Virtual Reality Digital Therapeutics for Seasonal Affective Disorder (VR-SAD)

September 4, 2025 updated by: Debora de Vasconcelos e Sa, Anglia Ruskin University

Effectiveness of Virtual Reality Digital Therapeutics for Seasonal Affective Disorder.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Seasonal Affective Disorder (SAD) affects approximately 1 in 20 people in the UK during the winter months, with significant impacts on wellbeing and productivity. SAD is commonly treated with bright light treatment, alone or in combination with psychological therapy or antidepressants. Virtual reality (VR) is an immersive computer-generated environment. VR technology has been applied to treat a range of mental health conditions, including depression, anxiety, and stress. However, the possible contribution of this technology to the treatment of SAD has not been explored. This study aims to test the effectiveness of a VR intervention in alleviating symptoms of SAD compared to standard bright light treatment.

The investigators aim to recruit 60 participants who self-identify or have been diagnosed with SAD and who report moderate to severe symptoms. Participants are also required to be 18 years or older, a UK resident and able to access internet and attend the Anglia Ruskin University Cambridge campus. Participants will be excluded from the study if they declare suffering from epilepsy or having previously experienced adverse effects when using VR or light box devices. Participants will also be excluded if they are taking photosensitizing medications or have significant retinal pathology, or if they are currently receiving active treatment for SAD, including antidepressant medication, bright light treatment, or psychological treatment (such as Cognitive Behavioural Therapy). Recruitment will occur during the winter months, between November 2025 and March 2026.

After consenting, potential participants will be asked to complete some measures assessing their typical seasonal mood variation, to check eligibility to participate. If eligible, they will be asked to complete demographic questions and questionnaires measuring their current mood state and symptoms. Participants will then be randomly allocated to either the VR condition or the light box condition. Those allocated to the VR-condition, will be instructed to use the VR headset for 10 minutes within the first hour after waking, every day for 14 days. Those allocated to the light box intervention, will be instructed to use the light box for 30 minutes within the first hour after waking, every day for 14 days. Before and after each session, participants will be asked to record their current mood. At the end of the 14-day period, participants will return the headset or the light box and complete the final symptom and mood state questionnaires and questions regarding their experience. One week later, participants will be asked to complete a follow-up questionnaire about their mood and symptoms.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • must self-identify or have been diagnosed with SAD, with moderate to severe symptoms

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality (VR) intervention
10-min VR intervention
Device: Virtual Reality (VR) Intervention
10-min VR intervention, once a day, everyday for 14 days.
Active Comparator: Light Box (LB) intervention
30-min LB intervention
Device: Light Box (LB) intervention
30-min LB intervention once a day, everyday for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of mood and depressive symptoms
Time Frame: From baseline (day 1 to 7) to follow-up (day 28) of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant engagement, experience and satisfaction of the intervention
Time Frame: From baseline (day 1 to 7) to end of follow-up (day 28) treatment
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.
From baseline (day 1 to 7) to end of follow-up (day 28) treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglia Ruskin University

Collaborators

Reneural Technologies Ltd.
Aerial Icon Ltd.
Innovate UK, UKRI

Investigators

  • Principal Investigator: Debora Vasconcelos e Sa, PhD, Anglia Ruskin University
  • Study Director: Jane Scott, PhD, Anglia Ruskin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 27, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 28, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10149188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will be written up to be published in peer-reviewed journals and anonymised data will be submitted to an online data repository (e.g., Figshare; Open Science Foundation).

IPD Sharing Time Frame

Upon study completion December 2026.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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