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

January 21, 2020 updated by: Yolanda Schlumpf, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Thurgau
      • Littenheid, Thurgau, Switzerland
        • Privat Clinic Clienia Littenheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

  • regular substance use
  • acute suicidality
  • comorbid psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient group
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)
Other: therapeutic treatment (inpatient and outpatient setting)
No Intervention: healthy control group
passive control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
event-related potential (ERP)
Time Frame: up to 6 months
up to 6 months
power in specific frequency bands
Time Frame: up to 6 month
up to 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: up to 6 months
up to 6 months
electrodermal activity
Time Frame: up to 6 months
up to 6 months
executive function
Time Frame: up to 6 months
working memory, Schuhfried test battery
up to 6 months
measurement of psychological symptoms
Time Frame: up to 6 month
questionnaire, Brief Symptom Inventory (BSI)
up to 6 month
assessment of emotion regulation and dysregulation
Time Frame: up to 6 month
questionnaire, Difficulties in Emotion Regulation Scale (DERS)
up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yolanda Schlumpf, PhD

Collaborators

University of Zurich
Clienia Littenheid AG

Investigators

  • Study Director: Silke Bachmann, Prof. Dr. med., Privat Clinic Clienia Littenheid
  • Principal Investigator: Yolanda Schlumpf, PhD, Privat Clinic Clienia Littenheid, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLUZH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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