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.
Participants will be recruited from Asker DPS, Bærum DPS, Drammen DPS, and Ringerike DPS. They were referred to DPS for PTSD treatment, either by general practitioners, other primary health care services in their municipality, or psychiatric hospitals. This study is a longitudinal multi-assessment 2-arm RCT and does not include a treatment as usual group. The standard treatment protocol includes up to 24 weekly sessions. Conversely, if no discernible improvement is seen after 10 sessions, it is recommended to terminate treatment. The clinical assessment consists of self-administered questionnaires collected through CheckWare, which is a digital platform developed for healthcare services. They will be asked to report symptoms of PTSD, depression, anxiety, psychosis, alcohol/drug use, functional outcomes, working alliance. Before treatment starts, patients will complete baseline assessments. Throughout the treatment phase, all patients will be requested to fill out self-administered questionnaires after each session.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
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.
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.
Vestre Viken Health Trust
Drammen, Akershus, Norway
RECRUITINGChanges in PTSD-symptoms
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.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in PTSD-symptoms
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.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in comorbid illnesses
Changes in symptoms related to depression as measured with The Beck Depression Inventory-II (BDI). The BDI-II consists of 21 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in comorbid illnesses
Changes in symptoms related to anxiety as measured with The Beck Anxiety Inventory (BAI). The BAI consists of 21 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in comorbid illnesses
Changes in symptoms related to psychosis as measured with MULVARP. MULVARP consists of Prodromal Questionnaire (PQ-16). It consists of 16 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-48, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in comorbid illnesses
Changes in symptoms related to alcohol use as measured with Alcohol Use Disorders Identification Test (AUDIT). The AUDIT consists of 10 items on a 5-point Likert scale ranging from 0-4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. Total scores range from 0-40, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in comorbid illnesses
Changes in symptoms related to drug use as measured with Drug Use Disorders Identification Test (DUDIT). The DUDIT consists of 11 items on a 5-point Likert scale ranging from 0-4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. Total scores range from 0-44, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in functional outcomes
Changes in Quality of Life questionnaire (QoL10) scores. The QoL10 consists of 10 items on a 5-point Likert scale ranging from 1-5. Total scores range from 0-50, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in functional outcomes
Changes in Work and Social Functioning (WSAS) scores. The WSAS consists of 5 items on a 9-point Likert scale ranging from 0-8. Total scores range from 0-40, where a higher score signifies a worse outcome.
Time frame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.