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Stress system dynamics in childhood trauma-related depression

Stress system dynamics in childhood trauma-related depression - REACT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51711
Enrollment
120
Registered
2022-05-31
Start date
2023-10-13
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, mood disorder

Interventions

Participants will undergo the trier social stress test (TSST) and a placebo version of the trier social stress test (placebo-TSST).

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria: - Mastery of Dutch language - Age of >= 18 years - Willingness and ability to give written informed consent - Normal or corrected-to-normal vision Additional inclusion criteria for the patient groups (i.e., MDD+CT and MDD-CT): - Moderate to severe depression - Score >= 26 on the Inventory of Depressive Symptoms-Self Report (IDS-SR) (Rush et al., 2000) - DSM-5 diagnosis of major depression disorder (MDD), confirmed with clinical interview (MINI (Sheehan et al., 1997)) Additional inclusion criteria for the MDD+CT group: - Moderate to severe childhood trauma (CT) before the age of 18 - Score above validated cut-off for moderate to severe CT using the Childhood Trauma Questionnaire (CTQ) (Bernstein et al., 1994):

Exclusion criteria

Exclusion criteria: General exclusion criteria: - Speech impairments - Other lifetime severe psychiatric comorbidity (bipolar disorder, psychotic disorder) or current alcohol/drug dependence - Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress Disorder (ASD) - Lifetime diagnosis of borderline personality disorder (BPD) - Any acute somatic or acute endocrine disease (e.g., acute asthma) - Taking any medication known to influence endocrine systems - Chronic benzodiazepine use (and sporadic use on the days of the lab visits) - Neurological disorder - Known contraindications for MRI investigations, such as the presence of metal objects (e.g., pacemaker, arteriovenous clips) or severe claustrophobia. Additional exclusion criteria for healthy controls and MDD-CT patients: - Moderate to severe childhood trauma (CT) before the age of 18 - Score above validated cut-off for moderate to severe CT using CTQ (see cutoff scores above) Additional exclusion criteria for healthy controls: - Past or present psychiatric condition.

Design outcomes

Primary

MeasureTime frame
The main study parameters are the laboratory stress system dynamics measured by resting state brain function directly (0 - 40 minutes) and later (60-100 minutes) after the stress (TSST) or control (placebo-TSST) test.

Secondary

MeasureTime frame
Secondary study parameters are stress system dynamics measured through task-related fMRI activity and behavior, endocrine responses during stress, perceived stress and anxiety during stress, and (psycho)physiological responses, as well as daily life stress reactivity, including physiological and psychological measures, measured by ecological momentary and physiological assessment.

Countries

Netherlands

Contacts

Public ContactJ.M. Pasteuning

Amsterdam UMC

react@amsterdamumc.nl0629680803

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)