COPD PatientsNCT07790627
Effect of Utilizing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients
A study testing virtual reality with pulmonary rehabilitation in people with COPD Patients and Depression in Chronic Obstructive Pulmonary Disease, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
The goal of this study is to find the effect of utilizing virtual reality with pulmonary rehabilitation on depression in COPD patients. The main question it aims to answer is: Does utilizing virtual reality with pulmonary rehabilitation reduce depression in COPD patients? Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- COPD Patients, Depression in Chronic Obstructive Pulmonary Disease
- What is being tested?
- virtual reality with pulmonary rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Feb 2026to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of COPD, aged between 45 and 85 years and presenting with depression according to the score of BDI-II with a cut off of 14 at the baseline assessment.
Who cannot join
- Absence of depression based on BDI-II score, presence of serious psychiatric disorders at the time of evaluation or documented in the medical records, initiation of psychiatric treatment during the study period, contraindications for virtual reality exposure such as (significant vision issues, significant hearing issues, severe motion sickness, seizure disorders) and the patient's refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Utilzing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients: A Randomized Controlled Trial
The goal of this study is to find the effect of utilizing virtual reality with pulmonary rehabilitation on depression in COPD patients. The main question it aims to answer is: Does utilizing virtual reality with pulmonary rehabilitation reduce depression in COPD patients?
- Being tested
- virtual reality with pulmonary rehabilitation, controlled group received pulmonary rehabilitation without utilizing virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality with pulmonary rehabilitationDevice
Virtual reality was utilized with pulmonary rehabilitation in COPD patients in the expiremental group
controlled group received pulmonary rehabilitation without utilizing virtual realityOther
controlled group received pulmonary rehabilitation without utilizing virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: virtual reality with pulmonary rehabilitation |
| controlled group | Other | controlled group received pulmonary rehabilitation Receives: Other: controlled group received pulmonary rehabilitation without utilizing virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
The primary outcome was the change in the depression score from baseline to post intervention. Depression was assessed prior to the first session of pulmonary rehabilitation program and reassessed after the completion of the twelfth session by Beck's Depression Inventory-II (BDI-II).
BDI-II is a 21 item questionnaire which measures the severity of depression in adults and adolescents. It is structured on a 4 point rating scale for each question from 0 indicating no presence of any symptoms and 3 indicating that symptoms strongly present. Total scores from 0 to 13 indicate no or minimal depression, scores from 14 to 19 indicate mild depression, while scores from 20 to 28 indicate moderate depression, and scores from 29 to 63 indicate severe depression (Beck, A. T., 1996; NaviauxLab., 2020; Rahat et al., 2012).
Patients with depressive symptoms score with a cut off of 14 as mild score indicating clinically significant were included in the study.
Measured: 6 weeks
Secondary outcomes (4)
anxiety
Anxiety was assessed and reassessed by the anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A) (Rishi et al., 2017). The HAD is considered a valid research tool (Mihalca \& Pilecka, 2015). Anxiety was assessed and reassessed pre and post intervention as a secondary outcome measure.
HADS is a 14 item scale designed to assess the anxiety and depression. Every question of the 14 items has a score between 0 and 3. It includes two subscales: seven questions (HADS-A) to assess anxiety and seven questions (HADS-D) to assess depression. With an acceptable score of 8/21 for anxiety and 8/21 for depression, the total score is from 0 to 42.
Measured: 6 weeks
functional capacity
The functional capacity was assessed and reassessed by the 6 minute walking test (6MWT) (heartonline, 2024).
6MWT is a self-paced exercise assessment widely utilized in hospitals and community settings to evaluate functional capacity, especially in patients with cardiovascular and respiratory conditions. It measures the distance a patient can walk over a period of six minutes on a flat hard surface. It is based on guidelines established by the European Respiratory Society and the American Thoracic Society (heartonline, 2024).
Measured: 6 weeks
sequential attendance of pulmonary rehabilitation sessions
Sequential attendance of pulmonary rehabilitation sessions was recorded by a data sheet. It was calculated as frequencies.
This means to calculate patients attendance of the twelve sessions within the prescribed six weeks period at frequency of two sessions per week in sequence without absence in between.
Measured: 12 sessions
compliance with medication
Compliance with medication was recorded using a data sheet. It was obtained every session subjectively according to the patients' words regarding their compliance with their medications. It was calculated as frequency and percentage.
Measured: 12 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start2 Feb 2026
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790627
- Sponsor's protocol ID
- IRB-PGS-2026-03-0095
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Utilzing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07790627
- Acronym / sponsor ID
- IRB-PGS-2026-03-0095
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 27 Aug 2026 (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.
The goal of this study is to find the effect of utilizing virtual reality with pulmonary rehabilitation on depression in COPD patients. The main question it aims to answer is: Does utilizing virtual reality with pulmonary rehabilitation reduce depression in COPD patients?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: virtual reality with pulmonary rehabilitation |
| controlled group | Other | Other: controlled group received pulmonary rehabilitation without utilizing virtual realitycontrolled group received pulmonary rehabilitation |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of COPD, aged between 45 and 85 years and presenting with depression according to the score of BDI-II with a cut off of 14 at the baseline assessment.
Key exclusion criteria (1 listed)
- Absence of depression based on BDI-II score, presence of serious psychiatric disorders at the time of evaluation or documented in the medical records, initiation of psychiatric treatment during the study period, contraindications for virtual reality exposure such as (significant vision issues, significant hearing issues, severe motion sickness, seizure disorders) and the patient's refusal to participate.
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 with pulmonary rehabilitationVirtual reality was utilized with pulmonary rehabilitation in COPD patients in the expiremental group | Device | Experimental group |
| controlled group received pulmonary rehabilitation without utilizing virtual realitycontrolled group received pulmonary rehabilitation without utilizing virtual reality | Other | controlled group |
Primary outcome
depression
Time frame: 6 weeks
The primary outcome was the change in the depression score from baseline to post intervention. Depression was assessed prior to the first session of pulmonary rehabilitation program and reassessed after the completion of the twelfth session by Beck's Depression Inventory-II (BDI-II). BDI-II is a 21 item questionnaire which measures the severity of depression in adults and adolescents. It is structured on a 4 point rating scale for each question from 0 indicating no presence of any symptoms and 3 indicating that symptoms strongly present. Total scores from 0 to 13 indicate no or minimal depression, scores from 14 to 19 indicate mild depression, while scores from 20 to 28 indicate moderate depression, and scores from 29 to 63 indicate severe depression (Beck, A. T., 1996; NaviauxLab., 2020; Rahat et al., 2012). Patients with depressive symptoms score with a cut off of 14 as mild score indicating clinically significant were included in the study.
4 secondary outcomes
anxiety
Time frame: 6 weeks
functional capacity
Time frame: 6 weeks
sequential attendance of pulmonary rehabilitation sessions
Time frame: 12 sessions
compliance with medication
Time frame: 12 sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality with pulmonary rehabilitation in people with COPD Patients and Depression in Chronic Obstructive Pulmonary Disease, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression (time frame: 6 weeks). 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 27 Aug 2026.