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Examining the efficacy of attentional bias re-training in reducing pre-sleep cognitive arousal and insomnia symptoms

A randomised controlled trial to examine the therapeutic potential of attentional bias modification training for insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11643569
Enrollment
90
Registered
2018-06-05
Start date
2018-05-10
Completion date
Unknown
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder Mental and Behavioural Disorders

Interventions

This study will use a simple randomisation with an allocation ratio of 1:1 which will be carried out by the automated online system. Participants will be randomised to an online attentional bias modif

Sponsors

Sheffield Hallam University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult members from the general population who meet the DSM-5 criteria for Insomnia Disorder 2. Dissatisfaction with sleep characterized by either a difficulty initiating or maintaining sleep or early morning awakenings 3. Insomnia should be present for three or more nights per week, for at least three months, and cause significant daytime impairment 4. These conditions must be met despite an adequate opportunity to sleep

Exclusion criteria

Exclusion criteria: 1. Symptoms of a sleep/wake disorder other than insomnia 2. Existing psychiatric illness 3. Central nervous system disorder 4. Use of medication that may affect sleep 5. Prior head injury 6. Current shift-work

Design outcomes

Primary

MeasureTime frame
Primary outcome measure as of 25/09/2018: 1. Sleep-related attentional bias (i.e. vigilance, disengagement) assessed using a dot-probe task consisting of sleep-negative and neutral words at baseline (day1) and then again on day 9 2. Insomnia severity measured by the Insomnia Severity Index at baseline (day 1), on completion of experimental protocol (day 9), and on day 16 3. Sleep onset latency measured by a sleep diary at baseline (day 1) and on completion of experimental protocol (day 9) 4. Pre-sleep cognitive arousal measured by the Pre-Sleep Cognitive Arousal Scale prior to sleep on days where the experiment will be administered (days 3-7) Previous primary outcome measure: 1. Sleep-related attentional bias (i.e. vigilance, disengagement) assessed using a dot-probe task consisting of sleep-negative and neutral words at baseline (day1) and then again on day 9 2. Insomnia severity measured by the Insomnia Severity Index at baseline (day 1), on completion of experimental protocol (day 9), and on day 16 3. Sleep onset latency measured by a sleep diary at baseline (day 1) and on completion of experimental protocol (day 9) 4. Pre-sleep cognitive arousal measured by the Pre-Sleep Cognitive Arousal Scale prior to sleep on days where the experiment will be administered (day 3, 5 and 7)

Secondary

MeasureTime frame
Safety and monitoring behavior, assessed using the SAMI at baseline (day 1), 9 and 16

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026