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Virtual Therapeutic Garden for Depressive Symptoms

Primary Purpose

Depressive Symptoms, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Group general fitness training
Group relaxation and psychoeduaction
VRTierOne
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring virtual reality, depression, anxiety, mental health, elderly, rehabilitation, virtual garden

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • GDS≥10 or HADS-A≥8 or HADS-D≥8

Exclusion Criteria:

  • 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;

Sites / Locations

  • University School of Physical Education
  • Foundation for Senior Citizen Activation SIWY DYM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Therapeutic Garden

Control

Arm Description

Twice a week, for a 4 consecutive weeks: 8 sessions of general fitness training (40 minutes each) 8 sessions of VRTierOne therapy (20 minutes each)

Twice 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 8, 2022
Last Updated
September 29, 2022
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
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1. Study Identification

Unique Protocol Identification Number
NCT05285501
Brief Title
Virtual Therapeutic Garden for Depressive Symptoms
Official Title
Immersive Virtual Therapeutic Garden as a Support for Late-Life Depressive Symptoms: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depression, Anxiety
Keywords
virtual reality, depression, anxiety, mental health, elderly, rehabilitation, virtual garden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Therapeutic Garden
Arm Type
Experimental
Arm Description
Twice a week, for a 4 consecutive weeks: 8 sessions of general fitness training (40 minutes each) 8 sessions of VRTierOne therapy (20 minutes each)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Twice 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)
Intervention Type
Behavioral
Intervention Name(s)
Group general fitness training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group relaxation and psychoeduaction
Intervention Description
A single session of relaxation (10 minutes) psychoeducation (10 minutes) will contain minilectures about mental well-being and psychohygiene. In summary 20 minutes.
Intervention Type
Device
Intervention Name(s)
VRTierOne
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Geriatric Depression Scale (GDS)(Change from baseline)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)(Change from baseline)
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: GDS≥10 or HADS-A≥8 or HADS-D≥8 Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Professor
Organizational Affiliation
University School of Physical Education, Wroclaw, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Błażej Ł Cieślik, PhD
Organizational Affiliation
Jan Dlugosz University in Czestochowa, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University School of Physical Education
City
Wroclaw
State/Province
Lower Silesia
ZIP/Postal Code
51-612
Country
Poland
Facility Name
Foundation for Senior Citizen Activation SIWY DYM
City
Wrocław
State/Province
Lower Silesia
ZIP/Postal Code
50-240
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32951730
Citation
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.
Results Reference
background
PubMed Identifier
34440974
Citation
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.
Results Reference
background
PubMed Identifier
33577375
Citation
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.
Results Reference
background
PubMed Identifier
34062721
Citation
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.
Results Reference
background
PubMed Identifier
34065625
Citation
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.
Results Reference
background
PubMed Identifier
32021150
Citation
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.
Results Reference
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Virtual Therapeutic Garden for Depressive Symptoms

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