PTSDTF-CBTNCT05248971
Implementation of Truma-Focused Cognitive Behavioral Therapy (TF-CBT) in Norway
An observational study of PTSD, run by Norwegian Center for Violence and Traumatic Stress Studies.
Trial summary
Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method for children and adolescents who have been exposed to traumatic experiences and who are experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child and adolescent mental health clinics since 2012. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- PTSD
- What is being tested?
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- How many people
- 26,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2021
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 6-18 referred to Norwegian child and adolescent mental health clinics.
Who may be able to join
- 6-18 years
- Referred to Norwegian child and adolescent mental health clinics
Who cannot join
- Below 6 years and above 18 years
About this study
Official title: Implementation of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in Norwegian Child and Adolescent Mental Health Clinics
Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method for children and adolescents who have been exposed to traumatic experiences and who are experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child and adolescent mental health clinics since 2012. The Ministry of Health is funding the implementation project, and the Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the implementation, including training of therapists, quality monitoring, and research.
Read the detailed description
All participating child and adolescent mental health clinics received training by TF-CBT senior trainers at NKVTS in screening for trauma exposure and posttraumatic stress. A sub-sample of the therapists received training in TF-CBT. Data are collected on treatment outcomes for quality assurance.
- Conditions
- PTSD
- Being tested
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- Keywords
- PTSD, Trauma treatment, Implementation
- 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.
Trauma-focused cognitive behavioral therapy (TF-CBT)Other
TF-CBT is an evidence-based treatment method for children and adolescents who have been exposed to trauma and experience posttraumatic stress symptoms. The treatment model has a family and caregiver focus, and non-offending caregivers are included in the treatment. TF-CBT is normally provided through 8-12 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Children screened for trauma and/or posttraumatic stress | Children were screened for trauma exposure and posttraumatic stress at one of the first meetings at the child and adolescent mental health clinic. For participants receiving TF-CBT, posttraumatic stress was also assessed during and after therapy. Receives: Other: Trauma-focused cognitive behavioral therapy (TF-CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Adolescent Trauma Screen (CATS)
Consists of two parts. Part 1 is a screening for exposure to potential traumatizing events; Part 2 is a screening for posstraumatic stress symptoms
Measured: 2012-2014
Child PTSD Symptom Scale (CPSS)
Consists of two parts. Part 1 is a screening for exposure to potential traumatizing events; Part 2 is a screening for posstraumatic stress symptoms
Measured: 2015-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 26,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ane-Marthe Solheim Skar, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Ane-Marthe S Skar, PhD, Principal investigator, Norwegian Center for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248971
- Sponsor's protocol ID
- TF-CBT 2012-2021
- Acronym
- TF-CBT
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skar AS, Braathu N, Jensen TK, Ormhaug SM. Predictors of nonresponse and drop-out among children and adolescents receiving TF-CBT: investigation of client-, therapist-, and implementation factors. BMC Health Serv Res. 2022 Sep 29;22(1):1212. doi: 10.1186/s12913-022-08497-y.
PubMed 36175864
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in Norwegian Child and Adolescent Mental Health Clinics
- ClinicalTrials.gov ID
- NCT05248971
- Acronym / sponsor ID
- TF-CBT / TF-CBT 2012-2021
- Conditions
- PTSD
- Keywords
- PTSD, Trauma treatment, Implementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,500 participants (actual)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Feb 2022 (actual)
- 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.
Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method for children and adolescents who have been exposed to traumatic experiences and who are experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child and adolescent mental health clinics since 2012. The Ministry of Health is funding the implementation project, and the Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the implementation, including training of therapists, quality monitoring, and research.
Detailed description
All participating child and adolescent mental health clinics received training by TF-CBT senior trainers at NKVTS in screening for trauma exposure and posttraumatic stress. A sub-sample of the therapists received training in TF-CBT. Data are collected on treatment outcomes for quality assurance.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children screened for trauma and/or posttraumatic stress | – | Other: Trauma-focused cognitive behavioral therapy (TF-CBT)Children were screened for trauma exposure and posttraumatic stress at one of the first meetings at the child and adolescent mental health clinic. For participants receiving TF-CBT, posttraumatic stress was also assessed during and after therapy. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 6-18 referred to Norwegian child and adolescent mental health clinics.
Key inclusion criteria (2 listed)
- 6-18 years
- Referred to Norwegian child and adolescent mental health clinics
Key exclusion criteria (1 listed)
- Below 6 years and above 18 years
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 |
|---|---|---|
| Trauma-focused cognitive behavioral therapy (TF-CBT)TF-CBT is an evidence-based treatment method for children and adolescents who have been exposed to trauma and experience posttraumatic stress symptoms. The treatment model has a family and caregiver focus, and non-offending caregivers are included in the treatment. TF-CBT is normally provided through 8-12 treatment sessions. | Other | Children screened for trauma and/or posttraumatic stress |
Primary outcome
Child and Adolescent Trauma Screen (CATS)
Time frame: 2012-2014
Consists of two parts. Part 1 is a screening for exposure to potential traumatizing events; Part 2 is a screening for posstraumatic stress symptoms
Child PTSD Symptom Scale (CPSS)
Time frame: 2015-2021
Consists of two parts. Part 1 is a screening for exposure to potential traumatizing events; Part 2 is a screening for posstraumatic stress symptoms
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 21 Feb 2022.
- Derived from this study: PubMed 36175864Skar AS, Braathu N, Jensen TK, Ormhaug SM. Predictors of nonresponse and drop-out among children and adolescents receiving TF-CBT: investigation of client-, therapist-, and implementation factors. BMC Health Serv Res. 2022 Sep 29;22(1):1212. doi: 10.1186/s12913-022-08497-y.
- 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.
Ane-Marthe S Skar, PhD principal investigator
Norwegian Center for Violence and Traumatic Stress Studies
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Norwegian Center for Violence and Traumatic Stress Studies.
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 2 inclusion and 1 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Child and Adolescent Trauma Screen (CATS) (time frame: 2012-2014). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248971, which also lists 1 linked publication.
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 21 Feb 2022; AzTrials last refreshed its copy on 4 Nov 2026.