NCT02459340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

May 11, 2015

Last Update Submit

January 21, 2020

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • event-related potential (ERP)

    up to 6 months

  • power in specific frequency bands

    up to 6 month

Secondary Outcomes (5)

  • heart rate

    up to 6 months

  • electrodermal activity

    up to 6 months

  • executive function

    up to 6 months

  • measurement of psychological symptoms

    up to 6 month

  • assessment of emotion regulation and dysregulation

    up to 6 month

Study Arms (2)

patient group

EXPERIMENTAL

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)

healthy control group

NO INTERVENTION

passive control group

Interventions

therapeutic treatment (inpatient and outpatient setting)OTHER
patient group

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ability to undergo EEG measurement/psychophysiological measurement

You may not qualify if:

  • regular substance use
  • acute suicidality
  • comorbid psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Privat Clinic Clienia Littenheid

Littenheid, Thurgau, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 35966482DERIVED

  • 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.

    PMID: 34105902DERIVED

MeSH Terms

Conditions

Dissociative Identity Disorder

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Dissociative DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Inosine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Silke Bachmann, Prof. Dr. med.

    Privat Clinic Clienia Littenheid

    STUDY DIRECTOR

  • Yolanda Schlumpf, PhD

    Privat Clinic Clienia Littenheid, University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 11, 2015

First Posted

June 2, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

CH(1)