NCT00481000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

1.7 years

First QC Date

May 31, 2007

Last Update Submit

April 20, 2010

Conditions

Keywords

Dialectical Cognitive TherapyClinical Psychology

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptoms (CAPS, SCID, PDS, IESR)

    1.5 years

Secondary Outcomes (3)

  • general psychopathology

    1.5 years

  • change of pain threshold

    1.5 years

  • fMRI: activity of the amygdala

    6 months

Study Arms (1)

1

NO INTERVENTION

Waitlist; Treatment as usual

Behavioral: Dialectical Cognitive Therapy

Interventions

Dialectical Behavior Therapy in Combination with Traumafocused CBT

1

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Regina Steil, PhD

    Central Institute of Mental Health

    STUDY DIRECTOR
  • Martin Bohus, PhD

    Central Institute of Mental Health

    STUDY CHAIR
  • Anne S Dyer, PhD

    Central Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

October 1, 2010

Last Updated

April 21, 2010

Record last verified: 2010-04

Locations