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Emotional and Cognitive Self-regulation, an EEG Study (ECSR)

Primary Purpose

Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
therapeutic treatment (inpatient and outpatient setting)
Sponsored by
Yolanda Schlumpf, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Complex Posttraumatic Stress Disorder (cPTSD)

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

  • regular substance use
  • acute suicidality
  • comorbid psychosis

Sites / Locations

  • Privat Clinic Clienia Littenheid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patient group

healthy control group

Arm Description

Inpatient setting (cPTSD, DDNOS, DIS): Trauma-adapted psychotherapy (individual and group setting), body-related, cognitive stabilization groups, pharmacotherapy, and other non-verbal treatment modalities (e.g. music, art, and occupational therapy)

passive control group

Outcomes

Primary Outcome Measures

event-related potential (ERP)
power in specific frequency bands

Secondary Outcome Measures

heart rate
electrodermal activity
executive function
working memory, Schuhfried test battery
measurement of psychological symptoms
questionnaire, Brief Symptom Inventory (BSI)
assessment of emotion regulation and dysregulation
questionnaire, Difficulties in Emotion Regulation Scale (DERS)

Full Information

First Posted
May 11, 2015
Last Updated
January 21, 2020
Sponsor
Yolanda Schlumpf, PhD
Collaborators
Clienia Littenheid AG, University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02459340
Brief Title
Emotional and Cognitive Self-regulation, an EEG Study
Acronym
ECSR
Official Title
Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder and Dissociative Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yolanda Schlumpf, PhD
Collaborators
Clienia Littenheid AG, University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main goal of the proposed project is to assess treatment-induced changes of electrophysiological and psychophysiological correlates of the capacity to regulate emotion, executive functions, and clinical measures in individuals with complex posttraumatic stress disorder and dissociative disorders in a naturalistic inpatient setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient group
Arm Type
Experimental
Arm Description
Inpatient setting (cPTSD, DDNOS, DIS): Trauma-adapted psychotherapy (individual and group setting), body-related, cognitive stabilization groups, pharmacotherapy, and other non-verbal treatment modalities (e.g. music, art, and occupational therapy)
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
passive control group
Intervention Type
Other
Intervention Name(s)
therapeutic treatment (inpatient and outpatient setting)
Primary Outcome Measure Information:
Title
event-related potential (ERP)
Time Frame
up to 6 months
Title
power in specific frequency bands
Time Frame
up to 6 month
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
up to 6 months
Title
electrodermal activity
Time Frame
up to 6 months
Title
executive function
Description
working memory, Schuhfried test battery
Time Frame
up to 6 months
Title
measurement of psychological symptoms
Description
questionnaire, Brief Symptom Inventory (BSI)
Time Frame
up to 6 month
Title
assessment of emotion regulation and dysregulation
Description
questionnaire, Difficulties in Emotion Regulation Scale (DERS)
Time Frame
up to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -ability to undergo EEG measurement/psychophysiological measurement Exclusion Criteria: regular substance use acute suicidality comorbid psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silke Bachmann, Prof. Dr. med.
Organizational Affiliation
Privat Clinic Clienia Littenheid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yolanda Schlumpf, PhD
Organizational Affiliation
Privat Clinic Clienia Littenheid, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Privat Clinic Clienia Littenheid
City
Littenheid
State/Province
Thurgau
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35966482
Citation
Schlumpf YR, Nijenhuis ERS, Klein C, Jancke L, Bachmann S. Functional connectivity changes in the delta frequency band following trauma treatment in complex trauma and dissociative disorder patients. Front Psychiatry. 2022 Jul 25;13:889560. doi: 10.3389/fpsyt.2022.889560. eCollection 2022.
Results Reference
derived
PubMed Identifier
34105902
Citation
Schlumpf YR, Nijenhuis ERS, Klein C, Jancke L, Bachmann S. Resting-state functional connectivity in patients with a complex PTSD or complex dissociative disorder before and after inpatient trauma treatment. Brain Behav. 2021 Jul;11(7):e02200. doi: 10.1002/brb3.2200. Epub 2021 Jun 9.
Results Reference
derived

Learn more about this trial

Emotional and Cognitive Self-regulation, an EEG Study

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