None listed
Conditions
Brief summary
The primary aim of this study is to determine whether the addition of IRT to CBT-I improves sleep disturbances in ex-service personnel with PTSD, insomnia, and nightmares compared to CBT-I alone. This study also aims to explore if risk of obstructive sleep apnoea (OSA) negatively moderates treatment outcomes in ex-service personnel receiving either CBT-I or CBT-I+IRT. Participants will be a minimum of 60 ex-serving personnel with PTSD, insomnia, and nightmares. Eligible participants will be randomised to either CBT-I or CBT-I+IRT treatment groups. Participants will attend 8 x weekly 60 minute CBT-I group sessions or 8 x weekly 120 minute CBT-I+IRT group sessions. Participants will complete a series of outcome measures at three time points (baseline, post-intervention, and at three months post-intervention). It is expected that the addition of IRT to CBT-I treatment will result in greater reduction in sleep disturbances than treatment with CBT-I alone.
Interventions
Brief name: Cognitive Behavioural Therapy for Insomnia with Imagery Rehearsal Therapy (CBT-I+IRT)
CBT-I+IRT will be facilitated by two clinical masters or doctoral-level trained psychologists.
Group treatment sessions will take place at Gallipoli Medical Research Foundation in Greenslopes Private Hospital, Mates4Mates Brisbane Family Recovery Centre, or locations with suitable group treatment facilities such as an ex-service community organisation. Participants will attend 8 x 120 minute CBT-I+
Brief name: Cognitive Behavioural Therapy for Insomnia with Imagery Rehearsal Therapy (CBT-I+IRT) CBT-I+IRT will be facilitated by two clinical masters or doctoral-level trained psychologists. Group treatment sessions will take place at Gallipoli Medical Research Foundation in Greenslopes Private Hospital, Mates4Mates Brisbane Family Recovery Centre, or locations with suitable group treatment facilities such as an ex-service community organisation. Participants will attend 8 x 120 minute CBT-I+IRT weekly sessions. Group size will be from approximately 3-8 (maximum 10) participants. CBT-I will cover topics such as: Psychoeducation about sleep Sleep restriction Stimulus control Relaxation training Sleep hygiene Cognitive challenging IRT will cover topics such as: Psychoeducation about PTSD, sleep, and nightmares Grounding strategies Imagery and experiential practice exercises Challenging one’s nightmare identity Dream Identification and Rescripting Rescript Imagery Rehearsal Participants will be provided with participant treatment manuals and supplemental handouts to complement the material discussed in sessions. Participants will be provided with a copy of the IRT Manual: Turing Nightmares into Dreams by Barry Krakow and CBT-I manuals have been designed specifically for this study. Each of the eight sessions will include a review of information provided the week before, an educational component during which new materials is introduced, and a group discussion aimed at addressing problems the participants experience in treatment implementation. Participants will complete daily paper sleep diaries to record homework practice, and subjective sleep parameters including a sleep quality rating, a record of daytime naps, medication/alcohol use for sleep, bed time, number of minutes to fall asleep, awakenings (quantity and duration), nightmares, rising time and time individual got out of bed in the morning. As part of the CBT-I protocol all sessions will include a review of each participants sleep diary during which a sleep window for the week is determined based on sleep diary data. The sleep window is a part of the sleep restriction technique included in the CBT-I protocol. Treatment fidelity will be assessed by independent post-graduate trained clinical psychologists (external to the study) using a scale developed for this study based on treatment manual content which will be used consistently across all selected audio tapes. A random sample of 10% of audio recorded treatment sessions will be rated to determine facilitators' adherence to the treatment manual. All facilitators will be trained in both intervention protocols and will receive supervision throughout the course of treatment interventions.
Sponsors
Gallipoli Medical Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed