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Trial registered on ANZCTR


Registration number
ACTRN12616000586415
Ethics application status
Approved
Date submitted
27/04/2016
Date registered
5/05/2016
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Researching Effective Sleep Treatments (REST): The effectiveness of partner-assisted treatments for insomnia using Cognitive Behavioural Therapy (CBT) and sleep hygiene therapy (SHT).
Scientific title
Researching Effective Sleep Treatments (REST): The effectiveness of partner-assisted treatments for insomnia using Cognitive Behavioural Therapy (CBT) and sleep hygiene therapy (SHT).
Secondary ID [1] 288319 0
Nil
Universal Trial Number (UTN)
Trial acronym
REST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 297491 0
Condition category
Condition code
Mental Health 297679 297679 0 0
Other mental health disorders
Neurological 298685 298685 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three interventions: partner-assisted Cognitive Behaviour Therapy for Insomnia (PA-CBTI), individual Cognitive Behaviour Therapy for Insomnia (I-CBTI) or partner-assisted sleep hygiene therapy (PA-SHT). Regardless of which intervention they are assigned, participants will attend 7 weekly 1-hour treatment sessions, wear an actigraph and complete daily sleep diaries.
CBTi is a multicomponent intervention. Clinicians work with clients to help them make changes to their sleep-wake patterns, to improve sleep. This includes setting regular sleep and wake times, getting out of bed when one is unable to sleep, sleep restriction and stimulus control. CBTi also addresses common misconceptions about sleep and unhelpful thought patterns, which may be perpetuating sleep problems. Finally, CBTi includes education about improving the sleep environment and relaxation techniques.
SHT focuses on education about sleep-wake cycles and helps participants to change and improve basic lifestyle habits that impact on sleep (e.g., avoiding caffeine late in the day).
In the partner-assisted conditions, the partner participates in every therapy session, and learns all the same information as the patient. The partner plays a supportive role, helping the patient to make behavioural changes in between treatment sessions. This includes reinforcing positive changes and helping to create an environment that encourages positive change. All treatment sessions, regardless of condition, take the format of individual one-on-one sessions (i.e., one sleep clinician per couple or client). Sleep clinicians are registered psychologists, with expertise in sleep. Irrespective of condition, participants are asked to complete a daily sleep diary throughout the treatment program and to practice 1-3 strategies learnt in session in between therapy sessions. Ideally, these strategies are used daily. Participants will complete a daily sleep diary and a weekly adherence questionnaire with the help of the sleep clinician to monitor adherence.
Participants will wear the actigraph 24-hours per day (except when engaged in activities that may damage the device) throughout the 7 week intervention period.
Intervention code [1] 293796 0
Behaviour
Intervention code [2] 294638 0
Treatment: Other
Comparator / control treatment
partner-assisted Cognitive Behaviour Therapy for Insomnia (PA-CBTI)
individual Cognitive Behaviour Therapy for Insomnia (I-CBTI)
partner-assisted sleep hygiene therapy (PA-SHT)

All 3 are expected to help insomnia symptoms.
Control group
Active

Outcomes
Primary outcome [1] 297247 0
A primary outcome is adherence to Stimulus Control as assessed by the sleep diary.
Timepoint [1] 297247 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Primary outcome [2] 306419 0
A primary outcome is adherence to Sleep Restriction as assessed by the sleep diary.
Timepoint [2] 306419 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Primary outcome [3] 306420 0
A primary outcome is completion rates as assessed by those randomised to a treatment condition and who completed at least the first treatment session
Timepoint [3] 306420 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [1] 320378 0
The secondary outcome is relationship functioning. This is operationalised by scores on the Dyadic Adjustment Scale, Communication Patterns Questionnaire and Partner Criticism Scale.
Timepoint [1] 320378 0
The primary timepoints are before treatment (baseline), immediately following the last treatment session, and six months after the last treatment session,
Secondary outcome [2] 320461 0
Another secondary outcome is psychiatric symptoms - post-traumatic stress disorder. This is operationalised by scores on the the Posttraumatic Stress Disorder Checklist-5.
Timepoint [2] 320461 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [3] 323365 0
Psychiatric symptoms - depression. This is operationalised by scores on the Patient Health Questionnaire-9.
Timepoint [3] 323365 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [4] 323366 0
Psychiatric symptoms - anxiety. This is operationalised by scores on the Beck Anxiety Inventory.
Timepoint [4] 323366 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [5] 323367 0
Quality of Life. This is operationalized by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.
Timepoint [5] 323367 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [6] 323368 0
Another secondary outcome is bed partners' sleep-wake patterns and problems. This is operationalised by activity recorded via sleep diaries.
Timepoint [6] 323368 0
The timepoints are 1. at the start of treatment (pre-treatment/baseline; 1 week) 2. prior to the last treatment session (post-treatment; 1 week) and 3. six months after the last treatment session (follow-up; 1 week).
Secondary outcome [7] 323369 0
The bed partners' sleep-wake patterns and problems as assessed with actigraphy.
Timepoint [7] 323369 0
The timepoints are 1. at the start of treatment (pre-treatment/baseline; 1 week) 2. prior to the last treatment session (post-treatment; 1 week) and 3. six months after the last treatment session (follow-up; 1 week).
Secondary outcome [8] 323370 0
The bed partner's insomnia symptoms as assessed with the Insomnia Severity Index.
Timepoint [8] 323370 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).
Secondary outcome [9] 348503 0
Client sleep-diary sleep efficiency
Timepoint [9] 348503 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. immediately following the last treatment session (post-treatment) and 3. six months after the last treatment session (follow-up).

