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

NCT06433843 | Completed DMC

• 1 other identifier: 090/2015BO2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• DNA methylation levels of FKBP5 before and following DBT-PTSD

  FK506 binding protein 5 (FKBP5), an immunoregulator modulating glucocorticoid receptor activity, plays a key role in stress reactivity

  After 12 weeks of DBT-PTSD treatment

Study Arms (1)

cPTSD patients participating in 12-weeks DBT-PTSD program

OTHER

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)

Behavioral: Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)

Interventions

Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD) BEHAVIORAL

12 weeks inpatient disorder specific psychotherapy

cPTSD patients participating in 12-weeks DBT-PTSD program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute suicidality

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)