Feasibility of Adherence to Light Therapy

Study Overview
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Brief Summary
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In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.

Detailed Description
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Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment. Light therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question. Before conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.

Official Title
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A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder

Conditions
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Major Depression in Remission

Intervention / Treatment
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* Device: Light therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [1] Outpatients 19 to 65 years of age; [2] DSM-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview; [3] taking an antidepressant for no more than six months; [4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons; [5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS]; [6] Willing and able to complete self-report and online assessments including sufficient fluency in English. Exclusion Criteria: [1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime); [2] MDD with psychotic features (lifetime); [3] significant personality disorder diagnosis [e.g., borderline, antisocial]; [4] High suicidal risk, defined by clinician judgment; [5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening; [6] Significant neurological disorders, head trauma, or other unstable medical conditions; [7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers); [8] history of severe withdrawal effects with antidepressant discontinuation; [9] retinal disease or other eye condition preventing use of bright light therapy; [10] use of photosensitizing medication within 1 week of baseline visit.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Light therapy<br>Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication. | Device: Light therapy<br>* Light therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Rate of adherence (>75% of total daily sessions) to light therapy | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate | Relapse will be defined as any of the following: [1] MADRS total score ≥22 for at least 2 consecutive weeks. If the relapse criterion of MADRS total score ≥22 is met at a scheduled assessment visit or an unscheduled relapse-assessment visit, an additional visit (i.e., the relapse-verification visit) will be scheduled within 1 to 2 weeks to verify the relapse; [2] Hospitalization for worsening of depression; [3] Suicidal ideation with intent, or suicidal behavior; [4] Any change in treatment (e.g., starting an antidepressant). | 12 weeks | 
| Change in clinician-rated depressive symptoms | Changes in scores from baseline to 12 weeks on the Montgomery-Asberg Depression Rating Scale. | 12 weeks | 
| Change in patient-rated depressive symptoms | Changes in scores from baseline to 12 weeks on the Quick Inventory of Depressive Symptomatology, Self-Rated scale. | 12 weeks | 
| Discontinuation symptoms | Scores on a discontinuation effects scale developed for this study. | 4, 8, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depressive disorder, light therapy, relapse prevention, adherence