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
About this trial
This is an interventional basic science trial for Complex Posttraumatic Stress Disorder (cPTSD)
Eligibility Criteria
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
NCT ID
NCT02459340
First Posted
May 11, 2015
Last Updated
January 21, 2020
Sponsor
Yolanda Schlumpf, PhD
Collaborators
Clienia Littenheid AG, University of Zurich
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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