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Depressive SymptomsNCT05285501

Virtual Therapeutic Garden for Depressive Symptoms

A study testing Group general fitness training, Group relaxation and psychoeduaction and VRTierOne in people with Depressive Symptoms and Depression, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. Half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone. Read more about this study

Who is it for?
Ages 60 to 85 years, women only
Conditions the study is for
Depressive Symptoms, Depression, Anxiety
What is being tested?
Group general fitness training, Group relaxation and psychoeduaction and VRTierOne
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesPoland
Study dates
15 Mar 2022to 31 Jul 2022
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 60 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • GDS≥10 or HADS-A≥8 or HADS-D≥8

Who cannot join

  • cognitive impairment (MMSE<24);
  • aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE;
  • contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
  • substance abuse;
  • participation in another therapeutic project or individual psychotherapy;
  • antidepressant treatment;

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • Foundation for Senior Citizen Activation SIWY DYM

    Wroclaw, Lower Silesian Voivodeship, 50-240

  • University School of Physical Education

    Wroclaw, Lower Silesian Voivodeship, 51-612

Other trials in Poland

About this study

Official title: Immersive Virtual Therapeutic Garden as a Support for Late-Life Depressive Symptoms: a Randomized Clinical Trial

This study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. Half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.

Read the detailed description

Depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). The multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. However, there is still a percentage of older people who do not show improvement in depressive symptoms.

In recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. A systematic review from 2018 concluded that VR treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients.

Therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.

Being tested
Group general fitness training, Group relaxation and psychoeduaction, VRTierOne
Keywords
virtual reality, depression, anxiety, mental health, elderly, rehabilitation, virtual garden
Medical subject headings
Depression, Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group general fitness trainingBehavioural

    A single session of general fitness training will be composed of low-intensity, general-fitness exercises. Most of the exercises will be carried out in a sitting position and standing positon. The session will contain aerobic (general warm-up), musculo-articular (strengthening muscles and joints range of motion) and stabilizing exercises (improve spatio-visual coordination). Conducted by a physiotherapist in group form.

  • Group relaxation and psychoeduactionBehavioural

    A single session of relaxation (10 minutes) psychoeducation (10 minutes) will contain minilectures about mental well-being and psychohygiene. In summary 20 minutes.

  • VRTierOneDevice

    As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion "VRTierOne" Stolgraf® provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the lector (therapist) tells the patient a symbolic story about his/her situation. By performing tasks in the virtual garden, the patient influences the course of this story, becomes an active participant of the therapeutic process and sees the effects his work.

Study groups in NCT05285501
Study groupRoleWhat they receive
Virtual Therapeutic GardenExperimentalTwice a week, for a 4 consecutive weeks: 8 sessions of general fitness training (40 minutes each) 8 sessions of VRTierOne therapy (20 minutes each)
Receives: Behavioral: Group general fitness training; Device: VRTierOne
ControlActive comparatorTwice a week, for a 4 consecutive weeks: 8 sessions of general fitness training (40 minutes each) 8 sessions of group relaxation and psychoeducation (20 minutes each)
Receives: Behavioral: Group general fitness training; Behavioral: Group relaxation and psychoeduaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Geriatric Depression Scale (GDS)(Change from baseline)

    The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a "Yes/No" format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression.

    Measured: 15 minutes

Secondary outcomes (1)

  1. Hospital Anxiety and Depression Scale (HADS)(Change from baseline)

    The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start15 Mar 2022
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285501
Sponsor's protocol ID
59/0203/S/05
Status last verified
Sep 2022
First submitted
8 Mar 2022
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cieslik B, Mazurek J, Rutkowski S, Kiper P, Turolla A, Szczepanska-Gieracha J. Virtual reality in psychiatric disorders: A systematic review of reviews. Complement Ther Med. 2020 Aug;52:102480. doi: 10.1016/j.ctim.2020.102480. Epub 2020 Jun 9.

    PubMed 32951730

  • Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.

    PubMed 34440974

  • Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.

    PubMed 33577375

  • Szczepanska-Gieracha J, Cieslik B, Serweta A, Klajs K. Virtual Therapeutic Garden: A Promising Method Supporting the Treatment of Depressive Symptoms in Late-Life: A Randomized Pilot Study. J Clin Med. 2021 May 1;10(9):1942. doi: 10.3390/jcm10091942.

    PubMed 34062721

  • Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.

    PubMed 34065625

  • Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.

    PubMed 32021150

  • Cieslik B, Juszko K, Kiper P, Szczepanska-Gieracha J. Immersive virtual reality as support for the mental health of elderly women: a randomized controlled trial. Virtual Real. 2023 May 7:1-9. doi: 10.1007/s10055-023-00797-w. Online ahead of print.

    PubMed 37360811

Questions about this trial

What is this clinical trial studying?

A study testing Group general fitness training, Group relaxation and psychoeduaction and VRTierOne in people with Depressive Symptoms and Depression, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.

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 6 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. 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?

The Geriatric Depression Scale (GDS)(Change from baseline) (time frame: 15 minutes). 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 NCT05285501, which also lists 7 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 30 Sep 2022.

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