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Enrolling by invitation NCT07460817

A Brief Intervention for PTSD - BWRT

No phase Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BrainWorking Recursive Therapy, Treatment as usual.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral BrainWorking Recursive Therapy
    one session therapy
  • Behavioral Treatment as usual
    evidence-based therapy

Primary outcome measures

  • 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).]
Secondary outcome measures (4)
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • University of Bergen — Bergen

Identifiers

NCT: NCT07460817 · 191548

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