PTSDNCT05598099
Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study
An observational study of PTSD, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Concentrated cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2022to 10 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with PTSD recruited from clinics and popular media referred to Clinic for 4-Day Treatment at Haukeland University Hospital, Bergen, Norway
Who may be able to join
- fulfills DSM-5 criteria for PTSD
- One or more single traumas in adolescence or adulthood
- Speaks and writes Norwegian
Who cannot join
- New or unstable psychopharmacological treatment within last four weeks
- fulfills ICD-11 criteria for complex PTSD
- Ongoing substance abuse
- Ongoing danger of suicide
- Ongoing borderline personality disorder
- Ongoing psychosis
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Anders L Thorsen, PhD, 90367617 ext. +47, anders.lillevik.thorsen@helse-bergen.no
About this study
Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.
Read the detailed description
The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.
- Conditions
- PTSD
- Being tested
- Concentrated cognitive behavioral therapy
- Keywords
- CBT, CAPS, Group therapy, Psychotherapy, Treatment satisfaction
- 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.
Concentrated cognitive behavioral therapyBehavioural
Also called Bergen 4-Day Treatment
A psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life
| Study group | Role | What they receive |
|---|---|---|
| Individual therapy over four consecutive days | Treatment will be delivered individually over four consecutive days Receives: Behavioral: Concentrated cognitive behavioral therapy | |
| Combined Individual and group therapy over four consecutive days | Treatment will be delivered in a mix of individual and group sessions over four consecutive days Receives: Behavioral: Concentrated cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-administered interview to diagnose and the severity of PTSD
Measured: Change in scores from before treatment to one week after treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-administered interview to diagnose and the severity of PTSD
Measured: Change in scores from one week after treatment to three months after treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-administered interview to diagnose and the severity of PTSD
Measured: Change in scores from three months after treatment to twelve months after treatment
Secondary outcomes (3)
Client Satisfaction Questionnaire 8 (CSQ-8)
Patient-rated questionnaire of treatment satisfaction
Measured: One week after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)
Patient-rated questionnaire of treatment satisfaction
Measured: Three months after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)
Patient-rated questionnaire of treatment satisfaction
Measured: Twelve months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
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.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Anders L Thorsen, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598099
- Sponsor's protocol ID
- B4DT-PTSD1
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is not planned
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study
- ClinicalTrials.gov ID
- NCT05598099
- Acronym / sponsor ID
- B4DT-PTSD1
- Conditions
- PTSD
- Keywords
- CBT, CAPS, Group therapy, Psychotherapy, Treatment satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 28 Oct 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.
Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.
Detailed description
The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual therapy over four consecutive days | – | Behavioral: Concentrated cognitive behavioral therapyTreatment will be delivered individually over four consecutive days |
| Combined Individual and group therapy over four consecutive days | – | Behavioral: Concentrated cognitive behavioral therapyTreatment will be delivered in a mix of individual and group sessions over four consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with PTSD recruited from clinics and popular media referred to Clinic for 4-Day Treatment at Haukeland University Hospital, Bergen, Norway
Key inclusion criteria (3 listed)
- fulfills DSM-5 criteria for PTSD
- One or more single traumas in adolescence or adulthood
- Speaks and writes Norwegian
Key exclusion criteria (7 listed)
- New or unstable psychopharmacological treatment within last four weeks
- fulfills ICD-11 criteria for complex PTSD
- Ongoing substance abuse
- Ongoing danger of suicide
- Ongoing borderline personality disorder
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 |
|---|---|---|
| Concentrated cognitive behavioral therapyAlso: Bergen 4-Day TreatmentA psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life | Behavioural | Combined Individual and group therapy over four consecutive days, Individual therapy over four consecutive days |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Change in scores from before treatment to one week after treatment
Clinician-administered interview to diagnose and the severity of PTSD
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Change in scores from one week after treatment to three months after treatment
Clinician-administered interview to diagnose and the severity of PTSD
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Change in scores from three months after treatment to twelve months after treatment
Clinician-administered interview to diagnose and the severity of PTSD
3 secondary outcomes
Client Satisfaction Questionnaire 8 (CSQ-8)
Time frame: One week after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)
Time frame: Three months after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)
Time frame: Twelve months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No. Sharing of IPD is not planned
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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.
Anders L Thorsen, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Haukeland University Hospital 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders L Thorsen, PhD (90367617 ext. +47, anders.lillevik.thorsen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Change in scores from before treatment to one week after treatment). The study lists 3 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 28 Oct 2022.