The Key to Integrated Trauma Treatment in Psychosis (Kit) Trial: a Pragmatic, Multicenter Effectiveness RCT of EMDR for Trauma Symptoms in Schizophrenia Spectrum Disorders

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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)

• able and motivated for engaging in trauma focused (TF) therapy

• able to understand and give informed consent; consent capacity for psychological treatment choices and consent to study procedures.

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Helgeland Hospital HF
RECRUITING
Sandnessjøen
Contact Information
Primary
Else-Marie Løberg, PhD, Professor
else.marie.loberg@helse-bergen.no
4798094420
Backup
Nina Mørkved, PhD, Assoc. Professor
nina.morkved@helgelandssykehuset.no
4792286165
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 187
Treatments
Experimental: Trauma-focused therapy: EMDR for psychosis and treatment as usual (TAU)
Patients randomized to receive max. 26 sessions of EMDR for psychosis.
No_intervention: Treatment as usual (TAU) and waiting list (WL)
Patients randomized to continue with treatment as usual (TAU) for 6 months as a waiting list (WL) control group. TAU consists of an individual combination of treatments for SSDs in line with Norwegian national guideline (e.g. medication, cognitive therapy, work training, music therapy).
Related Therapeutic Areas
Sponsors
Collaborators: Helgeland Hospital Trust
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov