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

Posttraumatic Stress Disorder Clinical Trial

— PASA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00481000
• Other study ID #: PASA-0230
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 31, 2007
• Last updated: April 20, 2010
• Start date: April 2007
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: October 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Dialectical Cognitive Therapy
Dialectical Behavior Therapy in Combination with Traumafocused CBT

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptoms (CAPS, SCID, PDS, IESR)		1.5 years	No
Secondary	general psychopathology		1.5 years	No
Secondary	change of pain threshold		1.5 years	No
Secondary	fMRI: activity of the amygdala		6 months	No