NCT07460817

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
May 2025Dec 2029

First Submitted

Initial submission to the registry

May 24, 2021

Completed
3.9 years until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

May 24, 2021

Last Update Submit

March 5, 2026

Conditions

Post Traumatic Stress Disorder

Keywords

TreatmentBrief interventionRandomized controlled trialStudy Protocol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The Satisfaction with Life Scale (SWLS)

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

  • Ruminative Responses Scale (RRS)

    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)

    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)

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

Study Arms (2)

BrainWorking Recursive Therapy

EXPERIMENTAL

Brief intervention for PTSD- single session (BWRT)

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

Behavioral: Treatment as usual

Interventions

BrainWorking Recursive TherapyBEHAVIORAL

one session therapy

BrainWorking Recursive Therapy
Treatment as usualBEHAVIORAL

evidence-based therapy

Treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Åsa Hammar, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2021

First Posted

March 10, 2026

Study Start

May 2, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)