Post Traumatic Stress DisorderBWRTNCT07460817
A Brief Intervention for PTSD - BWRT
A study testing BrainWorking Recursive Therapy and Treatment as usual in people with Post Traumatic Stress Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- BrainWorking Recursive Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNorway
- Study dates
- 2 May 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have experienced at least one traumatic experience throughout their lifetime
- Participants must meet the DSM-5 criteria for PTSD, or subthreshold PTSD
- The following DSM-5 criteria must be fulfilled:
- A (exposure to traumatic stressor),
- in addition to three out of four of the following symptom-clusters;
- B (intrusion),
Show all 10Show fewer
- C (avoidance),
- D (negative alterations in cognitions and mood),
- E (alterations in arousal and reactivity)
- A marked decline in functioning and symptom persistence for over a month
Who cannot join
- ongoing psychotic disorders, or a history of psychosis,
- severe suicidal ideation,
- bipolar disorder,
- BMI index too low to benefit from psychological interventions,
- severe alcohol or substance dependence,
- serious somatic illness or brain damage,
- participation in concurrent psychotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Brief Intervention for PTSD Versus Treatment as Usual: Study Protocol for a Non-inferiority Randomized Controlled Trial
The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.
Read the detailed description
Background: Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting lines, avoidant tendencies, shame and stigma, potentially leading to fewer people seeking therapy or premature dropouts. A potential solution to battling these barriers is Brain Working Recursive Therapy (BWRT), a single-session intervention for PTSD. Although not yet subjected to empirical investigation, clinical experiences suggest an often immediate and long-lasting effect following the intervention related to patient's symptomatology and functional abilities.
Methods: The current study protocol outlines a plan to conduct the first non-inferiority randomized controlled trial aimed to explore the efficacy of BWRT compared to treatment as usual (TAU). Eighty-two participants will be allocated at a 1:1 ratio to one of the following treatment conditions: (1) BWRT or (2) treatment as usual. Participants will be compared on several variables, including changes in PTSD symptoms (primary objective), and changes in perceived quality of life, rumination, functional and cognitive ability (secondary objective). Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Discussion: Should BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- BrainWorking Recursive Therapy, Treatment as usual
- Keywords
- Treatment, Brief intervention, Randomized controlled trial, Study Protocol
- 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.
BrainWorking Recursive TherapyBehavioural
one session therapy
Treatment as usualBehavioural
evidence-based therapy
| Study group | Role | What they receive |
|---|---|---|
| BrainWorking Recursive Therapy | Experimental | Brief intervention for PTSD- single session (BWRT) Receives: Behavioral: BrainWorking Recursive Therapy |
| Treatment as usual | Experimental | Treatment as usual with evidence-based therapy for PTSD provided within the Norwegian health care system and adhering to the National Institute for Health and Care Excellence (NICE) guidelines for treating PTSD Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Changes in PTSD symptoms A total severity score for PTSD symptoms will established based on the summed severity of each symptom, with scores ranging from 0-80. Higher score defines higher severity.
Measured: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Secondary outcomes (4)
The Satisfaction with Life Scale (SWLS)
Changes in perceived quality of life, A 5-item scale designed to measure global cognitive judgments of one's life satisfaction (high scores indicates high satisfaction). Range 5-35
Measured: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Ruminative Responses Scale (RRS)
Rumination. The scale consists of 22 statements related to ruminative tendencies, using a 4-point Likert scale to indicate frequency of different types of ruminative thinking, with responses ranging from 1 (almost never) to 4 (almost always). Range 0-88. High scores indicate high rumination
Measured: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Work and Social Adjustment Scale (WSAS)
The WSAS assesses participants' self-reported degree of impairment related to five domains of functioning (ability to work, home management, social leisure activities, private leisure activities, close relationships), consisting of one statement related to each domain, with a response scale indicating perceived impairment on a scale from 0 (not at all) to 8 (very severely) Range 0-40. 0-9= low impairment, 10-19 =moderate impairment, 20-40= severe impairment.
Measured: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Perceived Deficits Questionnaire-Depression, 5-item (PDQ-D5)
The PDQ-D5 is a 5-item questionnaire, assessing the presence of problems related to memory, attention and concentration during the past week. The PDQ-D5 uses a 5-point Likert scale, with answers ranging from 0 (never in the past 7 days) to 4 (very often [more than once a day]) High scores indicate high impairment in cognitive functioning. Range 0- 20.
Measured: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start2 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aasa Karin Hammar, University of Bergen
- Investigators
- Åsa Hammar, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460817
- Sponsor's protocol ID
- 191548
- Acronym
- BWRT
- Status last verified
- Feb 2026
- First submitted
- 24 May 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention for PTSD Versus Treatment as Usual: Study Protocol for a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07460817
- Acronym / sponsor ID
- BWRT / 191548
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Treatment, Brief intervention, Randomized controlled trial, Study Protocol
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Mar 2026 (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.
The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.
Detailed description
Background: Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting lines, avoidant tendencies, shame and stigma, potentially leading to fewer people seeking therapy or premature dropouts. A potential solution to battling these barriers is Brain Working Recursive Therapy (BWRT), a single-session intervention for PTSD. Although not yet subjected to empirical investigation, clinical experiences suggest an often immediate and long-lasting effect following the intervention related to patient's symptomatology and functional abilities.
Methods: The current study protocol outlines a plan to conduct the first non-inferiority randomized controlled trial aimed to explore the efficacy of BWRT compared to treatment as usual (TAU). Eighty-two participants will be allocated at a 1:1 ratio to one of the following treatment conditions: (1) BWRT or (2) treatment as usual. Participants will be compared on several variables, including changes in PTSD symptoms (primary objective), and changes in perceived quality of life, rumination, functional and cognitive ability (secondary objective). Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Discussion: Should BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrainWorking Recursive Therapy | Experimental | Behavioral: BrainWorking Recursive TherapyBrief intervention for PTSD- single session (BWRT) |
| Treatment as usual | Experimental | Behavioral: Treatment as usualTreatment as usual with evidence-based therapy for PTSD provided within the Norwegian health care system and adhering to the National Institute for Health and Care Excellence (NICE) guidelines for treating PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have experienced at least one traumatic experience throughout their lifetime
- Participants must meet the DSM-5 criteria for PTSD, or subthreshold PTSD
- The following DSM-5 criteria must be fulfilled:
- A (exposure to traumatic stressor),
- in addition to three out of four of the following symptom-clusters;
Key exclusion criteria (7 listed)
- ongoing psychotic disorders, or a history of psychosis,
- severe suicidal ideation,
- bipolar disorder,
- BMI index too low to benefit from psychological interventions,
- severe alcohol or substance dependence,
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 |
|---|---|---|
| BrainWorking Recursive Therapyone session therapy | Behavioural | BrainWorking Recursive Therapy |
| Treatment as usualevidence-based therapy | Behavioural | Treatment as usual |
Primary outcome
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Changes in PTSD symptoms A total severity score for PTSD symptoms will established based on the summed severity of each symptom, with scores ranging from 0-80. Higher score defines higher severity.
4 secondary outcomes
The Satisfaction with Life Scale (SWLS)
Time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Ruminative Responses Scale (RRS)
Time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Work and Social Adjustment Scale (WSAS)
Time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Perceived Deficits Questionnaire-Depression, 5-item (PDQ-D5)
Time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Not yet recruiting
Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)
Insomnia, Depression - Major Depressive 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.
Åsa Hammar, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainWorking Recursive Therapy and Treatment as usual in people with Post Traumatic Stress Disorder, run by University of Bergen 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 10 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: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).). 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 10 Mar 2026.