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

Primary Purpose

Posttraumatic Stress Disorder

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Dialectical Cognitive Therapy

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Dialectical Cognitive Therapy, Clinical Psychology

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Central Institute of Mental Health

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Arm Description

Waitlist; Treatment as usual

Outcomes

Primary Outcome Measures

PTSD Symptoms (CAPS, SCID, PDS, IESR)

Secondary Outcome Measures

general psychopathology

change of pain threshold

fMRI: activity of the amygdala

Full Information

NCT ID

NCT00481000

First Posted

May 31, 2007

Last Updated

April 20, 2010

Sponsor

Central Institute of Mental Health, Mannheim

1. Study Identification

Unique Protocol Identification Number

NCT00481000

Brief Title

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

Acronym

PASA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Central Institute of Mental Health, Mannheim

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

Dialectical Cognitive Therapy, Clinical Psychology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Waitlist; Treatment as usual

Intervention Type

Behavioral

Intervention Name(s)

Dialectical Cognitive Therapy

Intervention Description

Dialectical Behavior Therapy in Combination with Traumafocused CBT

Primary Outcome Measure Information:

Title

PTSD Symptoms (CAPS, SCID, PDS, IESR)

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

general psychopathology

Time Frame

1.5 years

Title

change of pain threshold

Time Frame

1.5 years

Title

fMRI: activity of the amygdala

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Regina Steil, PhD

Organizational Affiliation

Central Institute of Mental Health

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Martin Bohus, PhD

Organizational Affiliation

Central Institute of Mental Health

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anne S Dyer, PhD

Organizational Affiliation

Central Institute of Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Institute of Mental Health

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

32368793

Citation

Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

Results Reference

derived

PubMed Identifier

28717512

Citation

Gorg N, Priebe K, Bohnke JR, Steil R, Dyer AS, Kleindienst N. Trauma-related emotions and radical acceptance in dialectical behavior therapy for posttraumatic stress disorder after childhood sexual abuse. Borderline Personal Disord Emot Dysregul. 2017 Jul 13;4:15. doi: 10.1186/s40479-017-0065-5. eCollection 2017.

Results Reference

derived

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

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