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

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ClinicalTrials.gov Identifier: NCT00481000
Recruitment Status : Unknown
Verified April 2010 by Central Institute of Mental Health, Mannheim.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2007
Last Update Posted : April 21, 2010
Sponsor:
Information provided by:
Central Institute of Mental Health, Mannheim

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Dialectical Cognitive Therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Waitlist; Treatment as usual
Behavioral: Dialectical Cognitive Therapy
Dialectical Behavior Therapy in Combination with Traumafocused CBT



Primary Outcome Measures :
  1. PTSD Symptoms (CAPS, SCID, PDS, IESR) [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. general psychopathology [ Time Frame: 1.5 years ]
  2. change of pain threshold [ Time Frame: 1.5 years ]
  3. fMRI: activity of the amygdala [ Time Frame: 6 months ]


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: April 21, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders