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Trial registered on ANZCTR


Registration number
ACTRN12616000346471
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
17/03/2016
Date last updated
13/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can attention training improve sleep, anxiety, and mood?
Scientific title
A double-blinded randomised controlled trial of attentional bias modification for insomnia
Secondary ID [1] 288630 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 297830 0
Anxiety 297831 0
Depression 297832 0
Condition category
Condition code
Mental Health 298003 298003 0 0
Anxiety
Mental Health 298004 298004 0 0
Depression
Mental Health 298005 298005 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attentional bias modification (ABM) intervention with 5 sessions completed over 5 nights before bed at home (1 x approx, 15 minute session/day).

Each ABM session consists of delivery of 384 trials using 48 word pairs comprising sleep-related threat words (e.g. Agitated, Exhausted) paired with length and frequency-matched non-threat words (e.g. Carriers, Developed),

Each trial of the task will begin with a fixation cross in the centre of the computer screen for 500ms. A word pair will then appear for 500ms. Immediately following this, a visual probe comprising of two small red dots oriented either horizontally (..) or vertically (:) will appear in the location on the screen of one of the words previously shown. On each trial, participants will be required to indicate which of the two probes was shown by pressing the corresponding buttons on the keyboard or screen. The probes will appear on the screen location previously occupied by the non-threat words 100% of the time.

Adherence to the daily ABM sessions will be automatically tracked by the computer program. Standardised email reminders will be sent to a participant each day.
Intervention code [1] 294064 0
Treatment: Other
Comparator / control treatment
Attentional bias modification intervention with 5 sessions completed over 5 nights before bed at home (1 x approx, 15 minute session/day).

Each ABM session consists of delivery of 384 trials using 48 word pairs comprising sleep-related threat words (e.g. Agitated, Exhausted) paired with length and frequency-matched non-threat words (e.g. Carriers, Developed),

Each trial of the probe task will begin with a fixation cross in the centre of the computer screen for 500ms. A word pair will then appear for 500ms. Immediately following this, a visual probe comprising of two small red dots oriented either horizontally (..) or vertically (:) will appear in the location on the screen of one of the words previously shown. On each trial, participants will be required to indicate which of the two probes was shown by pressing the corresponding buttons on the keyboard or screen. The probes will appear on the screen location previously occupied by the non-threat words 50% of the time, and on the screen location previously occupied by the threat word 50% of the time.

Adherence to the daily ABM sessions will be automatically tracked by the computer program. Standardised email reminders will be sent to a participant each day.
Control group
Active

Outcomes
Primary outcome [1] 297519 0
Changes in insomnia symptoms according to scores on the Insomnia Severity Index (ISI)
Timepoint [1] 297519 0
Administered at Baseline (T1), Post-ABM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [1] 321283 0
Changes in anxiety symptoms according to scores on the Generalised Anxiety Disorder 7-item scale (GAD-7)
Timepoint [1] 321283 0
Administered at Baseline (T1), Post-ABM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [2] 321284 0
Changes in depression symptoms according to scores on the Patient Health Questionnaire 9-item scale (PHQ-9)
Timepoint [2] 321284 0
Administered at Baseline (T1), Post-ABM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [3] 321290 0
Changes in sleep quality according to scores on the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 321290 0
Administered at Baseline (T1), Post-ABM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [4] 321291 0
Changes in worry frequency according to scores on the Penn State Worry Questionnaire 3-item version (PSWQ-3)
Timepoint [4] 321291 0
Administered at Baseline (T1), Post-ABM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [5] 321292 0
Changes in insomnia-related anxiety according to scores on the Anxiety and Preoccupation about Sleep Questionnaire (ASPQ)
Timepoint [5] 321292 0
Administered at Baseline (T1) and Post-ABM intervention (T2, 1 week after baseline)
Secondary outcome [6] 321293 0
Changes in pre-sleep arousal according to scores on the cognitive subscale of the Pre-Sleep Arousal Scale (PSAS-C)
Timepoint [6] 321293 0
Administered daily for one week during ABM intervention
Secondary outcome [7] 321332 0
Self-reported sleep parameters such as total sleep time (TST), time in bed (TIB), wake after sleep onset (WASO), sleep onset latency (SOL), sleep efficiency (SE), and sleep quality as measured by sleep diary.
Timepoint [7] 321332 0
Administered daily for one week during ABM intervention

