Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000683730
Ethics application status
Approved
Date submitted
30/04/2022
Date registered
11/05/2022
Date last updated
13/04/2023
Date data sharing statement initially provided
11/05/2022
Date results information initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Open-Label Placebo Sleep Study for Insomnia
Scientific title
Can open-label placebos (OLP) augment an existing online treatment for insomnia in adults?
Secondary ID [1] 307030 0
Nil Known
Universal Trial Number (UTN)
U1111-1277-8832
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 326173 0
Condition category
Condition code
Mental Health 323481 323481 0 0
Other mental health disorders
Neurological 323517 323517 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be one face-to-face session (1 x 30 minutes) for all participants with the researcher. In this session, participants will be randomly assigned to one of three treatment groups;

Arm 1:
The first group will be given access to the SHUTi (Sleep Healthy Using the Internet) online treatment program. SHUT-i is an interactive and tailored web-based program that requires participants to complete a weekly 25-40 minute module for six weeks. These modules include 1) Psychoeducation, 2) sleep restriction, 3) stimulus control, 4) cognitive restructuring, 5) sleep hygiene and 6) relapse prevention. These modules are based on the well-established face-to-face cognitive behavioural therapy for insomnia (CBT-i). Adherence will be monitored by website analytics and module completion data.

Participants in this group will also receive a 20mL plastic bottle labelled ‘Placebos’ containing 84 placebo tablets, with instructions to take two tablets every night before sleep. A placebo tablet is an inert or inactive tablet that does not contain any active drug ingredient. The placebo tablets are composed of microcrystalline cellulose which is an inert substance. Adherence will be measured by asking participants how many tablets they have left at the end of their intervention period.

Arm 2:
The second group will be given access to the SHUTi (Sleep Healthy Using the Internet) online treatment program only. SHUT-i is an interactive and tailored web-based program that requires participants to complete a weekly 25-40 minute module for six weeks. These modules include 1) Psychoeducation, 2) sleep restriction, 3) stimulus control, 4) cognitive restructuring, 5) sleep hygiene and 6) relapse prevention. These modules are based on the well-established face-to-face cognitive behavioural therapy for insomnia (CBT-i). Adherence will be monitored by website analytics and module completion data.
Intervention code [1] 323482 0
Behaviour
Intervention code [2] 323519 0
Treatment: Other
Comparator / control treatment
Waitlist Control Group:
The waitlist control group will receive online sleep health patient education (PE) supplied by the Centre for Behavioural Health & Technology at University of Virginia School of Medicine. The PE program will include fixed material about the effect, prevalence, and causes of insomnia and will take approximately 20-30 to read. Participants in this group will be required to read this material once. The waitlist control group will be given full access to SHUT-i at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 331226 0
Insomnia Severity (ISI) Score
Timepoint [1] 331226 0
Post Intervention (immediately after completion of the 6 core SHUT-i programmes).
Primary outcome [2] 331227 0
Self-Assessment of Sleep Survey (SASS-Y) Score
Timepoint [2] 331227 0
Post-intervention (immediately after completion of the 6 core SHUT-i programmes).
Secondary outcome [1] 409239 0
Adherence to Sleep Healthy Using the Internet (SHUTi). Adherence will be assessed by looking at the website analytics from the Sleep Healthy Using the Internet (SHUTi) web-based programme.
Timepoint [1] 409239 0
Post-intervention (immediately after completion of the 6 core SHUT-i programmes).

Eligibility
Key inclusion criteria
Inclusion criteria
To participate, individuals must:
1.Reported Insomnia Severity Index (ISI) score of >7.
2.Have ability to read/speak English.
3.Be 18 years and older.
4.Have Internet access, computer access and an active email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Participants will be excluded from the study if they:
1.Have irregular sleep schedules that prevent the ability to follow intervention recommendations including night shift work, bedtimes outside of 8pm-2am or awakenings outside of 4am-10am.
2.Have uncontrolled or certain medical conditions deemed to interfere with the study procedures or put the participant at undue risk. 3.Are pregnant.
4.Have current psychological treatment for insomnia.
5.Are currently taking medications that interfere with sleep e.g. Steroids, Dexedrine, Ritalin, Adderall, and Provigil.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
A power analysis was conducted with G*Power to calculate the required sample size to ensure significance. Based on a previous meta-analysis examining the effects of open-label placebos in clinical trials (von Wernsdorf et al., 2021), we expect a medium to large effect size (d=0.72). Using 80% power and an alpha level of 0.05 requires a sample size of 64 participants. 22 participants would be selected for each group to ensure adequate sample size. To allow for a dropout of approximately 25% we will recruit 30 participants in each group and a total sample of 90 participants.

One-way ANOVA will be used to evaluate the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2022
Actual
20/05/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
29/07/2022
Date of last data collection
Anticipated
30/09/2022
Actual
7/10/2022
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 24741 0
New Zealand
State/province [1] 24741 0
Auckland

Funding & Sponsors
Funding source category [1] 311343 0
University
Name [1] 311343 0
The University of Auckland
Country [1] 311343 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road, Grafton, Auckland, New Zealand, 1023
Country
New Zealand
Secondary sponsor category [1] 312721 0
None
Name [1] 312721 0
Address [1] 312721 0
Country [1] 312721 0
Other collaborator category [1] 282273 0
Individual
Name [1] 282273 0
Professor Keith Petrie
Address [1] 282273 0
The University of Auckland
M&HS BUILDING 503 - Bldg 503
Level 3, Room 320
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country [1] 282273 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310838 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 310838 0
24 Symonds Street, Auckland, New Zealand, 1010
Ethics committee country [1] 310838 0
New Zealand
Date submitted for ethics approval [1] 310838 0
25/02/2022
Approval date [1] 310838 0
20/04/2022
Ethics approval number [1] 310838 0
AH23724

Summary
Brief summary
The present study will examine whether open-label placebos (OLP) can enhance an existing online treatment for insomnia. OLP involves administering a placebo treatment with full disclosure that the treatment is, in fact, a placebo. The absence of deception in OLP may enable patients to receive the benefits of placebos without violating informed consent.

Our primary hypothesis is that participants who receive the OLP augmented treatment (SHUTi+OLP) will show greater improvements in subjective sleep parameters, sleep quality and self-reported insomnia symptoms, compared with standard treatment groups. Furthermore, it is also hypothesised that the SHUTi+OLP group will show greater adherence to digital internet treatment compared with the SHUT-i only group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119046 0
Prof Keith Petrie
Address 119046 0
The University of Auckland
M&HS BUILDING 503
Level 3, Room 320
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 119046 0
New Zealand
Phone 119046 0
+649 923 6564
Fax 119046 0
Email 119046 0
kj.petrie@auckland.ac.nz
Contact person for public queries
Name 119047 0
Prof Keith Petrie
Address 119047 0
The University of Auckland
M&HS BUILDING 503
Level 3, Room 320
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 119047 0
New Zealand
Phone 119047 0
+649 923 6564
Fax 119047 0
Email 119047 0
kj.petrie@auckland.ac.nz
Contact person for scientific queries
Name 119048 0
Prof Keith Petrie
Address 119048 0
The University of Auckland
M&HS BUILDING 503
Level 3, Room 320
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 119048 0
New Zealand
Phone 119048 0
+649 923 6564
Fax 119048 0
Email 119048 0
kj.petrie@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not intend to share any identifiable data. Only the research team will have access to this information.


What supporting documents are/will be available?




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.