Virtual Therapeutic Garden for Depressive Symptoms
Immersive Virtual Therapeutic Garden as a Support for Late-Life Depressive Symptoms: a Randomized Clinical Trial
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
March 8, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedSeptember 30, 2022
September 1, 2022
4 months
March 8, 2022
September 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
15 minutes
Secondary Outcomes (1)
Hospital Anxiety and Depression Scale (HADS)(Change from baseline)
30 minutes
Study Arms (2)
Virtual Therapeutic Garden
EXPERIMENTALTwice a week, for a 4 consecutive weeks: 8 sessions of general fitness training (40 minutes each) 8 sessions of VRTierOne therapy (20 minutes each)
Control
ACTIVE 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)
Interventions
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.
A single session of relaxation (10 minutes) psychoeducation (10 minutes) will contain minilectures about mental well-being and psychohygiene. In summary 20 minutes.
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.
Eligibility Criteria
You may qualify if:
- GDS≥10 or HADS-A≥8 or HADS-D≥8
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Foundation for Senior Citizen Activation SIWY DYM
Wroclaw, Lower Silesian Voivodeship, 50-240, Poland
University School of Physical Education
Wroclaw, Lower Silesian Voivodeship, 51-612, Poland
Related Publications (7)
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.
PMID: 32951730BACKGROUNDJozwik 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.
PMID: 34440974BACKGROUNDSzczepanska-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.
PMID: 33577375BACKGROUNDSzczepanska-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.
PMID: 34062721BACKGROUNDJozwik 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.
PMID: 34065625BACKGROUNDRutkowski 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.
PMID: 32021150BACKGROUNDCieslik 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.
PMID: 37360811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joanna Szczepańska-Gieracha, Professor
University School of Physical Education, Wroclaw, Poland
- PRINCIPAL INVESTIGATOR
Błażej Ł Cieślik, PhD
Jan Dlugosz University in Czestochowa, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 17, 2022
Study Start
March 15, 2022
Primary Completion
June 30, 2022
Study Completion
July 31, 2022
Last Updated
September 30, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share