Eligibility
Key inclusion criteria
- Self-identified as suffering from insomnia and anxiety/depression, with worry as a contributing factor to their insomnia.
- Meet criteria for insomnia on ISI and time frames outlined in DSM-5.
- Meet threshold for Generalised Anxiety Disorder on GAD-7, or meet threshold for depression on PHQ-9, without thoughts of self-harm/suicidal intent.
- Australian resident status.
- At least 18 years of age.
- Have reliable access to a computer and the internet.
- Prepared to provide name, phone number, and address, and to provide the name and phone number of a local general practitioner.
- Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of severe depression and/or suicidal ideation.
- Lifetime history of psychosis/bipolar disorder.
- Current substance abuse/use of Benzodiazepines or antipsychotic medications.
- Presence of untreated sleep disorder other than insomnia.
- Initiation/change of medication, or initiation of psychological therapy in the last 2 months.
- Engagement in shift work/presence of commitments that interfere with regular night-time sleep patterns.
- Waking time outside of 4-10am and bed time outside of 8pm-2pm more than twice a week, not primarily due to insomnia.
- Not fluent in written and spoken English.

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)
Participants apply online and eligibility is assessed via online screening questionnaires. Those who meet the inclusion criteria will be asked to enter basic demographic information over the internet, read the information sheet and return an electronic consent form to the investigators. They will then be randomly allocated to one of the two conditions, determined automatically through the ABM training program and therefore neither the investigators nor participants are aware of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a number generated at first log-in to the study and allocated to either group at a 1:1 ratio. An off-site staff member not involved in the clinical trial will allocate either odd or even participant numbers to either condition and keep this decision from the investigators and participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
On the basis of previous studies we anticipate a between-groups effect size difference of 0.8 on the primary outcome. To detect this difference, we will recruit 66 participants, which will have 80% power (at 95% significance level) to detect this difference, taking into account attrition.

Mixed ANOVA will be used to evaluate the data collected, with time as the within-subjects factor and group as the between-subjects factor.

Recruitment
Recruitment status
Completed
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293007 0
Hospital
Name [1] 293007 0
St Vincent's Hospital Sydney
Address [1] 293007 0
390 Victoria St Darlinghurst NSW 2010
Country [1] 293007 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 291785 0
None
Name [1] 291785 0
Address [1] 291785 0
Country [1] 291785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294516 0
St. Vincent's Hospital HREC
Ethics committee address [1] 294516 0
St. Vincent's Hospital
394-404 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 294516 0
Australia
Date submitted for ethics approval [1] 294516 0
20/01/2016
Approval date [1] 294516 0
04/02/2016
Ethics approval number [1] 294516 0
HREC/14/SVH/27

Summary
Brief summary
This RCT will evaluate the acceptability and efficacy of a multi-day online ABM program targeting insomnia symptoms by comparing an active ABM intervention with a control ABM task. It will also examine whether improvements in insomnia lead to reduction in comorbid anxiety/depression symptoms and appraise the longer-term therapeutic effects of ABM on insomnia and comorbid anxiety/depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63926 0
Prof Gavin Andrews
Address 63926 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, O’Brien Centre, St Vincent’s Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 63926 0
Australia
Phone 63926 0
+61 2 8382 1405
Fax 63926 0
Email 63926 0
gavina@unsw.edu.au
Contact person for public queries
Name 63927 0
Dr Elizabeth Mason
Address 63927 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, O’Brien Centre, St Vincent’s Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 63927 0
Australia
Phone 63927 0
+61 2 8382 1400
Fax 63927 0
Email 63927 0
elizabeth.mason@svha.org.au
Contact person for scientific queries
Name 63928 0
Dr Elizabeth Mason
Address 63928 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, O’Brien Centre, St Vincent’s Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 63928 0
Australia
Phone 63928 0
+61 2 8382 1400
Fax 63928 0
Email 63928 0
elizabeth.mason@svha.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary