The Key to Integrated Trauma Treatment in Psychosis Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHaukeland University Hospital
About this trial
Schizophrenia spectrum disorders (SSDs) have a significant trauma etiology: trauma has been reported in 65 - 80% in this patient group and have a negative impact on prognosis. Trauma treatment is currently not offered in SSDs due to a lack of evidence. KIT is a pragmatic trial comparing the effectiveness of added trauma focused therapy, Eye Movement Desensitization and Reprocessing (EMDR) to standard treatment in SSDs.
The study will compare EMDR as add on to treatment as usual (TAU) to TAU in patients with schizophrenia spectrum disorders (SSDs). The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs.
Participants will receive max. 26 sessions of EMDR, and complete assessments before, during and after the course of therapy, in addition to a period of time (6 months) after therapy to examine long-term effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged ≥ 16 years
diagnosis of F20-29 in the ICD-10 assessed using SCID 5 CV
reporting trauma > 1 month prior to assessment
being currently distressed by the reported trauma(s), i.e., ≥ 5 (from 0 = not at all, to 10 = extremely) on item 21c on the Trauma and Life Events Checklist (TALE)
Disqualifiers
primary diagnosis of substance use/alcohol dependence
inability to understand spoken Norwegian
organic psychosis or a neurological disorder
hospitalized in an acute ward the last 6 weeks or
Trial design
Design model
Parallel
Treatments tested in this trial
Eye Movement Desensitization and Reprocessing (EMDR) for psychosis
Other interventionEMDR aims to treat and process trauma by safely retrieving the trauma memories while taxing the working memory. EMDR targets trauma symptoms through memory reprocessing of traumatic memories, and consists of eight flexible phases: history taking/case conceptualization; preparation for memory reprocessing; assessment/identification of a target memory; desensitization/reprocessing; installation of positive cognition; body scan; closure; and re-evaluation. EMDR in the current trial has psychosis-specific adaptations including focus on psychoeducation, preparation for reprocessing and patient safety. Techniques targeting dissociation, psychotic symptoms and psychosis-related challenges are included.
Treatment groups
187 Participants
are divided into 2 treatment groupsGroup A: Trauma-focused therapy: EMDR for psychosis and treatment as usual (TAU)Experimental treatment 1 intervention
Group B: Treatment as usual (TAU) and waiting list (WL)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Trauma symptoms
Primary outcome is trauma symptoms as measured by the International Trauma Questionnaire. PTSD symptom scale range from 0 to 24. Higher scores indicate more sever trauma symptoms.
Time frame
From baseline to end of treatment at 6 months.Secondary outcomes
1
Severity of psychosis symptoms
Secondary outcome is psychosis symptoms as measured by the The Positive and Negative Syndrome Scale (PANSS), which ranges from 30 to 210, with higher scores indicating more severity.
Time frame
From baseline to end of treatment at 6 months.2
The rate of autonomic arousal during trauma processing
Digital biomarkers measured with BioPoint wrist-worn device. Physiological stress reactivity is recorded non-invasively and continuously, offering an especially suitable means for monitoring objective physiological responses. Real-time assessments of hyperarousal, autonomic and somatic reactivity, and stress reactivity (including heart rate variability, skin conductance, respiration, and actigraphy) will be administered during EMDR sessions.
Time frame
Baseline to end of treatment at 6 months.3
Inflammation
Measure of inflammation markers (CRP, IL6) using blood samples
Time frame
Baseline and end of treatment at 6 monthsOther outcomes
1
Clinical stratification by trauma type and severity measured by the Childhood Trauma Questionnaire
Trauma type and severity as measured by the Childhood Trauma Questionnaire short form (CTQ-SF). CTQ-SF ranges from 25 to 125, with higher scores indicating more severe childhood trauma. Subscale scores range from 5-25 for the following sub scales: physical, emotional and sexual abuse, and physical and emotional neglect.
Time frame
Baseline to end of treatment at 6 months.2
Adverse events
No differences in adverse events is expected between the groups.
Time frame
Baseline to end of treatment at 6 months.3
Health care costs
No difference in health care costs is expected between the groups.
Time frame
Baseline to end of treatment at 6 months.4
Clinical stratification by trauma type and severity measured by the Traumatic experiences checklist
Severity and type of trauma measured by the Traumatic Experiences Checklist (TEC). The TEC indicates the presence of trauma on a scale from 0-29, higher scores indicating more exposure. TEC also include composite scores from 0-12 by developmental period, where higher scores indicate more severity.
Time frame
Baseline to end of treatment at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
Helgeland Hospital Trust
Collaborator
Diakonhjemmet Hospital
Collaborator
Helse Stavanger HF
Collaborator
Helse Fonna Hospital Trust
Collaborator
University Hospital of North Norway
Collaborator
Oslo University Hospital
Collaborator
Voss DPS Bjørkeli
Collaborator
Solli DPS
Collaborator
Betanien DPS
Collaborator
St. Olavs Hospital
Collaborator
Source ClinicalTrials.gov