Effectiveness of Trauma Treatment in the Specialist Health Care Services

Condition(s) studied

Investigational drug(s) / intervention(s)

Eye 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.

Cognitive 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.

Study 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

Primary outcome measure(s)

• Changes in PTSD-symptoms — From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
  Changes in PTSD checklist for DSM-V (PCL-5) scores. The PCL-5 consists of 20 items on a 5-point Likert scale ranging from 0-4. Total scores range from 0-80, where a higher score signifies a worse outcome.
• Changes in PTSD-symptoms — From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
  The International trauma questionnaire (ITQ) scores. The ITQ consists of 18 items on a 5-point Likert scale ranging from 0-4. Total scores range from 0-72, where a higher score signifies a worse outcome.

Trial sites (1)

More Vestre Viken Hospital Trust trials in Norway

Other trials for the same condition