Feasibility of Adherence to Light Therapy

NCT ID: NCT04944758

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2022-06-21

Brief Summary

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

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.

Conditions

Major Depression in Remission

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Light therapy

Intervention Type: DEVICE

Light therapy

Interventions

Light therapy

Light therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Smith Foundation for Health Research

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Raymond Lam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond W Lam, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

UBC Mood Disorders Centre

Vancouver, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V2.0_May-17-2021

Identifier Type: -

Identifier Source: org_study_id