Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000398909
Ethics application status
Approved
Date submitted
11/06/2019
Date registered
23/03/2020
Date last updated
28/06/2021
Date data sharing statement initially provided
23/03/2020
Date results information initially provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the effectiveness and feasibility of an online Mindfulness program for treatment of insomnia
Scientific title
Examining the effectiveness and feasibility of an online Mindfulness program for treatment of insomnia
Secondary ID [1] 298467 0
None
Universal Trial Number (UTN)
Trial acronym
AMW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 313234 0
Sleep problems 315784 0
Condition category
Condition code
Alternative and Complementary Medicine 311675 311675 0 0
Other alternative and complementary medicine
Mental Health 314071 314071 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-week self-guided online mindfulness and cognitive behavioural therapy program for Insomnia. Participants will receive 1 module per week via an email link for 6 weeks to complete online in their own time. Each module will take 1.5-2 hours, and involves, short readings, videos and activities. Completions, time to complete and number of modules completed will be monitored and recorded.
Intervention code [1] 314707 0
Treatment: Other
Comparator / control treatment
No treatment - wait-list control group

This group will be offered the program free of charge at the end of the study
Control group
Active

Outcomes
Primary outcome [1] 320374 0
Insomnia Severity Index score
Timepoint [1] 320374 0
baseline and 6 weeks
Primary outcome [2] 322784 0
feasibility - program completions as measured by A Mindful Way
Timepoint [2] 322784 0
At the end of the intervention period (6 weeks from baseline)
Secondary outcome [1] 371393 0
total wake time on actigraphy
Timepoint [1] 371393 0
Baseline and 6 weeks
Secondary outcome [2] 371394 0
pre sleep arousal scale
Timepoint [2] 371394 0
Baseline and 6 weeks

Eligibility
Key inclusion criteria
Adults (individuals over 18) with complaints of sleep disturbance at least three nights a week for at least three months, an Insomnia Severity Index score of greater than or equal to
15, who are fluent in English, and able and willing accept and comply with the study protocols.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of or current psychiatric disorders with the exception of anxiety disorders and depressive disorders (e.g. PTSD, psychosis, schizophrenia), other sleep disorders, learning disability, shift workers, travel across time zones within last month, any neurological disorder or inability to complete the study at the judgement of the clinician investigators.

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)
central randomisation by computer
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
Repeated measures ANCOVA comtrolling for baseline Insomnia severity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/05/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
20/04/2020
Date of last data collection
Anticipated
31/08/2020
Actual
30/06/2020
Sample size
Target
40
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303010 0
Self funded/Unfunded
Name [1] 303010 0
Melinda Jackson
Country [1] 303010 0
Australia
Funding source category [2] 304653 0
Commercial sector/Industry
Name [2] 304653 0
A Mindful Way
Country [2] 304653 0
Australia
Primary sponsor type
Individual
Name
Melinda Jackson
Address
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 302984 0
None
Name [1] 302984 0
None
Address [1] 302984 0
None
Country [1] 302984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303561 0
Monash University
Ethics committee address [1] 303561 0
Monash University
Clayton, VIC, 3800
Ethics committee country [1] 303561 0
Australia
Date submitted for ethics approval [1] 303561 0
04/03/2019
Approval date [1] 303561 0
27/03/2019
Ethics approval number [1] 303561 0
18774

Summary
Brief summary
Insomnia is one of the most prevalent sleep disorders. The symptoms include difficulties getting to sleep, difficulties staying asleep, or early-morning awakenings with an inability to return to sleep. Insomnia may also be associated with problems with memory and attention, and increased feelings of depression, anxiety and stress. Insomnia can be treated effectively without medication. However, there remains a large proportion of individuals who do not seek help possibly due to barriers such as geographical location or time constraints.

This project will investigate the efficacy and feasibility of an online mindfulness-based insomnia therapy program for people with difficulties getting to sleep or difficulties staying asleep. The study will also examine whether online mindfulness-based insomnia therapy improves objective sleep measures and reduces insomnia symptoms compared to a waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94090 0
Dr Melinda Jackson
Address 94090 0
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country 94090 0
Australia
Phone 94090 0
+61 3 99050206
Fax 94090 0
Email 94090 0
[email protected]
Contact person for public queries
Name 94091 0
Dr Melinda Jackson
Address 94091 0
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country 94091 0
Australia
Phone 94091 0
+61 3 99050206
Fax 94091 0
Email 94091 0
[email protected]
Contact person for scientific queries
Name 94092 0
Dr Melinda Jackson
Address 94092 0
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800
Country 94092 0
Australia
Phone 94092 0
+61 3 99050206
Fax 94092 0
Email 94092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 377758-(Uploaded-22-12-2020-09-20-33)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.