NCT06691347 Effectiveness of Trauma Treatment in the Specialist Health Care Services
| NCT ID | NCT06691347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vestre Viken Hospital Trust |
| Condition | Post Traumatic Stress Disorder PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2024-09-26 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * age ≥18 years * meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23 Exclusion Criteria: * insufficient mastery of the Norwegian language * severe intellectual impairment (estimated IQ of 70 or less) * comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization) * history of EMDR or CT-PTSD treatment
Contact & Investigator
Susie Fu, Ph.D, Cand. Psychol.
PRINCIPAL INVESTIGATOR
Vestre Viken Health trust
Frequently Asked Questions
Who can join the NCT06691347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691347 currently recruiting?
Yes, NCT06691347 is actively recruiting participants. Contact the research team at susifu@vestreviken.no for enrollment information.
Where is the NCT06691347 trial being conducted?
This trial is being conducted at Drammen, Norway.
Who is sponsoring the NCT06691347 clinical trial?
NCT06691347 is sponsored by Vestre Viken Hospital Trust. The principal investigator is Susie Fu, Ph.D, Cand. Psychol. at Vestre Viken Health trust. The trial plans to enroll 270 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.