Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse - Full Text View

Purpose

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.

Condition	Intervention	Phase
Posttraumatic Stress Disorder	Behavioral: Dialectical Cognitive Therapy	Phase II

MedlinePlus related topics:

Child Mental Health Mental Health Post-Traumatic Stress Disorder Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe Posttraumatic Stress Disorder Following Sexual Abuse - A Randomised Controlled Trial

Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:

PTSD Symptoms (CAPS, SCID, PDS, IESR) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

general psychopathology [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
change of pain threshold [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
fMRI: activity of the amygdala [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Waitlist; Treatment as usual	Behavioral: Dialectical Cognitive Therapy Dialectical Behavior Therapy in Combination with Traumafocused CBT

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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481000

Contacts


Contact: Regina Steil, PhD	+4962117034023	regina.steil@zi-mannheim.de

Contact: Anne S Dyer, PhD	+4962117034171	anne.dyer@zi-mannheim.de

Locations


Germany
	Central Institute of Mental Health	Recruiting
	Mannheim, Germany, 68159
	Contact: Anne S Dyer, PhD +4962117034171 anne.dyer@zi-mannheim.de
	Contact: Regina Steil, PhD +4962117034023 regina.steil@zi-mannheim.de
	Sub-Investigator: Anne S Dyer, PhD
	Principal Investigator: Regina Steil, PhD

Sponsors and Collaborators

Central Institute of Mental Health, Mannheim

Investigators


Study Director:	Regina Steil, PhD	Central Institute of Mental Health

Study Chair:	Martin Bohus, PhD	Central Institute of Mental Health

Principal Investigator:	Anne S Dyer, PhD	Central Institute of Mental Health

More Information

Responsible Party:	Central Institute of Mental Health, Psychosomatic Clinic ( Prof. Dr. Martin Bohus )
Study ID Numbers:	PASA-0230
First Received:	May 31, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00481000
Health Authority:	Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:

Dialectical Cognitive Therapy

Clinical Psychology

Pain Threshold

fMRI

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Stress Disorders, Post-Traumatic

Stress

Pain

Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Central Institute of Mental Health, Mannheim
Information provided by:	Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:	NCT00481000