A Pilot Randomised Controlled Trial of Cognitive Behavioural Therapy for Insomnia (CBT-I) and Imagery Rehearsal Therapy (IRT) for Ex-Service Personnel with Insomnia and Nightmares in the Context of Posttraumatic Stress Disorder (PTSD) and Obstructive Sleep Apnoea (OSA).

Not Applicable

• Conditions: Insomnia; Posttraumatic Stress Disorder (PTSD); Nightmares; Obstructive Sleep Apnoea; Mental Health - Anxiety; Mental Health - Other mental health disorders; Respiratory - Sleep apnoea

• Registration Number: ACTRN12619000642189
• Lead Sponsor: Gallipoli Medical Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Study Completion: 2021-03-23
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Currently receiving cognitive behavioural therapy for insomnia (CBT-I)
• Severe OSA requiring immediate treatment e.g. severe OSA (respiratory distress index (RDI) greater than or equal to 30 events/hour) with a score of greater than or equal to 15 on the ESS, and have been involved in a sleep or vigilance related car accident or near miss, or very severe OSA (RDI<50) with <70% saturation with cardiac arrhythmia

Study & Design

• Study Type: Interventional
• Study Design: Not specified