lithium, agomelatine, melatonin and/or mirtazapine
- Known eye disorders
- Current alcohol- or drug abuse
- Current user of Light therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1 (intervention group)
Regular exposure to morning daylight
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Participants are asked to stay outside in morning daylight for minimum 30 minutes each day before 1 pm for 6 weeks.
A specific plan for individual outdoor possibilities for daylight exposure is made (e.g. a walk, a stay in a park or in their garden, a bike trip).
Furthermore a detailed instruction to the personal light tracker "LYS Button" and the matching "LYS Insight app" is provided.
The "LYS Insight app" gives the user access to real-time insight of light stimulus.
Further, the participants receive psycho-education on the connection between exposure to morning daylight and antidepressant effect.
All participants in this group receive the intervention as add-on to usual treatment, which may comprise prescribed antidepressants, psychotherapy, including psycho-education and psychiatric care.
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No Intervention: Group 2 (control group)
Treatment as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms
Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Measured on the Hamilton Depression Rating Scale interviewbased 17 item version (HAM-D17).The scale ranges from 0 to 52; the higher the score the more depressed is the patient.
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Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Change in depressive symptoms
Time Frame: Participants will answer the questionnaire every fourth day in the 42 day studyperiod.
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Measured on Hamilton Depression Scale: selfreported version (HAM-D6).
A questionnaire measuring depressive symptoms.
The scale ranges from 0-22, the higher the score the more depressed is the patient.
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Participants will answer the questionnaire every fourth day in the 42 day studyperiod.
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Change in sleep quality
Time Frame: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
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Measured by Pittsburgh Sleeping Quality Index (PSQI).The score is between 0 and 21 "0" indicating no difficulty and "21" indicating severe difficulties.
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Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
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Change in insomnia severity
Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Measured by Insomnia Severity Index (ISI).
Self-report instrument measuring the patient's perception of insomnia.
The scale ranges from 0 to 28.
The higher the score the more severe insomnia.
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Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Change in well-being
Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Measured on The WHO-5 Well-Being Index (WHO-5).
A questionnaire which measures well-being.
The scale ranges from 0 to 100, the higher the score the more well-being.
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Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mette Kragh, PhD, Department of Affective Disorders Arhus, University Hospital. Psychiatry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aarhus universitet
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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