Virtual Therapeutic Garden for Depressive Symptoms

Not Applicable

Completed

• Conditions: Depression; Depressive Symptoms; Anxiety
• Interventions: Behavioral: Group general fitness training; Behavioral: Group relaxation and psychoeduaction; Device: VRTierOne

• Registration Number: NCT05285501
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

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.

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study Start: 2022-03-15
• Study First Posted: 2022-03-17
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• GDS≥10 or HADS-A≥8 or HADS-D≥8

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Therapeutic Garden	Group general fitness training	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)
Control	Group relaxation and psychoeduaction	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)
Control	Group general fitness training	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)
Virtual Therapeutic Garden	VRTierOne	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)

Primary Outcome Measures

Name	Time	Method
The Geriatric Depression Scale (GDS)(Change from baseline)	15 minutes	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

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)(Change from baseline)	30 minutes	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.

Trial Locations

Locations (2)

University School of Physical Education; 🇵🇱 Wroclaw, Lower Silesia, Poland

Foundation for Senior Citizen Activation SIWY DYM; 🇵🇱 Wrocław, Lower Silesia, Poland