Post Traumatic Stress DisorderNCT05042323
Short-term Intervention and Health Trajectories After Mass Trauma
A study testing TF-CBT-Short in people with Post Traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
Trial summary
This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- TF-CBT-Short
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 15 Mar 2021to 15 Mar 2023
- 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 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Exposed to the landslide
- Between 6-19 years old
- A score of 15 or more on the CATS
- A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.
Who cannot join
- Suicidal
- Psychotic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma
This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. The second is to understand what may be effective early interventions to prevent long-term health and psychosocial problems for youth (6-19). Participants are recruited from an outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted and screened for trauma related difficulties. Those who have significant post-trauma reactions are offered trauma focused interventions.
Read the detailed description
Two short step-wise interventions are developed for this study as an early intervention after mass trauma based on components from TF-CBT to test the relative importance of dosage and the sequencing of components.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- TF-CBT-Short
- 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.
TF-CBT-ShortBehavioural
Participants receive either 4-5 sessions of TF-CBT-Skills or TF-CBT-Narr. If the participant still has significant PTSS they are provided with step two which is the components provided in the arm they did not receive.
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT-Skills | Experimental | Step 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing Receives: Behavioral: TF-CBT-Short |
| TF-CBT-Narr | Active comparator | Step 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building Receives: Behavioral: TF-CBT-Short |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.
Measured: Pre-treatment
PTSD
Measured with the CATS (after 4-5 sessions)
Measured: After 5 weeks
PTSD
Measured with the CATS (for those who continue to Step two)
Measured: After 9 weeks
PTSD
Measured with the CATS
Measured: After 21 weeks
PTSD
Measured with the CATS
Measured: After 33 weeks
PTSD
Measured with the CATS
Measured: After 45 weeks
PTSD
Measured with the CATS
Measured: After 57 weeks
Secondary outcomes (7)
Depression
Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.
Measured: Pre-treatment
Depression
Measured with MFQ-short
Measured: After 5 weeks
Depression
Measured with MFQ-short
Measured: After 9 weeks
Depression
Measured with MFQ-short
Measured: After 21 weeks
Depression
Measured with MFQ-short
Measured: After 33 weeks
Depression
Measured with MFQ-short
Measured: After 45 weeks
Depression
Measured with MFQ-short
Measured: After 57 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start15 Mar 2021
- Primary completion1 Aug 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tine K Jensen, PhD, Principal investigator, Norwegian Center for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042323
- Sponsor's protocol ID
- Gjerdrum
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2021
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma
- ClinicalTrials.gov ID
- NCT05042323
- Acronym / sponsor ID
- Gjerdrum
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 13 Sep 2021 (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.
This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. The second is to understand what may be effective early interventions to prevent long-term health and psychosocial problems for youth (6-19). Participants are recruited from an outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted and screened for trauma related difficulties. Those who have significant post-trauma reactions are offered trauma focused interventions.
Detailed description
Two short step-wise interventions are developed for this study as an early intervention after mass trauma based on components from TF-CBT to test the relative importance of dosage and the sequencing of components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TF-CBT-Skills | Experimental | Behavioral: TF-CBT-ShortStep 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing |
| TF-CBT-Narr | Active comparator | Behavioral: TF-CBT-ShortStep 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Exposed to the landslide
- Between 6-19 years old
- A score of 15 or more on the CATS
- A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.
Key exclusion criteria (2 listed)
- Suicidal
- Psychotic
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 |
|---|---|---|
| TF-CBT-ShortParticipants receive either 4-5 sessions of TF-CBT-Skills or TF-CBT-Narr. If the participant still has significant PTSS they are provided with step two which is the components provided in the arm they did not receive. | Behavioural | TF-CBT-Narr, TF-CBT-Skills |
Primary outcome
PTSD
Time frame: Pre-treatment
Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.
PTSD
Time frame: After 5 weeks
Measured with the CATS (after 4-5 sessions)
PTSD
Time frame: After 9 weeks
Measured with the CATS (for those who continue to Step two)
PTSD
Time frame: After 21 weeks
Measured with the CATS
PTSD
Time frame: After 33 weeks
Measured with the CATS
PTSD
Time frame: After 45 weeks
Measured with the CATS
PTSD
Time frame: After 57 weeks
Measured with the CATS
7 secondary outcomes
Depression
Time frame: Pre-treatment
Depression
Time frame: After 5 weeks
Depression
Time frame: After 9 weeks
Depression
Time frame: After 21 weeks
Depression
Time frame: After 33 weeks
Depression
Time frame: After 45 weeks
Depression
Time frame: After 57 weeks
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 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Tine K Jensen, PhD principal investigator
Norwegian Center for Violence and Traumatic Stress Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TF-CBT-Short in people with Post Traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
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 4 inclusion and 2 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 16 May 2023. 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 Norway. 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?
PTSD (time frame: Pre-treatment). The study lists 7 primary outcomes in all. 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 16 May 2023.