Feasibility of Adherence to Light Therapy

NCT04944758 | Terminated Results

• 1 other identifier: V2.0_May-17-2021
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression in Remission

Keywords

major depressive disorder; light therapy; relapse prevention; adherence

Outcome Measures

Primary Outcomes (1)

• Adherence Rate

  Rate of adherence (\>75% of total daily sessions) to light therapy

  6 weeks

Secondary Outcomes (4)

• Relapse Rate

  6 weeks

• Change in Clinician-rated Depressive Symptoms

  6 weeks

• Change in Patient-rated Depressive Symptoms

  6 weeks

• Discontinuation Symptoms

  4 weeks

Study Arms (1)

Light therapy

OTHER

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

Interventions

Light therapy DEVICE

Light therapy

Light therapy

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[1\] 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.

You may not qualify if:

• \[1\] 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

UBC Mood Disorders Centre

Vancouver, British Columbia, V6T1Z3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Raymond Lam
• Organization: University of British Columbia

r.lam@ubc.ca

6048227325

Study Officials

• Raymond W Lam, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open-label feasibility study

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 30, 2021
• Study Start: April 21, 2022
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)