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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immersive Virtual Therapy as a Method Supporting the Non-Farmacological Treatment of Late-Life Depression

Conditions
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Depressive Symptoms, Depression, Anxiety

Intervention / Treatment
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* Device: VRTierOne
* Behavioral: Group general fitness training
* Behavioral: Group Psychoeducation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>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<br>* 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.<br>Behavioral: Group general fitness training<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* 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.<br>Behavioral: Group Psychoeducation<br>* A single sesstion will contain mini-lectures about mental well-being and psychohygiene, conduced by a psychotherapist in group form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 
| 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. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychotherapy, rehabilitation, virtual reality, depression, anxiety, mental health, elderly