FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome

Not Applicable

Completed

• Conditions: Borderline Personality Disorder; Posttraumatic Stress Disorder
• Interventions: Behavioral: Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)

• Registration Number: NCT06433843
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD.

Detailed Description

Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program.

29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment

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Exclusion Criteria

Acute suicidality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cPTSD patients participating in 12-weeks DBT-PTSD program	Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)	The study consists of one arm including cPTSD patients, who participated in a 12-weeks dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)

Primary Outcome Measures

Name	Time	Method
DNA methylation levels of FKBP5 before and following DBT-PTSD	After 12 weeks of DBT-PTSD treatment	FK506 binding protein 5 (FKBP5), an immunoregulator modulating glucocorticoid receptor activity, plays a key role in stress reactivity

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden Württemberg, Germany