REStoring mood after Early life Trauma - the effectiveness of trauma-focused therapy in patients with depression and childhood trauma

Recruiting

• Conditions: Childhood Trauma; Depression; Major Depressive Disorder; 10027946

• Registration Number: NL-OMON54461
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 158

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is defined as depression symptom severity after 12<br /><br>weeks treatment (post-treatment), measured with the Inventory of Depressive<br /><br>Symptomatology - Self Rated; IDS-SR. </p><br>