Clinical trial NCT00481000: Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe PTSD Following Sexual Abuse
Official title: Dialectical Cognitive Traumatherapy (DCT) on Patients With Severe Posttraumatic Stress Disorder Following Sexual Abuse - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: Dialectical Cognitive Therapy
Clinical Psychology
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD Symptoms (CAPS, SCID, PDS, IESR)
timeFrame: 1.5 years
Secondary outcomes:
measure: general psychopathology
timeFrame: 1.5 years
measure: change of pain threshold
timeFrame: 1.5 years
measure: fMRI: activity of the amygdala
timeFrame: 6 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Central Institute of Mental Health
name: Regina Steil, PhD
role: STUDY_DIRECTOR
affiliation: Central Institute of Mental Health
name: Martin Bohus, PhD
role: STUDY_CHAIR
affiliation: Central Institute of Mental Health
name: Anne S Dyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.