A Pilot Randomised Controlled Trial Investigating the Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) with and without Imagery Rehearsal Therapy (IRT) on Sleep Quality for Ex-Service Personnel with Insomnia and Nightmares in the Context of Posttraumatic Stress Disorder (PTSD) and Obstructive Sleep Apnoea (OSA)

Gallipoli Medical Research Foundation0 sites30 target enrollmentApril 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2019

End Date

March 23, 2021

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•Male or female ex\-serving Australian Defence Force personnel (i.e. veterans)
•Age greater than or equal to 18 years
•Diagnosis of PTSD: Have an accepted diagnosis of PTSD with the Australian Department of Veteran Affairs, or meet diagnostic criteria for lifetime PTSD according to the CAPS\-5
•Insomnia: A score of greater than or equal to 15 on the ISI (clinical insomnia, moderate severity)
•Nightmares: Distressing nightmares, with a frequency of at least 2 per month
•Poor sleep: A score of \>5 on the PSQI
•Stable pharmacological treatment for any condition for at least 1 month prior to baseline
•Willingness and ability to attend CBT\-I or CBT\-I\+IRT treatment sessions as required according to study protocol

•Current bipolar I disorder (presence of manic episode in the past 5 years): Meets DSM\-5 diagnostic criteria (as measured by the MINI 7\.0\), where further screening is indicated by the DSM\-5 Self\-Rated Level 1 Cross Cutting Symptom Measure\-Adult.
•Schizophrenia: Meets DSM\-5 current diagnostic criteria (as measured by the MINI 7\.0\), where further screening is indicated by the DSM\-5 Self\-Rated Level 1 Cross Cutting Symptom Measure\-Adult.
•Current psychosis: Meets DSM\-5 diagnostic Criterion A and B of schizophrenia diagnosis (as measured by the MINI 7\.0\), where further screening is indicated by the DSM\-5 Self\-Rated Level 1 Cross Cutting Symptom Measure\-Adult.
•Current imminent risk of suicide, as indicated by the Columbia Suicide Severity Rating Scale
•Unstable psychiatric condition, as indicated by hospitalisation for any psychiatric condition in the past four weeks
•Any neurological disorder known to impact sleep (e.g., narcolepsy, Parkinson’s disease)
•Previous diagnosis of moderate to severe traumatic brain injury (TBI) (i.e., loss of consciousness for more than 30 minutes) in the past five years
•Females who are pregnant or breastfeeding
•Inadequate circumstances for sleep e.g. night shift\-worker
•Currently receiving exposure\-based, trauma\-focused therapy (e.g. prolonged exposure therapy, trauma\-focused cognitive behavioural therapy and eye movement desensitisation reprocessing (EMDR) for PTSD