Emotional and Cognitive Self-regulation, an EEG Study

Complex Posttraumatic Stress Disorder (cPTSD) Clinical Trial

— ECSR  

Official title:

Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder and Dissociative Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459340
• Other study ID #: CLUZH-1
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2020
• Source: Clienia Littenheid AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

-ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

• regular substance use

• acute suicidality

• comorbid psychosis

Related Conditions & MeSH terms

• Complex Posttraumatic Stress Disorder (cPTSD)
• Conversion Disorder
• Disease
• Dissociative Disorder Not Otherwise Specified (DDNOS)
• Dissociative Disorders
• Dissociative Identity Disorder
• Dissociative Identity Disorder (DID)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• therapeutic treatment (inpatient and outpatient setting)

Locations

Country	Name	City	State
Switzerland	Privat Clinic Clienia Littenheid	Littenheid	Thurgau

Sponsors (3)

Lead Sponsor	Collaborator
Yolanda Schlumpf, PhD	Clienia Littenheid AG, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-related potential (ERP)		up to 6 months
Primary	power in specific frequency bands		up to 6 month
Secondary	heart rate		up to 6 months
Secondary	electrodermal activity		up to 6 months
Secondary	executive function	working memory, Schuhfried test battery	up to 6 months
Secondary	measurement of psychological symptoms	questionnaire, Brief Symptom Inventory (BSI)	up to 6 month
Secondary	assessment of emotion regulation and dysregulation	questionnaire, Difficulties in Emotion Regulation Scale (DERS)	up to 6 month