Pilot-Study DCPT for PTSD in Adolescents and Young Adults

PTSD Clinical Trial

— Pilot-DCPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870271
• Other study ID #: Pilot-DCPT
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: May 23, 2016
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Developmentally adapted cognitive processing therapy

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Goethe University	Frankfurt	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
Goethe University	Freie Universität Berlin, Katholische Universität Eichstätt Ingolstadt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Borderline Symptom List (BSL-23)		t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up	No
Primary	Clinician-Administered PTSD-Scale for Children and Adolescents		t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up	No
Secondary	UCLA PTSD Index (UCLA)		t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up	No
Secondary	Beck Depression Inventory		t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up	No