REStoring Mood After Early Life Trauma: the Effectiveness of Trauma-focused Therapy in Patients With Depression and Childhood Trauma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 158
- Locations
- 3
- Primary Endpoint
- Depressive symptom severity at post-treatment
Study Overview
Brief Summary
Depression is a debilitating psychiatric disorder with a recurrent and progressive course. Around 25% of depressive patients has experienced moderate to severe levels of childhood trauma (CT), resulting in earlier onset and more severe and recurrent depressions. There is currently no targeted treatment for CT-related depression. This is problematic as patients with CT-related depression respond poorly to standard depression treatments. The RESET-psychotherapy study proposes an innovative, targeted disease-modifying treatment strategy for CT-related depression. The main objective is to investigate the effectiveness of trauma-focused therapy (TFT), as an addition to regular depression treatment ('treatment as usual'; TAU), in reducing depression symptom severity in patients with CT-related depression. 158 adult patients will be randomized to receive a 12-week treatment with 1) TAU or 2) TFT in combination with TAU. 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).
Detailed Description
Depression is a debilitating psychiatric disorder with a recurrent and progressive course. Even though antidepressants and psychotherapy are often effective, a substantial proportion of patients does not respond to currently used evidence-based treatments. Around 25% of depressive patients has experienced moderate to severe levels of childhood trauma (CT), ranging from physical and emotional neglect to emotional, physical and sexual abuse. There is increasing evidence that depression related to childhood trauma (CT) is critically different from non-CT related depression: it emerges earlier in life with more severe and recurrent symptoms and has worse treatment outcomes. Therefore, there is a large and unmet need for novel therapeutic strategies for CT-related depression. Currently, there is no targeted treatment available for CT-related depression. Given the major role of trauma in CT-related depression, it is plausible that trauma-focused psychotherapies may be effective in this depression subtype. The current study aims to investigate the effectiveness of trauma-focused therapy (TFT), as an addition to 'treatment as usual' (TAU), in reducing depression symptom severity in patients with CT-related depression. It is expected that trauma-focused therapy will be a safe and rational strategy to enhance resilience and improve depression outcomes for patients with CT-related depression. RESET-psychotherapy is a 12-week randomized controlled clinical trial (single-blind RCT), in which TFT in combination with TAU will be compared to TAU only at various specialized mental healthcare units of mental health care institutions. The study population will consist of 158 adult patients who have a diagnosis of moderate to severe depression (according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) and moderate to severe childhood trauma (CT). 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). Data will be collected during multiple assessments: at baseline (T0), after 6 weeks (T1), after 12 weeks (T2; post-treatment), and after 6 months post-treatment (follow-up, T3). Information about depressive symptoms, childhood trauma and other health-related outcomes will be assessed using self-report questionnaires and semi-structured clinical interviews. In addition, to better understand how and for who TFT works, stress-related biomarkers (hair cortisol, inflammatory and epigenetic biomarkers in the blood) will be examined pre- and post-treatment. A sub-group of patients (N=60, 30 per intervention group) will be asked to undergo fMRI scans pre- and post-treatment to measure stress-related brain activity (fMRI sub-study, ±60 minutes per fMRI session).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
As the interventions in these studies are psychotherapies, both participants and care providers cannot be masked from the treatment allocation. To ensure the objectivity of the research measures, the outcome assessors will be blinded to the allocated treatment condition.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Moderate to severe depression, defined by a score ≥ 26 on the Inventory of Depressive Symptomatology - Self Rated (IDS-SR)
- •DSM-5 diagnosis of MDD confirmed with the Dutch translation of the MINI-S for DSM-5
- •Moderate to severe childhood trauma (CT) before the age of 18, defined by a score above validated cut-off on one or more of the following domains of the 28-item Childhood Trauma Questionnaire Short Form (CTQ-SF):
- •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
Exclusion Criteria
- •Previous TFT on CT
- •Other lifetime severe psychiatric comorbidity (bipolar disorder, psychotic disorder)
- •Current alcohol/drug dependence
- •Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress Disorder (ASD)
- •Lifetime diagnosis of borderline personality disorder (BPD)
Arms & Interventions
Treatment as usual (TAU)
Participants will receive an evidence-based psychotherapeutic intervention combined with/or pharmacotherapy (TAU)
Intervention: Treatment as usual (TAU) for depression (Behavioral)
Treatment as usual (TAU) + Trauma-focused therapy (TFT)
Participants will receive 6 to 10, 60-90 minute TFT sessions delivered over a period of 12 weeks, in addition to TAU.
Intervention: Treatment as usual (TAU) for depression (Behavioral)
Treatment as usual (TAU) + Trauma-focused therapy (TFT)
Participants will receive 6 to 10, 60-90 minute TFT sessions delivered over a period of 12 weeks, in addition to TAU.
Intervention: Trauma-focused therapy (TFT) (Behavioral)
Outcomes
Primary Outcomes
Depressive symptom severity at post-treatment
Time Frame: Up to 12 weeks (post-treatment)
Depressive symptom severity in patients with CT-related depression, measured with the Inventory of Depressive Symptomatology - Self Report (IDS-SR, with a total score ranging from 0 to 84, where higher scores indicate higher severity of depressive symptoms)
Secondary Outcomes
- Depressive symptom severity during treatment and at 9 months follow-up(Up to 9 months (follow-up))
- Remission in CT-related depression(Up to 9 monts (follow-up))
Investigators
Christiaan Vinkers
Prof. dr. mr. C.H. Vinkers
Amsterdam UMC, location VUmc