Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Daniel Smith


Contact details

Department of Psychological Medicine
Cardiff University School of Medicine
Monmouth House
Heath Park
CF14 4DW
United Kingdom
+44 (0)29 2074 3871

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An exploratory (phase II) trial of a novel interactive psychoeducational intervention for bipolar disorder



Study hypothesis

The aim of this study is to conduct an exploratory (phase II) trial of a novel interactive psychoeducational intervention for bipolar disorder. The objective of the trial is to assess the efficacy of the intervention in terms of impact on quality of life, levels of psychosocial functioning and experiences of both depressive and manic symptoms.

Ethics approval

Application submitted to South East Wales Research Ethics Committee on 16/10/2008.

Study design

Single site exploratory randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

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


Bipolar disorder


BEATING BIPOLAR is a novel interactive psychoeducational intervention. It involves a blending of different delivery mechanisms, with initial face-to-face delivery to focus on engagement, followed by written and web-based interactive delivery of factual content. The online content requires the reader to be engaged in a number of interactive exercises which maximise long-term retention of the material.

The key areas covered in the package are:
1. The accurate diagnosis of bipolar disorder
2. The causes of bipolar disorder
3. The role of medication
4. The role of lifestyle changes
5. Relapse prevention and early intervention
6. Psychological approaches
7. Gender-specific considerations
8. Advice for family and carers

The eight modules are delivered online on a fortnightly basis over a four-month period. There is an initial face-to-face introductory meeting with participants and each module is discussed within an online discussion forum for participants. This forum will facilitate peer support and will allow us to provide clarification of module content, answer questions from participants and provide on-going support with engagement. The online forum will also be important in terms of assessing the acceptability of the intervention.

The control group will received treatment as usual. The intervention will begin within 2 weeks of randomisation and treatment will last for 4 months. Outcome assessments for this study will occur 6 months after the end of the intervention.

Intervention type



Not Specified

Drug names

Primary outcome measure

Quality of life, assessed using the World Health Organization Quality of Life Questionnaire (WHOQOL-Bref). Outcome assessments will occur 6 months after the end of the intervention.

Secondary outcome measures

1. Global Assessment of Functioning (GAF) scores
2. Functioning Assessment Short Test (FAST) scores
3. Schedule of Assessment of Insight (SAI) scores
4. Current depressive symptoms according to the Montgomery-Asberg Depression Rating Scale (MADRS) and current manic symptoms according to the Young Mania Rating Scale (YMRS) scale
5. All participants will be re-assessed using the Mini International Neuropsychiatric Interview (MINI) applied to the 6 month follow-up period in order to obtain information about the number and severity of depressive and manic symptoms and number of episodes of depression and mania or hypomania experienced during this follow-up period
6. Cost-effectiveness analysis of the intervention

Outcome assessments will occur 6 months after the end of the intervention.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria of bipolar disorder (including type I and type II)
2. Male and female
3. Aged between 18 - 65 years

Participant type


Age group




Target number of participants


Participant exclusion criteria

Inability to engage fully in the psychoeducational programme (for example, because of cognitive impairment or not having English language of sufficient ability).

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
CF14 4DW
United Kingdom

Sponsor information


Cardiff University (UK)

Sponsor details

c/o Dr Kathryn Pittard Davies
Research and Commercial Division
30 - 36 Newport Road
CF24 0DE
United Kingdom

Sponsor type




Funder type


Funder name

National Institute of Health Research (NIHR) (UK) - postdoctoral fellowship funded by the Welsh Assembly Govenment (ref: CRES4050)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2009 protocol in
2. 2011 results of exploratory trial in
3. 2015 results in

Publication citations

  1. Results

    Smith DJ, Griffiths E, Poole R, di Florio A, Barnes E, Kelly MJ, Craddock N, Hood K, Simpson S, Beating Bipolar: exploratory trial of a novel Internet-based psychoeducational treatment for bipolar disorder., Bipolar Disord, 13, 5-6, 571-577, doi: 10.1111/j.1399-5618.2011.00949.x.

  2. Simpson S, Barnes E, Griffiths E, Hood K, Cohen D, Craddock N, Jones I, Smith DJ, The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol., BMC Psychiatry, 2009, 9, 50, doi: 10.1186/1471-244X-9-50.

Additional files

Editorial Notes

05/12/2017: internal review. 09/11/2015: Publication reference added.