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

NCT04047511 | Completed

• 1 other identifier: 59/0203/S/02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Depression; Anxiety

Keywords

virtual reality; depression; anxiety; mental health; elderly; psychotherapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

  30 minutes

• Perception of Stress Questionnaire (PSQ)

  30 minutes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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)

Device: VRTierOne; Behavioral: Group general fitness training

Control

ACTIVE COMPARATOR

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)

Behavioral: Group general fitness training; Behavioral: Group Psychoeducation

Interventions

VRTierOne DEVICE

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 Reality

Group general fitness training BEHAVIORAL

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.

Control; Virtual Reality

Group Psychoeducation BEHAVIORAL

A single sesstion will contain mini-lectures about mental well-being and psychohygiene, conduced by a psychotherapist in group form.

Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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) 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;

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Foundation for Senior Citizen Activation SIWY DYM: collaborator

Study Sites (1)

Foundation for Senior Citizen Activation SIWY DYM

Wroclaw, Lower Silesian Voivodeship, 50-240, Poland

Location

Related Publications (5)

• 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.

  PMID: 26795129 BACKGROUND

• 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.

  PMID: 28325167 BACKGROUND

• 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.

  PMID: 28475502 BACKGROUND

• 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.

  PMID: 25093964 BACKGROUND

• 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.

  PMID: 24810933 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Joanna Szczepańska-Gieracha, Professor

  University School of Physical Education, Wroclaw, Poland

  STUDY DIRECTOR

• Błażej Cieślik, MSc

  University School of Physical Education, Wroclaw, 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: Research Assistant

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 6, 2019
• Study Start: June 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: September 1, 2019
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)