Clinical trial NCT06691347: Effectiveness of Trauma Treatment in the Specialist Health Care Services
Official title: Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder PTSD
Quality of Life
Functional Outcome
Complex Post-Traumatic Stress Disorder
Eye Movement Desensitization and Reprocessing
Cognitive Therapy
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Norwegian Center for Violence and Traumatic Stress Studies
First posted: 2024-11-15
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Changes in PTSD-symptoms
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in PTSD-symptoms
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Secondary outcomes:
measure: Changes in comorbid illnesses
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in comorbid illnesses
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in comorbid illnesses
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in comorbid illnesses
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in comorbid illnesses
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in functional outcomes
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
measure: Changes in functional outcomes
timeFrame: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Other outcomes:
measure: The impact of therapeutic alliance on treatment effectiveness
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: In case of re-referral: number of days until re-referral
timeFrame: From end of treatment to 12 months afterwards
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Health Trust
state: Viken
Study officials:
affiliation: Vestre Viken Health trust
name: Susie Fu, Ph.D, Cand. Psychol.
role: PRINCIPAL_INVESTIGATOR
References: