Feasibility of Adherence to Light Therapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Major Depression in Remission
• Intervention / Treatment: Device: Light therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T1Z3
      • UBC Mood Disorders Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• [1] Outpatients 19 to 65 years of age;
• [2] Diagnostic and Statistical Manual (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Light therapy; 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; Light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Rate	Rate of adherence (>75% of total daily sessions) to light therapy	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse Rate	Relapse as defined.	6 weeks
Change in Clinician-rated Depressive Symptoms	Changes in MADRS scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Montgomery-Asberg Depression Rating Scale. MADRS scores range from 0 to 60, with higher scores indicating greater severity of depression (worse outcome).	6 weeks
Change in Patient-rated Depressive Symptoms	Changes in scores from baseline to 6 weeks (or at relapse or early withdrawal) on the Quick Inventory of Depressive Symptomatology, Self-Rated scale (QIDS-SR). The QIDS-SR scores range from 0 to 27, with higher scores indicating greater severity of depression (worse outcome).	6 weeks
Discontinuation Symptoms	Scores on a discontinuation effects scale developed for this study, Antidepressant Discontinuation Symptoms Scale (ADSS). Scores range from 0 to 117, with higher scores indicating more severe discontinuation symptoms (worse outcome).	4 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Michael Smith Foundation for Health Research
• Investigators: Principal Investigator: Raymond W Lam, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: adherence; relapse prevention; major depressive disorder; light therapy
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: V2.0_May-17-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No