## Protocol Section
### Identification Module
**NCT ID:** NCT06433843

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

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

#### Organization Study ID Info
**ID:** 090/2015BO2
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Tuebingen
### Status Module
#### Completion Date
**Date:** 2020-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Tuebingen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Borderline Personality Disorder

- Posttraumatic Stress Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 29

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

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

**Label:** cPTSD patients participating in 12-weeks DBT-PTSD program

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cPTSD patients participating in 12-weeks DBT-PTSD program

**Description:** 12 weeks inpatient disorder specific psychotherapy

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

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** DNA methylation levels of FKBP5 before and following DBT-PTSD

**Time Frame:** After 12 weeks of DBT-PTSD treatment

### Eligibility Module

**Eligibility Criteria:** 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

Exclusion Criteria:

Acute suicidality

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tuebingen

**Country:** Germany

**Facility:** University Hospital Tuebingen

**State:** Baden Württemberg

**Zip:** 72076

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Stress Disorder

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Posttraumatic Stress Disorder

- ID: M13462

- Name: Personality Disorders

- Relevance: HIGH

- As Found: Personality Disorder

- ID: M5161

- Name: Borderline Personality Disorder

- Relevance: HIGH

- As Found: Borderline Personality Disorder

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

- ID: D000010554

- Term: Personality Disorders

- ID: D000001883

- Term: Borderline Personality Disorder

### Misc Info Module

- Version Holder: 2024-05-31
