The KIT trial is a pragmatic, assessor-blinded, parallel 2-group, superiority randomized
trial comparing the addition of EMDR to treatment as usual (TAU) versus waiting list (WL)
and TAU for EMDR on symptoms of trauma in patients with SSDs. Participants will be
randomized (1:1, block randomization by center and gender) to one of the two groups.
Aims, hypotheses, objectives:
The primary aim is to investigate the effectiveness of EMDR as an add-on treatment
for SSDs in standard clinical practice to target trauma symptoms.
The secondary aim is to improve personalized therapy through the exploration of
clinical stratification variables that may influence the effectiveness of EMDR.
The long-term aim is to guide clinical practice and, if shown to be effective, to
implement EMDR for patients with SSDs.
The primary objective: EMDR and treatment as usual (TAU) compared to waiting list
(WL) and TAU will reduce symptoms of trauma as measured by the ITQ (the
International Trauma Questionnaire) in SSDs.
The secondary objective: Stratification variables (trauma profile e.g. type,
severity, timing; gender; biomarkers of stress and immune system reactivity; digital
biomarkers of autonomous stress reactivity) influence the effectiveness of EMDR.
Expected results during the project period:
The EMDR group will show less trauma symptoms compared to the WL control group by
the end of treatment and possibly better functioning.
No differences for costs nor serious adverse events will emerge between the groups
at the end of treatment.
Better outcomes are expected for trauma characterized by mild to moderate severity
and later onset (e.g. related to experience of psychosis) as compared to CT (e.g.
abuse and neglect).
Although exploratory, patients with high levels of inflammation markers and/or
hyperarousal and autonomous reactivity to trauma benefit most from EMDR.
EMDR for psychosis therapists: Eighteen trial therapists are currently fully trained in
EMDR for psychosis in collaboration with Dr. Varese and colleagues at Manchester
University, and receive monthly supervision. At least 24 more will be trained by early
2025. Assuming some therapist drop-out, 40 trial therapists will be recruiting SSD
patients from their patient lists.
Assessments: Assessments will be performed for both groups by blinded research personnel
at baseline, mid-treatment (12 weeks), end of treatment (6 months), 6- and 12-months post
randomisation after end of treatment, in addition to digital patient feedback every 2
weeks from baseline to end of treatment at 6 months. The follow-up period after end of
treatment is to examine long-term effects.
Eligible participants will be given initial information (verbal, web page, pamphlets) by
the trial therapists, and then verbal and written information by research staff and asked
for informed consent to partake in the trial. Primary outcome will be measured by the
ITQ, a validated measure assessing reliable and clinically significant treatment-related
change in trauma symptoms, including symptoms of PTSD and complex PTSD, used in
outpatient clinics in Norway. Demographic and clinical information will be supplemented
by clinical records and national health registers (e.g. Legemiddel-registeret, Kontroll
og utbetaling av helserefusjoner, Kommunalt pasient og bruker-register, Norsk
pasientregister, Nasjonalt kvalitetsregister for behandling i psykisk for voksne).
Healthcare costs (e.g. use of all health care, health related financial support,
transportation) will be captured by the study nurses at each assessment point and through
health registers.
Patients' experience of trauma symptoms, working alliance and recovery will be assessed
through Norse Feedback digital self-report. The digital assessment of the main outcome
trauma symptoms (ITQ) will be captured every 2 weeks to closely monitor symptom
fluctuations, while recovery and therapist alliance follow the time points of the study
nurse assessments. This decentralised assessment is deemed particularly suitable in
mental health. Assessment of somatic status (heartrate, weight, blood pressure) will be
supplemented by blood samples of inflammation markers (CRP, IL6 and S-cortisol) and blood
samples to the Bergen Psychosis Biobank for later analysis (e.g. IL18). The digital
biomarkers heart rate variability, respiration rate (electro-
cardiography/photoplethysmography), activation/ movement (actigraphy) and skin
conductance (electrodermal activity) will be measured in-session by BioPoint wristworn
biosensor. Trial therapists will rate fidelity, patient safety related adverse events
(AE) and symptom exacerbation after each session, and variables facilitating
implementation before/after trial participation. For symptom-specific items on
suicidality, psychosis, substance abuse and hospitalisations. A sub-group of 30 patients
will be asked about their experience of the therapy with a qualitative interview after
treatment.
Work packages: Quality of assessments and analysis will be ensured by organising themes
in work packages (WP) headed by national experts; WP0 Study management, WP1 Clinical
outcome, WP2 Somatic status and biomarkers, WP3 Trauma characteristics, WP4 Treatment
alliance and user experience, WP5 Study imple-mentation, WP6 Health economic evaluation.
Protocol adherence: Hospital Clinical Monitor will ensure protocol implementation and
site responsibility. The protocol will be adhered to by all trial personnel, including
trial therapists and local PIs to ensure patient safety and trial quality. There will be
frequent meetings across sites and written agreements on site responsibility. All sites
will use electronic report files (CRF) via Viedoc for patient case report forms.
Organization: The KIT trial is organized in Bergen Psychosis Research Group (BPRG) at
Haukeland University Hospital. BPRG has extensive experience from clinical trials on SSDs
(ClinicalTrials.gov IDs NCT00932529, NCT01446328, NCT03340909, NCT02597439, NCT02146547).