Efficacy of Daylight as Adjunctive Treatment in Patients With Depression

NCT04712968 | Terminated

• 1 other identifier: Aarhus universitet
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in depressive symptoms

  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.

  Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

• Change in depressive symptoms

  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.

  Participants will answer the questionnaire every fourth day in the 42 day studyperiod.

• Change in sleep quality

  Measured by Pittsburgh Sleeping Quality Index (PSQI).The score is between 0 and 21 "0" indicating no difficulty and "21" indicating severe difficulties.

  Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).

• Change in insomnia severity

  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.

  Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

• Change in well-being

  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.

  Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

Study Arms (2)

Group 1 (intervention group)

EXPERIMENTAL

Regular exposure to morning daylight

Behavioral: Regular exposure to morning daylight

Group 2 (control group)

NO INTERVENTION

Treatment as usual.

Interventions

Regular exposure to morning daylight BEHAVIORAL

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.

Group 1 (intervention group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• The participant must have access to a smart phone

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

"Psykiatriens Hus" Department of Affective Disorders Arhus, University Hospital. Psychiatry

Aarhus, Denmark

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Mette Kragh, PhD

  Department of Affective Disorders Arhus, University Hospital. Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2021-09

Locations

DK (1)