NCT05285501

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

March 8, 2022

Last Update Submit

September 29, 2022

Conditions

Keywords

virtual realitydepressionanxietymental healthelderlyrehabilitationvirtual garden

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

EXPERIMENTAL

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)

Behavioral: Group general fitness trainingDevice: VRTierOne

Control

ACTIVE COMPARATOR

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)

Behavioral: Group general fitness trainingBehavioral: Group relaxation and psychoeduaction

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.

ControlVirtual Therapeutic Garden

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

Control
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.

Virtual Therapeutic Garden

Eligibility Criteria

Age60 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

University School of Physical Education

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

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: 32951730BACKGROUND
  • 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.

    PMID: 34440974BACKGROUND
  • 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.

    PMID: 33577375BACKGROUND
  • 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.

    PMID: 34062721BACKGROUND
  • 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.

    PMID: 34065625BACKGROUND
  • 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.

    PMID: 32021150BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Joanna Szczepańska-Gieracha, Professor

    University School of Physical Education, Wroclaw, Poland

    STUDY DIRECTOR
  • Błażej Ł Cieślik, PhD

    Jan Dlugosz University in Czestochowa, Poland

    PRINCIPAL INVESTIGATOR

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

Locations