Data category | Information |
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Primary registry and trial identifying number | Australia and New Zealand Clinical Trials Network, registration number ACTRN12618000683235 (registered prospectively) |
Date of registration in primary registry | 26 April 2018 |
Sponsor | University of Otago Contact details: Office of Research and Enterprise, Otago University, Level 1, 87 St David Street, Dunedin, New Zealand. Tel. + 64 34 798 905 |
Contact for public/scientific queries | |
Public title | Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial |
Scientific title | Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial |
Countries of recruitment | New Zealand |
Health condition(s) or problem(s) studied | PTSD in people receiving care from forensic mental health services |
Intervention(s) | EMDR therapy |
Key inclusion and exclusion criteria | Inclusion criteria: aged 18–65 years; a lifetime history of a psychotic disorder or a mood disorder with psychotic features as diagnosed according to ICD-10 or DSM-5 criteria; meeting diagnostic criteria for PTSD (Clinician Administered PTSD Scale (CAPS)); current patient of the forensic and rehabilitation mental health services; competent to provide informed consent; likely to remain in the area for the 6-month trial duration (i.e., if a prisoner, release date at least 6 months away; if a patient within a forensic mental health service, their anticipated discharge is at least 6 months away) Exclusion criteria: high suicidality, operationalized as the combination of having a high suicidality score on the Mini International Neuropsychiatric Interview (MINI-plus) or with a suicide attempt within the past 6 months; mental state considered by the treating psychiatrist as too unstable to participate in the trial (participants may be experiencing chronic low-grade symptoms, but cannot be acutely psychotic); insufficient competence in the English language to understand, provide informed consent, and participate in therapy and data collection |
Study type | Single-blind, randomized controlled trial |
Date of first enrolment | 25 May 2018 |
Target sample size | 46 |
Recruitment status | Currently recruiting |
Primary outcome(s) | Change in PTSD symptoms (measured by the CAPS and PSS-SR), treatment safety (measured by the adverse event questionnaire), and acceptability of the EMDR treatment (measured by the TAAS and by qualitative participant feedback) |
Key secondary outcomes | Posttraumatic cognitions (PTCI), self-disturbance (TSI-2 Factor 1), posttraumatic stress (TSI-2 Factor 2), externalization (TSI-2 Factor 3), somatization (TSI-2 Factor 4), depression (BDI-II), psychosis (PSYRATS), overall functioning (WHODAS 2.0), social functioning (Social Functioning scale), self-esteem (RSES) |