Pilot-Study DCPT for PTSD in Adolescents and Young Adults (Pilot-DCPT)

May 23, 2016 updated by: Regina Steil, Goethe University

Pilotstudie Developmentally Adapted Cognitive Processing Therapy für Jugendliche Und Junge Erwachsene Mit Posttraumatischer Belastungsstörung Nach Sexualisierter Und /Oder körperlicher Gewalt (Pilot DCPT)

The aim of this pilot study is to evaluate the developmentally adapted cognitive processing therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA) related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI), Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this pilot study is to evaluate the developmentally adapted cognitive processing therapy (D-CPT)in adolescents suffering from childhood sexual abuse (CA) or childhood physical abuse (PA) related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering from CA or PA-related PTSD in a multicenter study in Berlin, Frankfurt and Ingolstadt in Germany (3 sites).Patients will be assessed prior to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI), Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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
    • Hessen
      • Frankfurt, Hessen, Germany, 60486
        • Department of Clinical Psychology and Psychotherapy, Goethe University

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

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PTSD after CSA and/or CPA beyond the age of three (confirmed by a structured clinical interview, CAPS-CA, German Version IBS-KJ)
  • PTSD must be the primary diagnosis (most severe disorder according to SCID)
  • age 14 - 21 years
  • living in safe conditions
  • informed consent from parents/legal guardians (if under 18) and participant

Exclusion Criteria:

  • current psychotic
  • substance related or organic mental disorder
  • acute suicidality, severe medical conditions
  • mental retardation
  • insufficient knowledge of German language.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCPT
Treatment with developmentally adapted D-CPT. 30 to 36 individual treatment sessions. Treatment sections comprise a commitment phase (5 sessions), emotion regulation phase (6 sessions), CPT (15 sessions) and a final phase targeting developmentally-related challenges (4 sessions).
Behavioral: Developmentally adapted cognitive processing therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician-Administered PTSD-Scale for Children and Adolescents
Time Frame: t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
UCLA PTSD Index (UCLA)
Time Frame: t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
Beck Depression Inventory
Time Frame: t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up

Other Outcome Measures

Outcome Measure
Time Frame
Borderline Symptom List (BSL-23)
Time Frame: t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up

Collaborators and Investigators

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

Sponsor

Goethe University

Collaborators

Katholische Universität Eichstätt Ingolstadt
Freie Universität Berlin

Investigators

  • Principal Investigator: Regina Steil, PhD, Goethe University

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

November 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pilot-DCPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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