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

April 20, 2010 updated by: Central Institute of Mental Health, Mannheim

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
general psychopathology
Time Frame: 1.5 years
1.5 years
change of pain threshold
Time Frame: 1.5 years
1.5 years
fMRI: activity of the amygdala
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2010

Last Update Submitted That Met QC Criteria

April 20, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PASA-0230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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