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Virtual Therapy as a Method Supporting Treatment of Late-Life Depression

Primary Purpose

Depressive Symptoms, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
VRTierOne
Group general fitness training
Group Psychoeducation
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, psychotherapy, rehabilitation

Eligibility Criteria

60 Years - 80 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) or 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

  • Foundation for Senior Citizen Activation SIWY DYM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality

Control

Arm Description

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

Twice a week, for a 4 consecutive weeks: 8 sessions of group psychoeducation and relaxation (20 minutes each) 8 sessions of general fitness training (40 minutes each)

Outcomes

Primary Outcome Measures

The Geriatric Depression Scale (GDS)
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)
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.
Perception of Stress Questionnaire (PSQ)
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.

Full Information

First Posted
July 31, 2019
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
NCT04047511
Brief Title
Virtual Therapy as a Method Supporting Treatment of Late-Life Depression
Official Title
Immersive Virtual Therapy as a Method Supporting the Non-Farmacological Treatment of Late-Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
September 1, 2019 (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, psychotherapy, rehabilitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Twice a week, for a 4 consecutive weeks: 8 sessions of VRTierOne therapy ( 20 minutes each) 8 sessions of general fitness training (40 minutes each)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Twice a week, for a 4 consecutive weeks: 8 sessions of group psychoeducation and relaxation (20 minutes each) 8 sessions of general fitness training (40 minutes each)
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.
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). Perception of effort will be monitored using the Borg 6-20 rating the perceived exertion. Conducted by a physiotherapist in group form.
Intervention Type
Behavioral
Intervention Name(s)
Group Psychoeducation
Intervention Description
A single sesstion will contain mini-lectures about mental well-being and psychohygiene, conduced by a psychotherapist in group form.
Primary Outcome Measure Information:
Title
The Geriatric Depression Scale (GDS)
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)
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
Title
Perception of Stress Questionnaire (PSQ)
Description
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 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) or 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 Cieślik, MSc
Organizational Affiliation
University School of Physical Education, Wroclaw, Poland
Official's Role
Principal Investigator
Facility Information:
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
26795129
Citation
Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence. Psychiatry Res. 2016 Feb 28;236:189-195. doi: 10.1016/j.psychres.2016.01.015. Epub 2016 Jan 12.
Results Reference
background
PubMed Identifier
28325167
Citation
Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.
Results Reference
background
PubMed Identifier
28475502
Citation
Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
Results Reference
background
PubMed Identifier
25093964
Citation
McCann RA, Armstrong CM, Skopp NA, Edwards-Stewart A, Smolenski DJ, June JD, Metzger-Abamukong M, Reger GM. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014 Aug;28(6):625-31. doi: 10.1016/j.janxdis.2014.05.010. Epub 2014 Jun 7.
Results Reference
background
PubMed Identifier
24810933
Citation
Li J, Theng YL, Foo S. Game-based digital interventions for depression therapy: a systematic review and meta-analysis. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):519-27. doi: 10.1089/cyber.2013.0481. Epub 2014 May 8.
Results Reference
background

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Virtual Therapy as a Method Supporting Treatment of Late-Life Depression

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