Virtual Reality Digital Therapeutics for Seasonal Affective Disorder

NCT07161570 | Not Yet Recruiting

• 1 other identifier: 10149188
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Seasonal Affective Disorder (SAD)

Keywords

SAD; VR

Outcome Measures

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).

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

Secondary Outcomes (1)

• Participant engagement, experience and satisfaction of the intervention

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

Study Arms (2)

Virtual reality (VR) intervention

EXPERIMENTAL

10-min VR intervention

Device: Virtual Reality (VR) Intervention

Light Box (LB) intervention

ACTIVE COMPARATOR

30-min LB intervention

Device: Light Box (LB) intervention

Interventions

Virtual Reality (VR) Intervention DEVICE

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

Virtual reality (VR) intervention

Light Box (LB) intervention DEVICE

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

Light Box (LB) intervention

Eligibility Criteria

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

You may qualify if:

• fluent in English and capable of giving informed consent
• or older
• resident in the United Kingdom and
• able to access internet and attend Anglia Ruskin University's Cambridge campus
• must self-identify or have been diagnosed with SAD, with moderate to severe symptoms

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Reneural Technologies Ltd.: collaborator
• Aerial Icon Ltd.: collaborator
• Innovate UK, UKRI: collaborator

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

Methods

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Debora Vasconcelos e Sa, PhD

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

• Jane Scott, PhD

  Anglia Ruskin University

  STUDY DIRECTOR

Central Study Contacts

Jane Scott, PhD

CONTACT

+44 1223698355; jane.scott@aru.ac.uk

Debora Vasconcelos e Sa, PhD

CONTACT

debora.sa@aru.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: October 27, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon study completion December 2026.
• Access Criteria: Findings from this study will be submitted for publication in peer-reviewed journals and anonymised findings will be included in an online data repository (e.g., Figshare; Open Science Foundation).