NCT07530952

Brief Summary

Depression is a common mental health condition that can cause low mood, lack of energy, sleep problems, and difficulties in daily functioning. Many people with mild to moderate depression do not receive sufficient treatment because of barriers such as limited access to services, stigma, or low motivation to seek help. Physical activity and contact with nature have been shown to improve mental health, and activities performed in natural environments ("green exercise") may provide additional psychological benefits compared with indoor exercise. However, people with depression may experience barriers to engaging in outdoor activities, such as low motivation, limited access to natural environments, or unfavorable weather conditions. Virtual reality (VR) technology can simulate immersive natural environments and may provide a way to experience nature indoors. VR-mediated experiences of nature (or "virtual nature") can provide similar psychological benefits of rea-life nature experiences. Moreover, as virtual nature experiences have been found to elicit increased sense of nature connectedness and intention to perform green exercise, which may in turn support increase participation in actual green exercise. While virtual nature interventions have shown promising results in different health contexts and are considered safe and feasible, little research has examined their effects of integrating such medium within clinical standard treatments for depression. The purpose of this study is to investigate whether virtual nature can be an effective supplement to standard treatment for patients with mild to moderate depression. Specifically, the study will evaluate whether the combination of standard treatment and virtual nature improves mood and reduces depressive symptoms compared with treatment as usual. The study will also explore whether the intervention influences participants' motivation to engage in physical activity and outdoor green exercise over time. Finally, the study will examine possible differences between two approaches to deliver virtual nature experiences to patients in treatment for depression, namely a "high-end" and laboratory-based approach vs a "low-end" and self-managed approach. Participants will be recruited from a psychiatric outpatient clinic that treats individuals with depression and anxiety disorders. Eligible participants will be adults diagnosed with mild to moderate depression. Patients with additional diagnosis for dementia or psychotic illness or other serious somatic illness will be excluded. Participants will be randomly assigned to one of three groups: (1) a "high-end" and laboratory-based VR intervention combined with standard treatment, (2) a "low-end" and self-managed VR intervention combined with standard treatment, or (3) a control group receiving only standard treatment. The intervention will last three weeks, and participants will be assessed at baseline, immediately after the first session, after the intervention period, and at follow-up. The study will examine several outcomes, both to test acute and longitudinal effects. Specifically, to test for acute effects of the two VR approaches, tested outcomes include affect state, feelings of nature connectedness, intention to perform green exercise and experiences with the virtual environment (such as enjoyment, immersion, and possible side effects like cyber sickness). To test the longitudinal effects, tested outcomes include mood, symptoms of depression and anxiety, and changes in physical activity and nature connectedness. The main hypothesis is that patients who receive virtual nature in addition to their usual treatment will experience greater improvements in mood and depressive symptoms compared with patients receiving standard treatment alone. A secondary hypothesis is that exposure to virtual nature may increase participants' motivation and engagement in real-world outdoor physical activity over time. Finally, it is expected that the high-end and lab-based VR intervention will provide more positive overall effects. This research will provide new knowledge about whether virtual nature experiences can support mental health treatment and help people with depression become more physically active and connected to nature. If effective, the intervention could offer a low-cost and accessible supplement to existing treatment approaches for depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

May 5, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 26, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Beck depression inventory II (BDI-II)

    The BDI-II is a 21-item self-report questionnaire designed to measure the severity of depression. The total score is calculated by summing the ratings (0-3) for all 21 items, with minimum score 0 (no or minimal depressive symptoms) and maximum score 63 (severe, high-level depressive symptoms). A Norwegian translation of the scale commonly used in clinical settings is used in the study.

    Baseline; post-intervention (week 3); follow-up (week 12).

  • Beck anxiety inventory (BAI)

    The BAI is a 21-item self-report questionnaire used to measure the severity of anxiety in adults and adolescents. Each item is rated from 0 ("not at all") to 3 ("a lot"). The total score is calculated by summing the ratings for all 21 items (minimum value 0 and maximum value 63), with higher scores indicating greater severity of anxiety. A Norwegian translation of the scale commonly used in clinical settings is used in the study.

    Baseline; post-intervention (week 3); follow-up (week 12).

Secondary Outcomes (5)

  • Hopkins symptom checklist (HSCL-10)

    Baseline; post-intervention (week 3); follow-up (week 12).

  • Leisure time exercise questionnaire (LTEQ)

    Baseline; post-intervention (week 3); follow-up (week 12).

  • Intention to perform green exercise (INT-GE)

    Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

  • Connectedness with nature scale (CNS)

    Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

  • Affect Scale (PAAS)

    Baseline; immediately after the 1st VR exposure; post-intervention (week 3); follow-up (week 12).

Other Outcomes (4)

  • Enjoyment during the VR experience

    Immediately after the 1st VR exposure

  • Sense of presence during the VR experience

    Immediately after the 1st VR exposure

  • Simulator sickness questionnaire (SSQ)

    Immediately after the 1st VR exposure

  • +1 more other outcomes

Study Arms (3)

Control (TAU)

ACTIVE COMPARATOR

Standard treatment with therapist

Other: Standard Treatment

Studio-based

EXPERIMENTAL
Other: Studio-based VR experiencesOther: Standard Treatment

Self-managed

EXPERIMENTAL
Other: Self-managed VR experiencesOther: Standard Treatment

Interventions

High-end VR experience delivered by the researcher in a studio, delivered weekly, consisting of a simulated nature walk delivered through a high-end VR system connected to a manually-driven treadmill.

Studio-based

Low-end VR experience self-managed by the participants. After an introductory meeting with the researcher, the participants receive, for the duration of the intervention, a standalone VR headset containing a pre-set library of virtual nature experiences. The participants are encouraged to use the headset daily. The time spent using the VR headset is recorded through the device.

Self-managed

Standard treatment with therapist

Control (TAU)Self-managedStudio-based

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to speak and read in Norwegian
  • diagnosed with mild to moderate depression

You may not qualify if:

  • additional diagnosis for dementia or psychotic illness or other serious somatic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehus Innlandet

Hamar, Norway

Location

Related Links

MeSH Terms

Conditions

DepressionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 15, 2026

Study Start

February 1, 2022

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations