Clinical trial NCT05285501: Virtual Therapeutic Garden for Depressive Symptoms
Official title: Immersive Virtual Therapeutic Garden as a Support for Late-Life Depressive Symptoms: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Depression
Anxiety
Keywords: virtual reality
depression
anxiety
mental health
elderly
rehabilitation
virtual garden
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Foundation for Senior Citizen Activation SIWY DYM
First posted: 2022-03-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: The Geriatric Depression Scale (GDS)(Change from baseline)
timeFrame: 15 minutes
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)(Change from baseline)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: University School of Physical Education
state: Lower Silesia
city: Wrocław
country: Poland
facility: Foundation for Senior Citizen Activation SIWY DYM
state: Lower Silesia
Study officials:
affiliation: University School of Physical Education, Wroclaw, Poland
name: Joanna Szczepańska-Gieracha, Professor
role: STUDY_DIRECTOR
affiliation: Jan Dlugosz University in Czestochowa, Poland
name: Błażej Ł Cieślik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cieslik B, Mazurek J, Rutkowski S, Kiper P, Turolla A, Szczepanska-Gieracha J. Virtual reality in psychiatric disorders: A systematic review of reviews. Complement Ther Med. 2020 Aug;52:102480. doi: 10.1016/j.ctim.2020.102480. Epub 2020 Jun 9.
citation: Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.
citation: Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.
citation: Szczepanska-Gieracha J, Cieslik B, Serweta A, Klajs K. Virtual Therapeutic Garden: A Promising Method Supporting the Treatment of Depressive Symptoms in Late-Life: A Randomized Pilot Study. J Clin Med. 2021 May 1;10(9):1942. doi: 10.3390/jcm10091942.
citation: Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.
citation: Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.