Effectiveness of Trauma Treatment in the Specialist Health Care Services

Vestre Viken Hospital Trust

Status: Enrolling

Conditions: Cognitive Therapy; Quality of Life; Complex Post-Traumatic Stress Disorder; Functional Outcome; Post Traumatic Stress Disorder PTSD; Eye Movement Desensitization and Reprocessing

Treatments: Behavioral: Eye movement desensitization and reprocessing; Behavioral: Cognitive therapy for PTSD

Study type: Interventional

Funder types: Other

Identifiers

NCT06691347

REK 716204

Details and patient eligibility

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.

Full description

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Eye Movement Desensitization and Reprocessing

Experimental group

Description:

Patients will receive EMDR as their main treatment method of PTSD. EMDR processes trauma memories while engaging in bilateral stimulation to help rewire the brain's response to trauma and decrease emotional distress.

Treatment:

Behavioral: Eye movement desensitization and reprocessing

Cognitive Therapy for PTSD

Experimental group

Description:

Patients will receive CT-PTSD as their main treatment method of PTSD. CT-PTSD focuses on techniques such as cognitive restructuring and exposure therapy to help individuals reframe trauma and reduce intrusive memories and emotional distress.

Treatment:

Behavioral: Cognitive therapy for PTSD