Condition category
Mental and Behavioural Disorders
Date applied
21/10/2008
Date assigned
20/11/2008
Last edited
09/11/2015
Prospective/Retrospective
Prospectively 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 Daniel Smith

ORCID ID

Contact details

Department of Psychological Medicine
Cardiff University School of Medicine
Monmouth House
Heath Park
Cardiff
CF14 4DW
United Kingdom
+44 (0)29 2074 3871
smithdj3@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPON611-08

Study information

Scientific title

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

Acronym

BIPED

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

Interventional

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

Condition

Bipolar disorder

Intervention

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

01/04/2009

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

01/04/2009

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
Cardiff
CF14 4DW
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.cf.ac.uk/

Funders

Funder type

Government

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

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

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19674448
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22017225
3. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26543925

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

09/11/2015: Publication reference added.