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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

22/10/2021

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]

Nil

Universal Trial Number (UTN)

Trial acronym

REST

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insomnia Disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Neurological

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]

Behaviour

Intervention code [2]

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]

A primary outcome is adherence to Stimulus Control as assessed by the sleep diary.

Timepoint [1]

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]

A primary outcome is adherence to Sleep Restriction as assessed by the sleep diary.

Timepoint [2]

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]

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]

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]

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]

The primary timepoints are before treatment (baseline), immediately following the last treatment session, and six months after the last treatment session,

Secondary outcome [2]

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]

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]

Psychiatric symptoms - depression. This is operationalised by scores on the Patient Health Questionnaire-9.

Timepoint [3]

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]

Psychiatric symptoms - anxiety. This is operationalised by scores on the Beck Anxiety Inventory.

Timepoint [4]

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]

Quality of Life. This is operationalized by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form.

Timepoint [5]

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]

Another secondary outcome is bed partners' sleep-wake patterns and problems. This is operationalised by activity recorded via sleep diaries.

Timepoint [6]

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]

The bed partners' sleep-wake patterns and problems as assessed with actigraphy.

Timepoint [7]

Secondary outcome [8]

The bed partner's insomnia symptoms as assessed with the Insomnia Severity Index.

Timepoint [8]

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]

Client sleep-diary sleep efficiency

Timepoint [9]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

1/06/2016

Actual

29/07/2016

Date of last participant enrolment

Anticipated

1/08/2019

Actual

18/11/2019

Date of last data collection

Anticipated

1/02/2020

Actual

26/05/2020

Sample size

Target

120

Accrual to date

Final

117

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1 16 Marcus Clarke Street Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committees (MUHREC)

Ethics committee address [1]

First Floor, Room 111
Chancellery Building E 
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2016

Approval date [1]

18/03/2016

Ethics approval number [1]

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

Prof Sean PA Drummond

Address

Monash University School of Psychological Sciences, 18 Innovation Walk, Clayton Campus, Wellington Road, Monash University, VIC, 3800 Australia

Country

Australia

Phone

+61 3 9905 3956

Fax

[email protected]

Contact person for public queries

Name

Alix Mellor

Address

Sleep and Circadian Medicine Laboratory Be Active Sleep Eat Facility 264 Ferntree Gully Road, Monash University, Notting Hill VIC 3168, Australia

Country

Australia

Phone

+61 3 99055912

Fax

[email protected]

Contact person for scientific queries

Name

Sean PA Drummond

Address

Monash University School of Psychological Sciences, 18 Innovation Walk, Clayton Campus, Wellington Road, Monash University, VIC, 3800 Australia

Country

Australia

Phone

+61 3 9905 3956

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• Demographic and relevant clinical data related to baseline symptoms and treatment response

What types of analyses could be done with individual participant data?

• 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.

When can requests for individual participant data be made (start and end dates)?

From:
Following publication of main outcome data with no end date yet determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2266	Study protocol		https://doi.org/10.1186/s13063-019-3334-3
12025	Ethical approval					Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Partner-assisted cognitive behavioural therapy for insomnia versus cognitive behavioural therapy for insomnia: A randomised controlled trial.	2019	https://dx.doi.org/10.1186/s13063-019-3334-3
Dimensions AI	Validity, potential clinical utility and comparison of a consumer activity tracker and a research-grade activity tracker in insomnia disorder II: Outside the laboratory	2019	https://doi.org/10.1111/jsr.12944
Embase	Anxiety predicts dyadic sleep characteristics in couples experiencing insomnia but not in couples without sleep disorders.	2020	https://dx.doi.org/10.1016/j.jad.2020.04.031
Embase	Sleep and wake are shared and transmitted between individuals with insomnia and their bed-sharing partners.	2020	https://dx.doi.org/10.1093/sleep/zsz206
Dimensions AI	Differentiating acute from chronic insomnia with machine learning from actigraphy time series data	2022	https://doi.org/10.3389/fnetp.2022.1036832

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically