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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Central Institute of Mental Health, Mannheim.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00481000
First received: May 31, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe Posttraumatic Stress Disorder Following Sexual Abuse - A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: 1
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

Locations
Germany
Central Institute of Mental Health
Mannheim, Germany, 68159
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

No publications provided

Responsible Party: Prof. Dr. Martin Bohus, Central Institute of Mental Health, Psychosomatic Clinic
ClinicalTrials.gov Identifier: NCT00481000     History of Changes
Other Study ID Numbers: PASA-0230
Study First Received: May 31, 2007
Last Updated: April 20, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:
Dialectical Cognitive Therapy
Clinical Psychology

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013