Condition category
Mental and Behavioural Disorders
Date applied
14/05/2018
Date assigned
05/06/2018
Last edited
22/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People with insomnia display a tendency to show increased attention towards cues which are related to sleep (i.e. sleep-related cues). These can be internal in nature (e.g. bodily sensations whilst trying to sleep) or external (checking the clock/time whilst trying to fall asleep). This behaviour in turn leads people with insomnia to feel more anxious about sleep and can actually make the sleep disturbance worse. This study aims to use a computer-based task delivered online (i.e. attentional bias modification) to train such attention away from sleep-related cues.

Who can participate?
Adults with insomnia

What does the study involve?
Participants are randomly allocated to either online attentional bias modification training, or to a standard online attentional bias task (non-treatment). All participants allocated to the non-treatment are offered the attentional bias modification training once the study is complete. The total duration of treatment is 9 days, with follow-up on the 9th and the 16th day (one week after treatment is complete).

What are the possible benefits and risks of participating?
This study has the potential benefit of reducing symptoms of insomnia and the amount of time it takes to fall asleep. No major risks are anticipated with participation in this study. Whilst the experimental computer based task is relatively short, some may find this uncomfortable (e.g. experience of eye strain) due to its repetitive nature.

Where is the study run from?
Sheffield Hallam University (UK)

When is the study starting and how long is it expected to run for?
May 2018 to February 2019

Who is funding the study?
Sheffield Hallam University (UK)

Who is the main contact?
Dr Umair Akram
u.akram@shu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Umair Akram

ORCID ID

Contact details

HC.2.06
Heart of the Campus
Department of Psychology
Sociology and Politics
Sheffield Hallam University
Collegiate Crescent
Sheffield
S10 2BQ
United Kingdom
+44 (0)114 225 3621
u.akram@shu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ER5451619

Study information

Scientific title

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

Acronym

Study hypothesis

This study will examine the efficacy of using attentional bias modification to reduce symptom severity, pre-sleep arousal and sleep onset latency in insomnia. As research in this area is limited, with the evidence based mixed, the trialists offer no a priori hypothesis. Despite the lack of hypothesis, this exploratory study could show therapeutic potential of attentional bias modification for insomnia.

Ethics approval

Sheffield Hallam University Research Ethics Committee, 19/04/2018, ref: ER5451619

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Insomnia disorder

Intervention

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 modification training condition, or to a standard attentional bias task (non-treatment) control condition. Both conditions will be delivered online by a web platform. All participants allocated to the non-treatment control group will be offered ABM training once the study is complete.

Total duration of treatment: 9 days, with follow-up 1 being on the 9th day, follow-up 2 on the 16th (one week after experimental protocol is complete).

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

10/05/2018

Overall trial end date

01/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

10/05/2018

Recruitment end date

05/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Hallam University
Sheffield
s10 2bp
United Kingdom

Sponsor information

Organisation

Sheffield Hallam University

Sponsor details

Department of Psychology
Sociology and Politics
Sheffield Hallam University
Collegiate Crescent
Sheffield
S11 8AH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sheffield Hallam University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Protocol to be submitted with all additional information to the Journal Trials following registration. Planned publication of the study results in a high-impact peer reviewed journal approximately six months following completion of data collection.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Umair Akram (u.akram@shu.ac.uk, u.akram@outlook.com). Data will become available after publication of the final outcomes. This will be in the form of raw data scores for each participant. Participant demographics will be available, however no identifying information will be provided.

Intention to publish date

02/08/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30340627

Publication citations

Additional files

Editorial Notes

22/10/2018: Publication reference added. 25/09/2018: The following changes were made to the trial record: 1. The primary outcome measures were updated. 2. The overall trial end date was updated from 02/02/2019 to 01/05/2019. 3. The recruitment end date was updated from 20/08/2018 to 05/02/2019.