RecruitingNot ApplicableNCT06691347

Effectiveness of Trauma Treatment in the Specialist Health Care Services

Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial


Sponsor

Vestre Viken Hospital Trust

Enrollment

270 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how well PTSD (post-traumatic stress disorder) treatments work in specialist healthcare settings in Norway. It is a real-world effectiveness study observing how patients respond to standard trauma-focused therapies given in clinical practice. **You may be eligible if...** - You are 18 or older - You have been diagnosed with PTSD based on a clinical interview (CAPS-5 score of 23 or above) **You may NOT be eligible if...** - You do not have sufficient proficiency in Norwegian - You have severe intellectual impairment - You have another acute psychiatric condition that requires prioritised treatment (such as needing hospitalisation) - You have already received EMDR or CT-PTSD therapy previously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEye movement desensitization and reprocessing

Psychotherapy with EMDR. A therapist guides the client in recalling distressing events while simultaneously following a stimulus, like a moving light or tapping. The idea is that this bilateral stimulation helps reduce the intensity of the traumatic memory, allowing clients to gain perspective and lessen emotional distress associated with it. The standard treatment protocol includes up to 24 weekly sessions.

BEHAVIORALCognitive therapy for PTSD

Psychotherapy with CT-PTSD. A therapist works with the client to understand how they interpret their trauma and identify distorted thinking patterns that fuel their PTSD symptoms. Through guided discussions, written exercises, and sometimes "re-living" the trauma in a controlled way, clients learn to reshape these beliefs, gain a more balanced perspective, and reduce symptoms like hypervigilance, flashbacks, and avoidance behaviors. The standard treatment protocol includes up to 24 weekly sessions.


Locations(1)

Vestre Viken Health Trust

Drammen, Akershus, Norway

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NCT06691347


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