ISRCTN ISRCTN50788919
DOI https://doi.org/10.1186/ISRCTN50788919
Protocol serial number 5864
Sponsor University of Oxford (UK)
Funder The Wellcome Trust (UK)
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
11/08/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Catherine Harmer
Scientific

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

Study information

Primary study designInterventional
Study designSingle-centre interventional treatment trial
Secondary study designRandomised controlled trial
Scientific title
Study objectives1. 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(s)MREC approved, ref: 08/H0603/36
Health condition(s) or problem(s) studiedTopic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder
InterventionIntervention - 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/10/2011

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration80
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment13/03/2009
Date of final enrolment01/10/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University Department of Psychiatry
Oxford
OX3 7JX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan