Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06691347

Effectiveness of Trauma Treatment in the Specialist Health Care Services

Led by Vestre Viken Hospital Trust · Updated on 2024-11-15

270

Participants Needed

1

Research Sites

322 weeks

Total Duration

On this page

Sponsors

V

Vestre Viken Hospital Trust

Lead Sponsor

N

Norwegian Center for Violence and Traumatic Stress Studies

Collaborating Sponsor

AI-Summary

What this Trial Is About

Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients. The main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.

CONDITIONS

Official Title

Effectiveness of Trauma Treatment in the Specialist Health Care Services

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score of 23 or higher
Not Eligible

You will not qualify if you...

  • Insufficient mastery of the Norwegian language
  • Severe intellectual impairment with an estimated IQ of 70 or less
  • Comorbid psychiatric illnesses in an acute phase requiring prioritized treatment such as hospitalization
  • History of prior EMDR or cognitive therapy for PTSD treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vestre Viken Health Trust

Drammen, Akershus, Norway, 3004

Actively Recruiting

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Research Team

S

Susie Fu, PhD, Cand. Psychol.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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