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Table 2 Items from the World Health Organization Trial Registration Data Set

From: 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

Data category

Information

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

susanna.every-palmer@otago.ac.nz

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)

  1. BDI-II, Beck Depression Inventory—second edition; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, fifth edition; EMDR, eye movement desensitization and reprocessing; ICD-10, International Classification of Diseases, 10th edition; PSS-SR, Posttraumatic Stress Disorder Symptom Scale—Self-Report; PTCI, Posttraumatic Cognitions Inventory; PSYRATS, Psychotic Symptom Rating Scales; PTSD, posttraumatic stress disorder; RSES, Rosenberg Self-Esteem Scale, TAAS, Treatment Acceptability/Adherence Scale; TSI-2, Trauma Symptom Inventory—second edition; WHODAS, World Health Organization Disability Assessment Scale