Complex Posttraumatic Stress Disorder (cPTSD)ECSRNCT02459340
Emotional and Cognitive Self-regulation, an EEG Study
A study testing therapeutic treatment (inpatient and outpatient setting) in people with Complex Posttraumatic Stress Disorder (cPTSD) and Dissociative Disorder Not Otherwise Specified (DDNOS), run by Yolanda Schlumpf, PhD at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)
- What is being tested?
- therapeutic treatment (inpatient and outpatient setting)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -ability to undergo EEG measurement/psychophysiological measurement
Who cannot join
- regular substance use
- acute suicidality
- comorbid psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)
- Being tested
- therapeutic treatment (inpatient and outpatient setting)
- Medical subject headings
- Dissociative Identity Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic treatment (inpatient and outpatient setting)Other
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: therapeutic treatment (inpatient and outpatient setting) |
| healthy control group | No intervention | passive control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-related potential (ERP)
Measured: up to 6 months
power in specific frequency bands
Measured: up to 6 month
Secondary outcomes (5)
heart rate
Measured: up to 6 months
electrodermal activity
Measured: up to 6 months
executive function
working memory, Schuhfried test battery
Measured: up to 6 months
measurement of psychological symptoms
questionnaire, Brief Symptom Inventory (BSI)
Measured: up to 6 month
assessment of emotion regulation and dysregulation
questionnaire, Difficulties in Emotion Regulation Scale (DERS)
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Posttraumatic Stress Disorder (cPTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yolanda Schlumpf, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Clienia Littenheid AG, University of Zurich
- Responsible party
- Sponsor-investigator, Yolanda Schlumpf, PhD, Clienia Littenheid AG
- Investigators
- Silke Bachmann, Prof. Dr. med., Study director, Privat Clinic Clienia LittenheidYolanda Schlumpf, PhD, Principal investigator, Privat Clinic Clienia Littenheid, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459340
- Sponsor's protocol ID
- CLUZH-1
- Acronym
- ECSR
- Status last verified
- Jan 2020
- First submitted
- 11 May 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35966482Schlumpf 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.
PubMed 34105902
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder and Dissociative Disorder
- ClinicalTrials.gov ID
- NCT02459340
- Acronym / sponsor ID
- ECSR / CLUZH-1
- Conditions
- Complex Posttraumatic Stress Disorder (cPTSD), Dissociative Disorder Not Otherwise Specified (DDNOS), Dissociative Identity Disorder (DID)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yolanda Schlumpf, PhDUniversity, hospital or other
- Collaborators
- Clienia Littenheid AG, University of Zurich
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Other: therapeutic treatment (inpatient and outpatient setting)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) |
| healthy control group | No intervention | –passive control group |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -ability to undergo EEG measurement/psychophysiological measurement
Key exclusion criteria (3 listed)
- regular substance use
- acute suicidality
- comorbid psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic treatment (inpatient and outpatient setting) | Other | patient group |
Primary outcome
event-related potential (ERP)
Time frame: up to 6 months
power in specific frequency bands
Time frame: up to 6 month
5 secondary outcomes
heart rate
Time frame: up to 6 months
electrodermal activity
Time frame: up to 6 months
executive function
Time frame: up to 6 months
measurement of psychological symptoms
Time frame: up to 6 month
assessment of emotion regulation and dysregulation
Time frame: up to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 35966482Schlumpf 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.
- Derived from this study: PubMed 34105902Schlumpf 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Bachmann, Prof. Dr. med. study director
Privat Clinic Clienia Littenheid
Yolanda Schlumpf, PhD principal investigator
Privat Clinic Clienia Littenheid, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic treatment (inpatient and outpatient setting) in people with Complex Posttraumatic Stress Disorder (cPTSD) and Dissociative Disorder Not Otherwise Specified (DDNOS), run by Yolanda Schlumpf, PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-related potential (ERP) (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.