Health TrialsbyHealthPanel

Virtual Reality Digital Therapeutics for Seasonal Affective Disorder

ConditionSeasonal Affective Disorder (SAD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnglia Ruskin University

About this trial

Seasonal Affective Disorder (SAD) is commonly treated with bright light therapy. Virtual reality (VR) is an immersive computer-generated environment, which has been used to treat mental health difficulties, such as depression, social anxiety and stress. This study aims to compare the use of VR with bright light therapy in treating SAD.

Participants will be randomly allocated to either the VR condition or the light box condition and instructed to use the respective device every day for 14 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

fluent in English and capable of giving informed consent

18 or older

resident in the United Kingdom and

able to access internet and attend Anglia Ruskin University's Cambridge campus

Disqualifiers

declared suffering from epilepsy (due to the risk that seizures may be triggered by VR use).

currently using photosensitizing medications or have significant retinal pathology, due to potentially detrimental effects of light box use. For other ophthalmologic conditions, consultation with an ophthalmologist will be recommended.

currently receiving active treatment for SAD, including antidepressant medication (less than 3 months), bright light treatment, or psychotherapy (e.g. CBT for seasonal affective disorder).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality (VR) Intervention

    Device

    10-min VR intervention, once a day, everyday for 14 days.

  • Light Box (LB) intervention

    Device

    30-min LB intervention once a day, everyday for 14 days.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Virtual reality (VR) interventionExperimental treatment 1 intervention
Group B: Light Box (LB) interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in levels of mood and depressive symptoms

Assessed by standardised psychological scales (Patient Health Questionnaire-9 (total score ranges from 0 to 27 with higher scores indication depression severity) and Positive and Negative Affect Schedule-Short Form (scores range from 10 to 50, with higher scores on the Positive Affect scale representing higher levels of positive affect, and higher scores on the Negative Affect scale representing higher levels of negative affect) and Visual Analogue Scales (0 to 100% with higher scores indicating better mood).

Time frame
From baseline (day 1 to 7) to follow-up (day 28) of treatment

Secondary outcomes

1

Participant engagement, experience and satisfaction of the intervention

Assessed by self-report survey including written qualitative feedback (short online feedback form focusing on ease of use, perceived benefits and disadvantages), usage data (e.g., session attendance, frequency, duration, completion time) dropout rates and adverse effects reported.

Time frame
From baseline (day 1 to 7) to end of follow-up (day 28) treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anglia Ruskin University

Lead sponsor

Reneural Technologies Ltd.

Collaborator

Aerial Icon Ltd.

Collaborator

Innovate UK, UKRI

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: