A Brief Intervention for PTSD - BWRT (BWRT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: BrainWorking Recursive Therapy; Behavioral: Treatment as usual

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • University of Bergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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),
• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BrainWorking Recursive Therapy; Brief intervention for PTSD- single session (BWRT)	Behavioral: BrainWorking Recursive Therapy; one session therapy
Experimental: Treatment as usual; 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	Behavioral: Treatment as usual; evidence-based therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).

Collaborators and Investigators

• Sponsor: University of Bergen
• Investigators: Principal Investigator: Åsa Hammar, PhD, University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Randomized controlled trial; Brief intervention; Study Protocol
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Therapeutics
• Other Study ID Numbers: 191548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No