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Clinical Trials/NCT04047511
NCT04047511CompletedNot Applicable

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

Wroclaw University of Health and Sport Sciences2 sites in 1 country23 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
23
Locations
2
Primary Endpoint
The Geriatric Depression Scale (GDS)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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;

Outcomes

Primary Outcomes

The Geriatric Depression Scale (GDS)

Time Frame: 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 Outcomes

  • Hospital Anxiety and Depression Scale (HADS)(30 minutes)
  • Perception of Stress Questionnaire (PSQ)(30 minutes)

Investigators

Sponsor
Wroclaw University of Health and Sport Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Błażej Cieślik

Research Assistant

Wroclaw University of Health and Sport Sciences

Study Sites (2)

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