Clinical trial NCT04944758: Feasibility of Adherence to Light Therapy
Official title: A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depression in Remission
Keywords: major depressive disorder
light therapy
relapse prevention
adherence
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Michael Smith Foundation for Health Research
First posted: 2021-06-30
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label feasibility study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Adherence Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Relapse Rate
timeFrame: 6 weeks
measure: Change in Clinician-rated Depressive Symptoms
timeFrame: 6 weeks
measure: Change in Patient-rated Depressive Symptoms
timeFrame: 6 weeks
measure: Discontinuation Symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Mood Disorders Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Raymond W Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: