Anxiety and DepressionVITALISENCT04925765
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
A study testing Virtual Reality Biofeedback Session in people with Anxiety and Depression and Postpartum Depression, run by Grace Lim, MD, MS at 1 site in United States.
Trial summary
The purpose of this study is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Depression, Postpartum Depression, Pregnancy Related
- What is being tested?
- Virtual Reality Biofeedback Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently pregnant or postpartum (delivery within 3 months)
- 18 years or older
Who cannot join
- Unable to participate in study procedures
- English illiterate (surveys validated in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes.
Read the detailed description
In an open-label pilot trial, women will undergo a single session using the virtual reality biofeedback program. The objective of this study is to assess feasibility and acceptability of virtual reality biofeedback program in postpartum women with specific assessments of anxiety and depression outcomes.
- Being tested
- Virtual Reality Biofeedback Session
- Medical subject headings
- Anxiety Disorders, Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Biofeedback SessionOther
The "Flowly" intervention treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Session | Experimental | All participants in this study will complete a 1 hour virtual reality session. Receives: Other: Virtual Reality Biofeedback Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Patient response to the feasibility of VR use. The question asked was, "I was able to do the session without difficulty," which was measured on a Likert Scale of 1-5. A score of 1 is indicative of great difficulty present and a score of 5 is indicative of no difficulty present. Outcome measurement is presented as an averaged score with standard deviation among participating patients.
Measured: Completed immediately after the VR session.
Intervention Acceptability
Acceptability was assessed by questions, "Would you participate in another session?" Acceptability was measured by yes/no responses and reported as an overall percentage of participating patients who responded as yes.
Measured: Completed directly after the VR intervention session and anxiety/depression measurements.
Secondary outcomes (2)
Decrease in Depression From Baseline to Post-intervention
Number of participants whose depression scores (as measured by Edinburgh Postnatal depression scale (EPDS)) decreased from baseline to post-VR intervention.
Measured: EPDS Completed directly before and after VR session.
Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention
Number of participants whose anxiety scores (as measured by STAI) decreased from baseline to post-VR intervention.
Measured: Completed directly before and after VR session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Sep 2021
- Primary completion30 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety and DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD,MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925765
- Sponsor's protocol ID
- STUDY21040063
- Acronym
- VITALISE
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2021
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.
PubMed 29914574Kolbe L, Jaywant A, Gupta A, Vanderlind WM, Jabbour G. Use of virtual reality in the inpatient rehabilitation of COVID-19 patients. Gen Hosp Psychiatry. 2021 Jul-Aug;71:76-81. doi: 10.1016/j.genhosppsych.2021.04.008. Epub 2021 Apr 29.
PubMed 33964789Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.
PubMed 34036696Vlake JH, Van Bommel J, Wils EJ, Korevaar TIM, Hellemons ME, Schut AFC, Labout JAM, Schreuder LLH, Gommers D, Van Genderen ME. Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial. Trials. 2021 May 5;22(1):328. doi: 10.1186/s13063-021-05271-z.
PubMed 33952318Sasseville M, LeBlanc A, Boucher M, Dugas M, Mbemba G, Tchuente J, Chouinard MC, Beaulieu M, Beaudet N, Skidmore B, Cholette P, Aspiros C, Larouche A, Chabot G, Gagnon MP. Digital health interventions for the management of mental health in people with chronic diseases: a rapid review. BMJ Open. 2021 Apr 5;11(4):e044437. doi: 10.1136/bmjopen-2020-044437.
PubMed 33820786Alneyadi M, Drissi N, Almeqbaali M, Ouhbi S. Biofeedback-Based Connected Mental Health Interventions for Anxiety: Systematic Literature Review. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e26038. doi: 10.2196/26038.
PubMed 33792548Polat M, Kahveci A, Muci B, Gunendi Z, Kaymak Karatas G. The Effect of Virtual Reality Exercises on Pain, Functionality, Cardiopulmonary Capacity, and Quality of Life in Fibromyalgia Syndrome: A Randomized Controlled Study. Games Health J. 2021 Jun;10(3):165-173. doi: 10.1089/g4h.2020.0162. Epub 2021 Mar 9.
PubMed 33689452Turrado V, Guzman Y, Jimenez-Lillo J, Villegas E, de Lacy FB, Blanch J, Balibrea JM, Lacy A. Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial. Surg Endosc. 2021 Jul;35(7):4042-4047. doi: 10.1007/s00464-021-08407-z. Epub 2021 Mar 8.
PubMed 33683433
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Biofeedback for Postpartum Anxiety and Depression
- ClinicalTrials.gov ID
- NCT04925765
- Acronym / sponsor ID
- VITALISE / STUDY21040063
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Grace Lim, MD, MSUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes.
Detailed description
In an open-label pilot trial, women will undergo a single session using the virtual reality biofeedback program. The objective of this study is to assess feasibility and acceptability of virtual reality biofeedback program in postpartum women with specific assessments of anxiety and depression outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Session | Experimental | Other: Virtual Reality Biofeedback SessionAll participants in this study will complete a 1 hour virtual reality session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently pregnant or postpartum (delivery within 3 months)
- 18 years or older
Key exclusion criteria (2 listed)
- Unable to participate in study procedures
- English illiterate (surveys validated in English)
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 Biofeedback SessionThe "Flowly" intervention treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression. | Other | Virtual Reality (VR) Session |
Primary outcome
Intervention Feasibility
Time frame: Completed immediately after the VR session.
Patient response to the feasibility of VR use. The question asked was, "I was able to do the session without difficulty," which was measured on a Likert Scale of 1-5. A score of 1 is indicative of great difficulty present and a score of 5 is indicative of no difficulty present. Outcome measurement is presented as an averaged score with standard deviation among participating patients.
Intervention Acceptability
Time frame: Completed directly after the VR intervention session and anxiety/depression measurements.
Acceptability was assessed by questions, "Would you participate in another session?" Acceptability was measured by yes/no responses and reported as an overall percentage of participating patients who responded as yes.
2 secondary outcomes
Decrease in Depression From Baseline to Post-intervention
Time frame: EPDS Completed directly before and after VR session.
Decrease in State-Trait Anxiety Inventory (STAI) From Baseline to Post-intervention
Time frame: Completed directly before and after VR session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29914574Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.
- Background: PubMed 33964789Kolbe L, Jaywant A, Gupta A, Vanderlind WM, Jabbour G. Use of virtual reality in the inpatient rehabilitation of COVID-19 patients. Gen Hosp Psychiatry. 2021 Jul-Aug;71:76-81. doi: 10.1016/j.genhosppsych.2021.04.008. Epub 2021 Apr 29.
- Background: PubMed 34036696Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.
- Background: PubMed 33952318Vlake JH, Van Bommel J, Wils EJ, Korevaar TIM, Hellemons ME, Schut AFC, Labout JAM, Schreuder LLH, Gommers D, Van Genderen ME. Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial. Trials. 2021 May 5;22(1):328. doi: 10.1186/s13063-021-05271-z.
- Background: PubMed 33820786Sasseville M, LeBlanc A, Boucher M, Dugas M, Mbemba G, Tchuente J, Chouinard MC, Beaulieu M, Beaudet N, Skidmore B, Cholette P, Aspiros C, Larouche A, Chabot G, Gagnon MP. Digital health interventions for the management of mental health in people with chronic diseases: a rapid review. BMJ Open. 2021 Apr 5;11(4):e044437. doi: 10.1136/bmjopen-2020-044437.
- Background: PubMed 33792548Alneyadi M, Drissi N, Almeqbaali M, Ouhbi S. Biofeedback-Based Connected Mental Health Interventions for Anxiety: Systematic Literature Review. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e26038. doi: 10.2196/26038.
- Background: PubMed 33689452Polat M, Kahveci A, Muci B, Gunendi Z, Kaymak Karatas G. The Effect of Virtual Reality Exercises on Pain, Functionality, Cardiopulmonary Capacity, and Quality of Life in Fibromyalgia Syndrome: A Randomized Controlled Study. Games Health J. 2021 Jun;10(3):165-173. doi: 10.1089/g4h.2020.0162. Epub 2021 Mar 9.
- Background: PubMed 33683433Turrado V, Guzman Y, Jimenez-Lillo J, Villegas E, de Lacy FB, Blanch J, Balibrea JM, Lacy A. Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial. Surg Endosc. 2021 Jul;35(7):4042-4047. doi: 10.1007/s00464-021-08407-z. Epub 2021 Mar 8.
- 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.
Grace Lim, MD,MS principal investigator
University of Pittsburgh
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 Biofeedback Session in people with Anxiety and Depression and Postpartum Depression, run by Grace Lim, MD, MS at 1 site in United States.
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 2 inclusion and 2 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 17 Apr 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Feasibility (time frame: Completed immediately after the VR session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925765, which also lists 8 linked publications.
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 17 Apr 2024.