Condition category
Mental and Behavioural Disorders
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
11/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine Harmer

ORCID ID

Contact details

University Department of Psychiatry
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5864

Study information

Scientific title

Acronym

Study hypothesis

1. Do patients with bipolar disorder display an attentional bias towards threat?
2. Can this bias be modified using a simple computer-based intervention?
3. Does modifying the bias lead to changes in the emotional response to stressful situations?

Ethics approval

MREC approved, ref: 08/H0603/36

Study design

Single-centre interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder

Intervention

Intervention - positive attention training: this involves completing a computer-based task on the day of testing. The task requires that particiapnts pay less attention to negative information. Participants complete the task only during the testing session. The task takes approximately 30 minutes to complete.
Control - neutral attention training: this is identical to the intervention task except that the participants are not required to direct their attention away from negative information.

Study entry: registration and one or more randomisations.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Attentional bias as measured using a computerised task (the dot-probe task) on the day of testing

Secondary outcome measures

1. Symptoms of anxiety, measured on a 10-point scale and collected via SMS messaging three times a day for the week following testing
2. Symptoms of low mood (measured using the Positive Affect Negative Affect Schedule [PANAS] scale) and anxiety (measured using the State-Trait Anxiety Inventory [STAI] scale) immediately following testing

Overall trial start date

13/03/2009

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 80; UK sample size: 80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

13/03/2009

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Psychiatry
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes