Efficacy of Daylight as Adjunctive Treatment in Patients With Depression

• ClinicalTrials.gov Identifier: NCT04712968
• Recruitment Status: Not yet recruiting
• First Posted: January 19, 2021
• Last Update Posted: March 4, 2021
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief Summary:

The aim of this study is to improve the treatment effect for outpatients with depression by adding regular daily morning daylight exposure to their treatment with antidepressants. Patients will wear a personal light tracker to keep them motivated. Our hypothesis is that patients daily exposed to morning daylight, as a supplement to standard treatment for depression, will achieve significantly higher antidepressant effect that patients receiving standard treatment alone. Furthermore, we hypothesize that they will experience improved well-being and sleep.

Condition or disease	Intervention/treatment	Phase
Unipolar Depression	Behavioral: Regular exposure to morning daylight	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Daylight as Adjunctive Treatment in Patients With Unipolar Depression
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 (intervention group); Regular exposure to morning daylight	Behavioral: Regular exposure to morning daylight; 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.
No Intervention: Group 2 (control group); Treatment as usual.

Outcome Measures

Primary Outcome Measures :

1. Change in depressive symptoms [ Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). ]
   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.
2. Change in depressive symptoms [ Time Frame: Participants will answer the questionnaire every fourth day in the 42 day studyperiod. ]
   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.
3. Change in sleep quality [ Time Frame: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint). ]
   Measured by Pittsburgh Sleeping Quality Index (PSQI).The score is between 0 and 21 "0" indicating no difficulty and "21" indicating severe difficulties.
4. Change in insomnia severity [ Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). ]
   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.
5. Change in well-being [ Time Frame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Mette Kragh, PhD; +45 23282815; mekrag@rm.dk

Sponsors and Collaborators

University of Aarhus

Investigators

• Principal Investigator: Mette Kragh, PhD; Department of Affective Disorders Arhus, University Hospital. Psychiatry

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04712968
• Other Study ID Numbers: Aarhus universitet
• First Posted: January 19, 2021
• Last Update Posted: March 4, 2021
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

Dayligt; Major Depression; Light Therapy; Sleep; Unipolar depression; Adjunctive treatment; Circadian rhythm

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders