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Enrolling by Invitation

NCT Number: NCT07460817

A Brief Intervention for PTSD - BWRT

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BrainWorking Recursive Therapy

Behavioral

one session therapy

Treatment as Usual

Behavioral

evidence-based therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

    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

  2. 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).

    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

  3. 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).

    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.

  4. 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).

    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.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

A Brief Intervention for PTSD Versus Treatment as Usual: Study Protocol for a Non-inferiority Randomized Controlled Trial

Acronym: BWRT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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