Seasonal Affective Disorder (SAD)VR-SADNCT07161570
Virtual Reality Digital Therapeutics for Seasonal Affective Disorder
A study testing Virtual Reality (VR) Intervention and Light Box (LB) intervention in people with Seasonal Affective Disorder (SAD), run by Anglia Ruskin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder (SAD)
- What is being tested?
- Virtual Reality (VR) Intervention and Light Box (LB) intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Debora Vasconcelos e Sa, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Seasonal Affective Disorder (SAD)
- Being tested
- Virtual Reality (VR) Intervention, Light Box (LB) intervention
- Keywords
- SAD, VR
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) InterventionDevice
10-min VR intervention, once a day, everyday for 14 days.
Light Box (LB) interventionDevice
30-min LB intervention once a day, everyday for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) intervention | Experimental | 10-min VR intervention Receives: Device: Virtual Reality (VR) Intervention |
| Light Box (LB) intervention | Active comparator | 30-min LB intervention Receives: Device: Light Box (LB) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From baseline (day 1 to 7) to end of follow-up (day 28) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start27 Oct 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Affective Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Reneural Technologies Ltd., Aerial Icon Ltd., Innovate UK, UKRI
- Responsible party
- Principal investigator, Debora de Vasconcelos e Sa, Anglia Ruskin University
- Investigators
- Debora Vasconcelos e Sa, PhD, Principal investigator, Anglia Ruskin UniversityJane Scott, PhD, Study director, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161570
- Sponsor's protocol ID
- 10149188
- Acronym
- VR-SAD
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Digital Therapeutics for Seasonal Affective Disorder.
- ClinicalTrials.gov ID
- NCT07161570
- Acronym / sponsor ID
- VR-SAD / 10149188
- Conditions
- Seasonal Affective Disorder (SAD)
- Keywords
- SAD, VR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Reneural Technologies Ltd., Aerial Icon Ltd., Innovate UK, UKRI
- Study start
- 27 Oct 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) intervention | Experimental | Device: Virtual Reality (VR) Intervention10-min VR intervention |
| Light Box (LB) intervention | Active comparator | Device: Light Box (LB) intervention30-min LB intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) Intervention10-min VR intervention, once a day, everyday for 14 days. | Device | Virtual reality (VR) intervention |
| Light Box (LB) intervention30-min LB intervention once a day, everyday for 14 days. | Device | Light Box (LB) intervention |
Primary outcome
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).
1 secondary outcome
Participant engagement, experience and satisfaction of the intervention
Time frame: From baseline (day 1 to 7) to end of follow-up (day 28) treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. 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).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debora Vasconcelos e Sa, PhD contact
Debora Vasconcelos e Sa, PhD principal investigator
Anglia Ruskin University
Jane Scott, PhD study director
Anglia Ruskin University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) Intervention and Light Box (LB) intervention in people with Seasonal Affective Disorder (SAD), run by Anglia Ruskin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Scott, PhD (+44 1223698355, jane.scott@aru.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of mood and depressive symptoms (time frame: From baseline (day 1 to 7) to follow-up (day 28) of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.