Bipolar Interactive PsychoEDucation trial

ISRCTN	ISRCTN81375447
DOI	https://doi.org/10.1186/ISRCTN81375447
Protocol serial number	SPON611-08
Sponsor	Cardiff University (UK)
Funder	National Institute of Health Research (NIHR) (UK) - postdoctoral fellowship funded by the Welsh Assembly Govenment (ref: CRES4050)

Submission date: 21/10/2008
Registration date: 20/11/2008
Last edited: 05/12/2017

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Smith
Scientific

Department of Psychological Medicine
Cardiff University School of Medicine
Monmouth House, Heath Park
Cardiff
CF14 4DW
United Kingdom

Phone	+44 (0)29 2074 3871
Email	smithdj3@cardiff.ac.uk

Study information

Primary study design	Interventional
Study design	Single site exploratory randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An exploratory (phase II) trial of a novel interactive psychoeducational intervention for bipolar disorder
Study acronym	BIPED
Study objectives	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(s)	Application submitted to South East Wales Research Ethics Committee on 16/10/2008.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key exclusion criteria	Inability to engage fully in the psychoeducational programme (for example, because of cognitive impairment or not having English language of sufficient ability).
Date of first enrolment	01/04/2009
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Psychological Medicine

Cardiff
CF14 4DW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of exploratory trial	01/08/2011		Yes	No
Results article	results	08/07/2015		Yes	No
Protocol article	protocol	12/08/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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