depression, Depressive disorder Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of a depressive disorder according to the DSM-V diagnosed by the MINI: MDD, PDD or unspecified depressive disorder; 2. Participants have an IDS-SR score at baseline of >= 18; 3. Participants are recruited as new referrals or during intake at the UCP, including patients who will participate in the once-weekly and thrice-weekly group programs and patients receiving individual outpatient sessions; 4. Age 18-64.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to the TSST (in vivo or VR version); 2. Photosensitive epilepsy or organic brain damage; 3. Insufficient command of the Dutch language; 4. Intellectual disability (estimated IQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary baseline parameters (T0) include physiological stress response as measured by heart rate variability (HRV) in the frequency and time domains, salivary cortisol (CRT) and electrodermal activity (EDA) in response to a psychosocial stressor (TSST-VR); and psychological stress response as measured by the State-Trait Anxiety Inventory - short form (STAI-6). The primary endpoint is change in depression symptom severity measured by the Inventory of Depressive Symptomatology (IDS-SR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes include anxiety symptom severity measured by the Beck Anxiety Inventory (BAI) and psychosocial functioning measured by the Interpersonal Relationships and Social Role subscales of the Outcome Questionnaire (OQ-45). Other study parameters include real-life stress response measured with EMA and wearable sensors, and potential factors moderating the relationship between stress response and depressive symptoms (family history of depression, stressful life events, personality traits and coping styles). Secondary parameters are described in more detail in the research protocol. | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Groningen