PTSDPilot-DCPTNCT01870271
Pilot-Study DCPT for PTSD in Adolescents and Young Adults
A study testing Developmentally adapted cognitive processing therapy in people with PTSD, run by Goethe University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- PTSD
- What is being tested?
- Developmentally adapted cognitive processing therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- current psychotic
- substance related or organic mental disorder
- acute suicidality, severe medical conditions
- mental retardation
- insufficient knowledge of German language.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Goethe University
Frankfurt am Main, Hesse, 60486
About this study
Official title: 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).
Read the 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).
- Conditions
- PTSD
- Being tested
- Developmentally adapted cognitive processing therapy
- Keywords
- PTSD, childhood sexual abuse, physical abuse, developmentally adapted cognitive processing therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmentally adapted cognitive processing therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Developmentally adapted cognitive processing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD-Scale for Children and Adolescents
Measured: 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)
Measured: 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
Measured: t0=pretreatment (baseline), t1= change from baseline at post-treatment after 20 weeks t2= change from posttreatment at 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Katholische Universität Eichstätt Ingolstadt, Freie Universität Berlin
- Responsible party
- Principal investigator, Regina Steil, Goethe University
- Investigators
- Regina Steil, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870271
- Sponsor's protocol ID
- Pilot-DCPT
- Acronym
- Pilot-DCPT
- Status last verified
- May 2016
- First submitted
- 19 Mar 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotstudie Developmentally Adapted Cognitive Processing Therapy für Jugendliche Und Junge Erwachsene Mit Posttraumatischer Belastungsstörung Nach Sexualisierter Und /Oder körperlicher Gewalt (Pilot DCPT)
- ClinicalTrials.gov ID
- NCT01870271
- Acronym / sponsor ID
- Pilot-DCPT / Pilot-DCPT
- Conditions
- PTSD
- Keywords
- PTSD, childhood sexual abuse, physical abuse, developmentally adapted cognitive processing therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Katholische Universität Eichstätt Ingolstadt, Freie Universität Berlin
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCPT | Experimental | Behavioral: Developmentally adapted cognitive processing therapyTreatment 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). |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- current psychotic
- substance related or organic mental disorder
- acute suicidality, severe medical conditions
- mental retardation
- insufficient knowledge of German language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developmentally adapted cognitive processing therapy | Behavioural | DCPT |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Steil, PhD principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developmentally adapted cognitive processing therapy in people with PTSD, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.