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

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ClinicalTrials.gov Identifier: NCT02459340
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : August 9, 2016
Sponsor:
Collaborators:
Clienia Littenheid AG
University of Zurich
Information provided by (Responsible Party):
Yolanda Schlumpf, PhD, Clienia Littenheid AG

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, dissociative disorders, or borderline personality disorder in naturalistic inpatient and outpatient settings.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder PTSD) Complex Posttraumatic Stress Disorder (cPTSD) Dissociative Disorder Not Otherwise Specified (DDNOS) Dissociative Identity Disorder (DID) Borderline Personality Disorder (BPD) Other: therapeutic treatment (inpatient and outpatient setting) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder, Dissociative Disorder, and Borderline Personality Disorder
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


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)

Outpatient setting (PTSD, cPTSD, DDNOS, DIS): Trauma-specific psychiatric as well as psychotherapeutic treatment

Inpatient setting (BPD): Patients receive Dialectic Behavioral Therapy (DBT) and Schema-Therapy, pharmacotherapy, and non-verbal therapies (music, art, occupational, and body therapy)

Other: therapeutic treatment (inpatient and outpatient setting)
No Intervention: healthy control group
passive control group



Primary Outcome Measures :
  1. event-related potential (ERP) [ Time Frame: up to 6 months ]
  2. power in specific frequency bands [ Time Frame: up to 6 month ]

Secondary Outcome Measures :
  1. heart rate [ Time Frame: up to 6 months ]
  2. electrodermal activity [ Time Frame: up to 6 months ]
  3. executive function [ Time Frame: up to 6 months ]
    working memory, Schuhfried test battery

  4. executive function [ Time Frame: up to 6 months ]
    shifting, Schuhfried test battery

  5. executive function [ Time Frame: up to 6 months ]
    inhibition, Schuhfried test battery

  6. measurement of psychological symptoms [ Time Frame: up to 6 month ]
    questionnaire, Brief Symptom Inventory (BSI)

  7. assessment of emotion regulation and dysregulation [ Time Frame: up to 6 month ]
    questionnaire, Difficulties in Emotion Regulation Scale (DERS)



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • right handedness
  • ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

  • regular substance use
  • acute suicidality
  • comorbid psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459340


Locations
Switzerland
Privat Clinic Clienia Littenheid Recruiting
Littenheid, Thurgau, Switzerland
Contact: Yolanda Schlumpf, PhD       yolanda.schlumpf@clienia.ch   
Sponsors and Collaborators
Yolanda Schlumpf, PhD
Clienia Littenheid AG
University of Zurich
Investigators
Study Director: Silke Bachmann, Prof. Dr. med. Privat Clinic Clienia Littenheid
Principal Investigator: Yolanda Schlumpf, PhD Privat Clinic Clienia Littenheid, University of Zurich

Responsible Party: Yolanda Schlumpf, PhD, PhD, Clienia Littenheid AG
ClinicalTrials.gov Identifier: NCT02459340     History of Changes
Other Study ID Numbers: CLUZH-1
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Borderline Personality Disorder
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Personality Disorders
Dissociative Disorders
Conversion Disorder
Multiple Personality Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Somatoform Disorders