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Trial registered on ANZCTR


Registration number
ACTRN12619000642189
Ethics application status
Approved
Date submitted
24/04/2019
Date registered
30/04/2019
Date last updated
31/03/2021
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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).
Scientific title
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)
Secondary ID [1] 297943 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 312333 0
Posttraumatic Stress Disorder (PTSD) 312334 0
Nightmares 312335 0
Obstructive Sleep Apnoea 312342 0
Condition category
Condition code
Mental Health 310895 310895 0 0
Anxiety
Mental Health 310896 310896 0 0
Other mental health disorders
Respiratory 310906 310906 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314164 0
Treatment: Other
Intervention code [2] 314318 0
Behaviour
Comparator / control treatment
The comparator treatment will include Cognitive Behavioural therapy for Insomnia (CBT-I) only.
CBT-I 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 in locations with suitable group treatment facilities such as an ex-service community organisation. Participants will attend 8 x 60 minute CBT-I 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

Participants will be provided with participant treatment manuals and supplemental handouts to complement the material discussed in sessions. CBT-I manuals and handouts were 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.
Control group
Active

Outcomes
Primary outcome [1] 319718 0
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 319718 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20) (Primary endpoint)
Secondary outcome [1] 369281 0
Change in insomnia severity as measured by the Insomnia Severity Index (ISI)
Timepoint [1] 369281 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [2] 369282 0
Change in nightmare frequency as measured by the Nightmare Frequency Questionnaire
Timepoint [2] 369282 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [3] 369283 0
Change in nightmare related distress as measured by the Nightmare Distress Questionnaire (NDQ)
Timepoint [3] 369283 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [4] 369284 0
Change in daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)
Timepoint [4] 369284 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [5] 369285 0
Change in functional impairement related to poor sleep as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
Timepoint [5] 369285 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [6] 369286 0
Change in objective sleep parameters as measured by actigraphy with sleep diary and polysomnography
Timepoint [6] 369286 0
Pre-treatment, post-treatment (Week 8)
Secondary outcome [7] 369287 0
Change in PTSD severity as measured by the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [7] 369287 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [8] 369288 0
Change in psychological distress as measured by the Depression Anxiety and Stress Scales-21 (DASS-21)
Timepoint [8] 369288 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)
Secondary outcome [9] 369289 0
Change in physical and mental health status as measured by the 36-Item Short Form Health Survey (SF-36)
Timepoint [9] 369289 0
Baseline (Week 0), post-treatment (Week 8), 3 months post-treatment (Week 20)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment arms will be assigned via pre-prepared sealed opaque envelopes, and the envelopes will be ordered in the sequence of arm assignments generated by the R code. Once a participant’s eligibility has been determined, the first available envelope will be assigned to the participant, and the participant will be randomised to the treatment arm indicated inside the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 into treatment groups of CBT-I and CBT-I+IRT stratified by OSA risk (low risk/high risk) and use of prescription sleep medication (no/yes) using random block sizes of 2, 4, and 6. The randomisation sequence will be created using R statistical software (R Foundation for Statistical Computing).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome for the study will be subjective sleep quality measured by the Pittsburgh Sleep Quality Index from baseline to three-month follow-up, performed on a modified ITT basis with the exclusion of participants who dropped out prior to any treatment. The analysis will be performed using an analysis of covariance (ANCOVA), with covariates of baseline PSQI and OSA risk. A secondary analysis will also be performed on a per-protocol basis using complete PSQI data at baseline and three-month follow-up.

An exploratory analysis of the secondary outcomes of sleep quality scores (ISI, NFQ, NDQ, ESS, FOSQ, IRLSSG, actigraphy and sleep and nightmare diary) and psychological measures (PCL-5, DASS-21, SF-36) between treatment groups at post-treatment and three month follow-up will be performed using ANCOVA with the same covariates as for the primary outcome, in addition to an exploratory ITT analysis using longitudinal mixed effects models on all available data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
On 1 October 2020, a decision was made by the study team, in consultation with the Department of Veterans Affairs’, to prematurely close study recruitment. Recruitment to the study ceased as of the 19 October 2020.

This study received over 200 expressions of interest (EOI), with strongest interest received at the start of the project. In 2020, however, we experienced a significant decline in new EOIs from potential participants. This reduction is largely attributed to the impact of COVID-19 on the acceptability and feasibility of undertaking group therapy sessions at our hospital facility. Another significant contributing factor to the recruitment challenges has been the strict inclusion and exclusion criteria required of this study. This factor resulted in a low percentage of EOIs received translating into enrolled eligible participants.

On review of the EOIs received in the three months prior to study closure (July-September 2020; less than five per month), it was determined that there was no possibility of achieving the target participant number of 60 in the proposed timelines for the Veteran Sleep Therapy Study.

The final intervention groups were run from 21 October to 10 December 2020. No further groups will be offered in 2021.
Date of first participant enrolment
Anticipated
15/05/2019
Actual
20/05/2019
Date of last participant enrolment
Anticipated
31/10/2020
Actual
13/10/2020
Date of last data collection
Anticipated
31/03/2021
Actual
23/03/2021
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13624 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 26291 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 302457 0
Government body
Name [1] 302457 0
Department of Veterans' Affairs
Country [1] 302457 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Gallipoli Medical Research Foundation
Address
Greenslopes Private Hospital
Newdegate Street, Greenslopes
4120 Queensland
Country
Australia
Secondary sponsor category [1] 302361 0
None
Name [1] 302361 0
Address [1] 302361 0
Country [1] 302361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303126 0
Departments of Defence and Veterans' Affairs Human and Research Ethics Committee
Ethics committee address [1] 303126 0
Ethics committee country [1] 303126 0
Australia
Date submitted for ethics approval [1] 303126 0
14/01/2019
Approval date [1] 303126 0
01/04/2019
Ethics approval number [1] 303126 0
100-19
Ethics committee name [2] 303131 0
Ramsay Health Care QLD Human Research Ethics Committee
Ethics committee address [2] 303131 0
Ethics committee country [2] 303131 0
Australia
Date submitted for ethics approval [2] 303131 0
27/11/2018
Approval date [2] 303131 0
14/02/2019
Ethics approval number [2] 303131 0
18/56

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92562 0
Ms Miriam Dwyer
Address 92562 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
4120 Queensland
Country 92562 0
Australia
Phone 92562 0
+61 7 3394 7284
Fax 92562 0
Email 92562 0
dwyermiriam@ramsayhealth.com.au
Contact person for public queries
Name 92563 0
Miriam Dwyer
Address 92563 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
4120 Queensland
Country 92563 0
Australia
Phone 92563 0
+61 7 3394 7284
Fax 92563 0
Email 92563 0
dwyermiriam@ramsayhealth.com.au
Contact person for scientific queries
Name 92564 0
Miriam Dwyer
Address 92564 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
4120 Queensland
Country 92564 0
Australia
Phone 92564 0
+61 07 3394 7284
Fax 92564 0
Email 92564 0
dwyermiriam@ramsayhealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to confidentiality and ethical reasons we will not be making individual participant data available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.