Childhood Trauma Depression Major Depressive Disorder
Conditions
Interventions
After randomization, patients that are assigned to the TFT+TAU condition will receive 6-10 sessions of trauma-focused therapy (TFT) in addition to regular depression treatment (TAU). As part of TFT, t
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age >=18 years • Score >=26 on Inventory of Depressive Symptoms Self-Report (IDS-RS; moderate to severe depression) • DSM-5 diagnosis of major depressive disorder (MDD) confirmed with the Mini International Neuropsychiatric Interview - Simplified; MINI-S for DSM-5 • Moderate to severe childhood trauma (CT): score above validated cut-off for moderate to severe CT on one or more of the following domains using the Childhood Trauma Questionnaire (CTQ): physical neglect: score >=10; emotional neglect: score >=15; sexual abuse: score >=8; physical abuse: score >=10; emotional abuse: score >=13. • Sufficient mastery of Dutch language • Patient is inclined to participate in a randomization process • Patient in inclined to give written informed consent
Exclusion criteria
Exclusion criteria: • Previous trauma-focused therapy on childhood trauma • Other lifetime severe psychiatric comorbidity (psychotic disorder, bipolar 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is defined as depression symptom severity after 12 weeks treatment (post-treatment), measured with the Inventory of Depressive Symptomatology - Self Rated; IDS-SR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness of TAU + TFT compared to TAU by looking at: 1) remission in CT-related depression after 12 weeks of treatment (post-treatment), 2) depression symptom severity during the 12 week treatment, 3) depression symptom severity and remission after 6 weeks of treatment, and 4) depression symptom severity and remission at 6 months post-treatment (follow-up) 2. Other clinical outcomes related to TFT response: anxiety, disability, insomnia, subjective stress and suicidal ideation and behavior 3. Descriptive variables (clinical factors and previous and current care), and potential moderators and mediators related to TFT response 4. Stress-related biomarkers (to better understand how and for who TFT works): • Hair cortisol levels: at baseline and post-treatment. • Blood: at baseline and post-treatment for research on inflammatory and (epi)genetic markers in relation to TFT response. fMRI substudy In a subgroup of 60 participants (matched for treatment allocation, age, and sex), stress-related brain activity is measured with a +/- 60 minute fMRI assessment before treatment and after 12 weeks of treatment, to better understand the brain mechanisms of trauma-focused psychotherapy. | — |
Countries
Netherlands
Contacts
Public ContactA.W. Gathier
Amsterdam UMC
Outcome results
None listed