Depression Mental and Behavioural Disorders
Conditions
Interventions
This tolerability study will not have a control condition.
Participants will complete an online safety questionnaire for pre-screening to minimise the risk of seizures from strobe light and screen f
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. Willingness to take part in the study 3. PHQ-9 score indicative of mild to severe depression (score of 5-27)
Exclusion criteria
Exclusion criteria: 1. Positive response to any question on the safety screening protocol (see attached) 2. PHQ-9 scores are above the thresholds indicative of mild depression (score of 5-27) 5. Currently pregnant 6. History of or current substance or drug abuse 7. History of or current diagnosis of psychosis; bipolar disorder; Parkinson's Disease; dementia; Alzheimer's disease 8. A history of traumatic brain injury (TBI) 9. Presence of certain eye disorders such as retinal blindness, cataracts, retinal diseases of the eye and glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety, defined as no severe adverse reactions as a direct result of stroboscopic stimulation, defined as a reaction that results in death, is life-threatening or requires hospitalisation. 2. Tolerability measured on a 10-point scale ranging from no discomfort (0) to severe discomfort (10) after each 2-minute strobe session, assessing each 30-second section. Outcome: Identify a range of stroboscopic parameter settings with an upper 80% confidence limit of the mean tolerability score is <7 (mild to moderate) across all minor side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Type and frequency of side effects measured using the Visual Discomfort Questionnaire after each 2-minute strobe session 2. Feasibility estimated through participant recruitment numbers over the duration of the study 3. Arousal, enjoyment, overall discomfort and engagement as reported through single visual analogue scale items (scale 0-100) following each 2-minute strobe session | — |
Countries
England, United Kingdom
Contacts
Public ContactDavid Schwartzman
Outcome results
None listed