NCT01870271

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

March 19, 2013

Last Update Submit

May 23, 2016

Conditions

PTSD

Keywords

PTSDchildhood sexual abusephysical abusedevelopmentally adapted cognitive processing therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Other Outcomes (1)

  • 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

Study Arms (1)

DCPT

EXPERIMENTAL

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

Interventions

Developmentally adapted cognitive processing therapyBEHAVIORAL
DCPT

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Goethe University

Frankfurt am Main, Hesse, 60486, Germany

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Regina Steil, PhD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 19, 2013

First Posted

June 6, 2013

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

October 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)