Depression Mental and Behavioural Disorders
Conditions
Interventions
Stratification
Participants will be assigned to either an intervention or control condition. Stratification will be based on current psychoactive drug treatment (none vs medication) and their baseline
17–27: moderate to severe). Participants will be unaware that two different conditions exist, and testing researchers will be blinded to participants’ group allocation. Stratification will be done thr
the testing researchers are blinded to which session names belong to which condition.
Participants’ IDs, assigned stroboscopic session names, and conditions are saved to a file and will be periodicall
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Depression Patient Health Questionnaire-9 (PHQ-9) score of 4-27, reflecting mild to severe depression 2. >18 years of age 3. Willingness to take part in the study protocol
Exclusion criteria
Exclusion criteria: 1. Positive response to any question on the safety screening protocol (see attached) 2. PHQ-9 scores are below the thresholds indicative of any severity of depression (score of <5) 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 10. Regular use of light therapy, including the use of light boxes, light visors and dawn simulation lamps (does not include the use of seasonal affective disorder [SAD] alarm clocks) 10. Depressive symptomology that displays a seasonal pattern
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. This information will be collected throughout the study. 2. Tolerability measured on a 10-point scale, ranging from no discomfort (0) to severe discomfort (10) after each 30-minute strobe session, assessing each 30-second section. Outcome: Mean tolerability scores 35. Calculated following the completion of the study. 4. Recruitment: Recruited participants are defined as those who attended at least one session. Retained participants are those who completed all stroboscopic testing sessions. Outcome: Recruit 84 participants within 18 months (=80% recruitment rate acceptable) and retain at least 80% of those recruited at treatment completion at 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory analyses will examine the trajectories of affective symptom measures across the study period, from baseline (pre-session 1) to either post-session 4 or the week 5 follow-up, depending on the instrument: 1. Overall depressive symptom severity measured using the Patient Health Questionnaire-9 (PHQ-9), total score (0–27) 2. Sadness (depressed mood), anhedonia (loss of pleasure), and overall energy (psychomotor activity) measured using the Maudsley 3-item Visual Analogue Scale (M3VAS), each measured on a scale from 0-100. 3. The frequency of a broad range of Positive (SPANE-P, 6–30) and Negative Experiences (SPANE-N, 6–30) measured using the Scale of Positive and Negative Experience (SPANE) 4. Depressive symptom severity measured using the Beck Depression Inventory-II (BDI-II), total score (0–63) 5. Depressive symptom severity measured using the Montgomery–Åsberg Depression Rating Scale – Self-Report (MADRS-S), total score (0–54) for self-reported depressive symptoms 6. Anxiety severity measured using the Beck Anxiety Inventory (BAI), total score (0–63) 7. Treatment expectations measured using a combination of the Treatment Expectation Questionnaire (TEX-Q) and the Stanford Expectations of Treatment Scale (SETS) 8. Participants' overall experiences during each stroboscopic session measured using the Six-Dimensional Visual Hallucination Questionnaire (6D-VHQ) following each stroboscopic session 9. Participants' visual experiences during each stroboscopic session measured using the 11-factor Altered States of Consciousness rating scale (11-ASC) | — |
Countries
England, United Kingdom
Contacts
Public ContactDavid Schwartzman
Outcome results
None listed