Virtual Reality Digital Therapeutics for Seasonal Affective Disorder

NCT ID: NCT07161570

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2026-12-31

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Virtual reality (VR) intervention

10-min VR intervention

Group Type: EXPERIMENTAL

Virtual Reality (VR) Intervention

Intervention Type: DEVICE

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

Light Box (LB) intervention

30-min LB intervention

Group Type: ACTIVE_COMPARATOR

Light Box (LB) intervention

Intervention Type: DEVICE

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

Interventions

Virtual Reality (VR) Intervention

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

Intervention Type: DEVICE

Light Box (LB) intervention

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reneural Technologies Ltd.

UNKNOWN

Sponsor Role: collaborator

Aerial Icon Ltd.

UNKNOWN

Sponsor Role: collaborator

Innovate UK, UKRI

UNKNOWN

Sponsor Role: collaborator

Anglia Ruskin University

OTHER

Sponsor Role: lead

Responsible Party

Debora de Vasconcelos e Sa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debora Vasconcelos e Sa, PhD

Role: PRINCIPAL_INVESTIGATOR

Anglia Ruskin University

Jane Scott, PhD

Role: STUDY_DIRECTOR

Anglia Ruskin University

Central Contacts

Jane Scott, PhD

Role: CONTACT

jane.scott@aru.ac.uk

+44 1223698355

Debora Vasconcelos e Sa, PhD

Role: CONTACT

debora.sa@aru.ac.uk

Other Identifiers

10149188

Identifier Type: -

Identifier Source: org_study_id