Eligibility
Key inclusion criteria
Key inclusion criteria for individuals with Insomnia Disorder include:
a) diagnosis of Insomnia Disorder, per DSM-5; b) 18 years old or over; c) English literacy; and d) having a bed partner willing to participate in the study.

Bed partners may or may not have problems sleeping.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria for individuals with Insomnia Disorder:
a) unmanaged serious mental illness; b) untreated sleep disorders other than insomnia (sleep disorders stably treated, such as obstructive sleep apnoea treated with CPAP, will be allowed); c) shift work; d) substance abuse in the past 90 days

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292806 0
Government body
Name [1] 292806 0
National Health and Medical Research Council
Address [1] 292806 0
Level 1

16 Marcus Clarke Street

Canberra ACT 2601
Country [1] 292806 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 291602 0
None
Name [1] 291602 0
Address [1] 291602 0
Country [1] 291602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294306 0
Monash University Human Research Ethics Committees (MUHREC)
Ethics committee address [1] 294306 0
First Floor, Room 111
Chancellery Building E
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 294306 0
Australia
Date submitted for ethics approval [1] 294306 0
29/01/2016
Approval date [1] 294306 0
18/02/2016
Ethics approval number [1] 294306 0
CF16/276 - 2016000125

Summary
Brief summary
The aim of this study is to compare three different treatments for decreasing the symptoms of insomnia. There are certain factors that may impact the effectiveness of treatments for insomnia. Therefore comparing these three treatments will help us develop a more effective way to treat insomnia. This study is the first well controlled comparison of these treatments. This study also investigates whether having a bed partner affects a person's sleep in any way.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62742 0
Prof Sean PA Drummond
Address 62742 0
Monash University School of Psychological Sciences,
18 Innovation Walk, Clayton Campus,
Wellington Road, Monash University,
VIC, 3800 Australia
Country 62742 0
Australia
Phone 62742 0
+61 3 9905 3956
Fax 62742 0
Email 62742 0
sean.drummond@monash.edu
Contact person for public queries
Name 62743 0
Dr Alix Mellor
Address 62743 0
Sleep and Circadian Medicine Laboratory
Be Active Sleep Eat Facility
264 Ferntree Gully Road,
Monash University, Notting Hill VIC 3168, Australia
Country 62743 0
Australia
Phone 62743 0
+61 3 99055912
Fax 62743 0
Email 62743 0
alix.mellor@monash.edu
Contact person for scientific queries
Name 62744 0
Prof Sean PA Drummond
Address 62744 0
Monash University School of Psychological Sciences,
18 Innovation Walk, Clayton Campus,
Wellington Road, Monash University,
VIC, 3800 Australia
Country 62744 0
Australia
Phone 62744 0
+61 3 9905 3956
Fax 62744 0
Email 62744 0
sean.drummond@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic and relevant clinical data related to baseline symptoms and treatment response
When will data be available (start and end dates)?
Following publication of main outcome data with no end date yet determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Mega-analyses

We did intend to write " mega-analysis". A mega analysis is when a group collects individual level data from multiple studies to conduct large scale analyses not possible in individual studies. This is in contrast to a meta-analysis where results from individual studies are aggregated and summarised.
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2266 0
Study protocol
Citation [1] 2266 0
Link [1] 2266 0
Email [1] 2266 0
Other [1] 2266 0
https://doi.org/10.1186/s13063-019-3334-3
Attachment [1] 2266 0
Summary results
No Results