NCT07790627

Brief 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

June 7, 2026

Last Update Submit

August 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (4)

  • anxiety

    6 weeks

  • functional capacity

    6 weeks

  • sequential attendance of pulmonary rehabilitation sessions

    12 sessions

  • compliance with medication

    12 sessions

Study Arms (2)

Experimental group

EXPERIMENTAL
Device: virtual reality with pulmonary rehabilitation

controlled group

OTHER

controlled group received pulmonary rehabilitation

Other: controlled group received pulmonary rehabilitation without utilizing virtual reality

Interventions

Virtual reality was utilized with pulmonary rehabilitation in COPD patients in the expiremental group

Experimental group

controlled group received pulmonary rehabilitation without utilizing virtual reality

controlled group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qatif Central Hospital

Dammam, Eastern Province, Saudi Arabia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2026

First Posted

August 27, 2026

Study Start

February 2, 2026

Primary Completion

May 21, 2026

Study Completion

May 21, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations