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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention for Anxiety and Depression in Children, Adolescents, and Adults

NCT07250971

Anxiety Disorders Depressive Disorders

COMPLETED NA

Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy

NCT07324577

Radiation Therapy Virtual Reality

NOT_YET_RECRUITING NA

Virtual Reality for Mental Well-being in Older People With Physical Disabilities

NCT05818579

Mental Health Wellness 1 Physical Disability

UNKNOWN NA

Feasibility Study on an Immersive Virtual Reality Tool in the Treatment of Chronic Low Back Pain

NCT04781465

Chronic Low-back Pain

UNKNOWN NA

Virtual Reality Assisted Conscious Sedation During TAVI

NCT04259723

Severe Aortic Valve Stenosis Anxiety Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Symptoms Depression Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Reality

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)

Group Type EXPERIMENTAL

VRTierOne

Intervention Type 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.

Group general fitness training

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Group general fitness training

Intervention Type 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.

Group Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VRTierOne

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 DEVICE

Group general fitness training

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

Group Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No