Mild - moderate depression Mental and Behavioural Disorders Depression
Conditions
Interventions
Active group: Standard light box device administering 10,000lux white light - to be used 30 minutes in the morning, within ten minutes of waking before midday.
Control group: Altered
Sponsors
University of Kent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 64 years old 2. Current diagnosis of mild-moderate depression defined via a PHQ-9 score of 5 to 14 3. Ability to provide informed consent for randomisation, treatment and follow up, including a good command of the English language 4. Ability to access their general practice surgery / University campus at Medway for assessment
Exclusion criteria
Exclusion criteria: 1. Pregnant/planning pregnancy or breastfeeding 2. Alterations to participant antidepressant treatment, including medication and counselling/talk therapy, in the previous four weeks of trial commencement or during the trial 3. Current treatment with antipsychotic drugs 4. Previous use of light therapy, including use of light boxes, light visors and dawn simulation lamps. This does not include the use of seasonal affective disorder (SAD) alarm clocks 5. History of or current substance/drug abuse 6. History or current diagnosis of; psychosis, severe depression, bipolar disorder, Parkinson’s, dementia or Alzheimer’s disease. 7. A history of light-induced migraine or epilepsy 8. A history of traumatic brain injury (TBI) 9. Presence of ocular disorders including retinal blindness, cataract, retinal diseases of the eye and glaucoma. 10. Current oral diseases, such as candidiasis, or inflammation or lesions within the mouth 11. Is currently or has recently been involved in any research prior to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment at four weeks of the intervention as compared to baseline, measured by the Structured Interview Guide for the Hamilton Depression Rating Scale – Seasonal Affective Disorder version Self-rated (SIGH-SAD-SR). The resulting SIGH-SAD score will be treated in two ways. A total SIGH-SAD-SR score of less than or equal to 50% of the baseline total score will be used to define “response”. A total SIGH-SAD-SR score less than or equal to 50% of the baseline total score, and a total score of less than or equal to 8 will be used to define “remission”. These parameters provide a quantitative measurement of improvement and estimate participant recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response to intervention defined by a change in depression score as measured by the Patient Health Questionnaire 9 (PHQ-9), an established primary care depression assessment tool. This measurement will be used to investigate the suitability of this questionnaire to measure response of a patient using light therapy in primary care, by comparing with SIGH-SAD-SR scores which are collected concurrently. 2. Measurement and comparison of total weekly SIGH-SAD-SR scores of the active and control intervention arms, collected from weeks 1 to 4 of the trial, as compared to baseline SIGH-SAD-SR score. 3. To investigate the relationship between the global seasonality score (GSS), collected for each participant at baseline by the SPAQ, and the difference between the total SIGH-SAD-SR score measured at baseline and after 4 weeks of the intervention. 4. Comparison of the phase angle between time to peak of cortisol concentration and dim-light melatonin onset (DLMO), between participants who responded and did not respond to active light therapy intervention. DMLO will be determined through analysis of the evening saliva samples. It is defined as the interpolated clock time at which melatonin concentration reaches 20pg/ml. 5. Compare active and control intervention groups’ behavioural activity profiles (actigraphy) by analysing duration of sleep, sleep efficiency (percentage of actual sleep between sleep onset and final awakening) and sleep onset latency in response to intervention, and one week post-intervention. 6. The feasibility of using light therapy in patients own homes will be evaluated using the adherence data gathered by Actiwatch data, participant diary entries, and post-trial semi-structured interviews. The relationship between self-efficacy and social support, two factors which have shown to be potential key determinants of adherence to light therapy in a previous study (Roecklein et al | — |
Countries
England, United Kingdom
Outcome results
None listed