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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BrainWorking Recursive Therapy | Experimental | Brief intervention for PTSD- single session (BWRT) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainWorking Recursive Therapy | Behavioral | one session therapy |
| |
| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Åsa Hammar, PhD | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bergen | Bergen | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2024 | Mar 5, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2024 | Feb 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual |
| Behavioral |
evidence-based therapy |
|
| 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). |