Dialectical Cognitive Traumatherapy (DCT) on Patients Wit... | NCT00481000

Studies
Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse

NCT00481000

Sponsor

Central Institute of Mental Health, Mannheim

Status

Unknown status

Last Update Posted

Apr 21, 2010Estimated

Enrollment

64Estimated

Phase

Phase 2

Conditions

Posttraumatic Stress Disorder

Interventions

Dialectical Cognitive Therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Dec 2008Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

May 31, 2007

First Submission Date that Met QC Criteria

May 31, 2007

First Posted Date

Jun 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2010

Last Update Posted Date

Apr 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether Dialectical Cognitive Traumatherapy is effective in the treatment of severe and chronic Posttraumatic Stress Disorder (PTSD) following childhood sexual abuse.

Detailed Description

Most studies on psychological treatments for PTSD exclude patients with severe, co-occurring psychopathology. We designed a new treatment (Dialectical Cognitive Trauma Therapy, or DCT) specifically to treat these patients. DCT includes elements of emotion regulation, mindfulness exercises, cognitive and exposure treatment, as well as new elements. This randomized controlled study evaluates the effect of inpatient DCT on these patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Waitlist; Treatment as usual	Behavioral: Dialectical Cognitive Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dialectical Cognitive Therapy	Behavioral	Dialectical Behavior Therapy in Combination with Traumafocused CBT	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD Symptoms (CAPS, SCID, PDS, IESR)		1.5 years

Secondary Outcomes

Measure	Description	Time Frame
general psychopathology		1.5 years
change of pain threshold		1.5 years
fMRI: activity of the amygdala

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Minimum age of 17
Childhood sexual abuse
Posttraumatic Stress Disorder (criteria of SCID)
At least one of the following diagnoses: Anorexia Nervosa, or Bulimia Nervosa, or substance abuse, or substance dependence, or major depression or at least 4 out of 9 criteria for Borderline Personality Disorder

Exclusion Criteria:

Diagnosis of schizophrenia
Mental retardation
Body Mass Index lower than 16.5
Acute delirium
Perilous selfharming behaviour during the last 4 month
Suicide attempt with the distinct intention to die during the last 4 month
Unstability (e.g. homelessness, acute victimisation by offender)
Pretreatment by DCT

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Regina Steil, PhD	Central Institute of Mental Health	Study Director
Martin Bohus, PhD	Central Institute of Mental Health	Study Chair
Anne S Dyer, PhD	Central Institute of Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Institute of Mental Health		Mannheim		68159	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32368793	Derived	Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
28717512

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders