Feasibility study of VR digital therapies in MDD patients
- Conditions
- Major Depressive Disorder (MDD)Depressive DisorderVR treatmentMajor Depressive Disorder
- Registration Number
- TCTR20230824007
- Lead Sponsor
- ational Center for Global Health and Medicine (NCGM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
To be included in this study, patients should (1) have 18 years of age or older; (2) be diagnosed as having depression (DSM-5) / major depressive disorder (MDD) triggered by, or independent of, infection with SARS-CoV-2; (3) receive a definite diagnosis of MDD (single episode or recurrent episodes) in a DSM-5 structured interview (SCID-5) at the start of screening and had a depressive episode duration of 8 weeks to 12 months at the start of screening; (4) have a rumination symptom score on the Ruminative Response Scale (RRS) of 42 or higher at the start of screening and baseline; (5) have not responded to one antidepressant (SSRI, SNRI, NaSSA, or TCA/non-TCA); (6) have a total HAM-D score of 13 to 17 at the start of screening and baseline; (7) be able to wear VR goggles; (8) be able to understand verbal instructions necessary for research accomplishment and to enter data using a smartphone or tablet.
Studies were excluded if patients (1) have met a diagnostic criterion for schizophrenia, schizoaffective psychosis, schizophreniform disorder, bipolar disorder, delusional disorder, persistent depressive disorder (dysthymia), personality disorder, mental retardation, or depression with psychotic features in accordance with DSM-5 in the evaluation at the start of screening; (2) primary therapeutic objective was another mental disorder (other than those mentioned in the Exclusion criteria #1) within six months prior to the start of screening or at baseline (based on a clinical judgement by the investigator at each site); (3) receiving lithium, valproic acid, carbamazepine, or lamotrigine within six months prior to the start of screening or at baseline; (4) started a new therapy for MDD treatment within four weeks prior to the start of screening; (5) have refractory depression (Stage III or higher according to the Thase and Rush scale); (6) clinically judged as having suicidal attempt during the screening period or at baseline; (7) have received electroconvulsive therapy (ECT); (8) Patients who have received magnetic stimulation therapy (rTMS herapy); (9) received a structured psychotherapy (excluding supportive therapy), such as cognitive behavior therapy, from four weeks prior to the start of screening; (10) Patients who are diagnosed with epilepsy; (11) are considered difficult to accomplish research due to their condition; (12) are difficult to wear VR goggles for reasons, such as hypersensibility, or who are difficult to properly view VR; (13) are considered ineligible by the investigator (sub-investigators).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression at week 8 of treatment Change of Total HAM-D score
- Secondary Outcome Measures
Name Time Method Depression From baseline and at week 8 of treatment each item of HAM-D score,Depression From baseline and at week 12 of treatment Change of Total HAM-D score,Rumination From baseline and at week 8 of treatment Change of Rumination symtom score (RRS),Depression symptom From baseline and at week 8 of treatment Change of Clinical Global Impression (CGI),Quality of Life From baseline and at week 8 of treatment Change of WHOQoL-BREF score,Rumination During treatment weeks Name and frequency of rumination,Adverse events During treatment weeks Record of Adverse events