Integrated psychological therapy for people with bipolar disorder (BD) and co-morbid alcohol use: a feasibility randomised trial

ISRCTN	ISRCTN14774583
DOI	https://doi.org/10.1186/ISRCTN14774583
Secondary identifying numbers	9418

Submission date: 14/03/2011
Registration date: 14/03/2011
Last edited: 18/12/2020

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

Miss Nancy Black
Scientific

Zochonis Building
Brunswick Street, Oxford Road
Manchester
M13 9PL
United Kingdom

Email	nancy.black@nhs.net

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Integrated psychological therapy for people with bipolar disorder (BD) and co-morbid alcohol use: a feasibility randomised trial
Study objectives	This study is part of the NIHR funded PARADES programme (Psychoeducation Anxiety Relapse Advance Directives Evaluation & Suicidality). The PARADES programme runs over 5 years in collaboration with Manchester Mental Health and Social Care Trust, Nottingham and Manchester Universities and aims to investigate bipolar disorder and its associated problems and comorbidities. The programme consists of 5 separate studies running in parallel, of which this project is one. This study is the final phase of a treatment development study which aims to evaluate the potential benefits of a time limited psychological intervention for alcohol use in bipolar disorder. The intervention was developed in earlier work by the group including phase 1 (an investigation of the reasons for substance use in bipolar individuals; phase 2 (focus group sessions with service users and mental health professionals to develop and finalise the intervention) and a pilot study of the MICBT intervention with 5 service users (Jones et al in press). More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9418
Ethics approval(s)	North West 9 REC - Greater Manchester West (10/H1014/75) approved on 11/11/2010
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder
Intervention	MI-CBT, The intervention is a time limited, psychological intervention incorporating Motivational interviewing (MI) and Cognitive Behaviour Therapy (CBT) for alcohol use in bipolar disorder. The intervention was developed by a Manchester based group headed by CB for people with substance abuse and psychosis (Barrowclough et al, 2005). Initial sessions will focus on engagement and use motivational interviewing to develop a shared understanding of the clients key life goals and concerns; to elicit and select; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Bipolar relapse; Timepoint(s): Baseline, 3, 6, 9 and 12 months
Secondary outcome measures	Alcohol Use and other substance use; Timepoint(s): Baseline, 3, 6, 9 and 12 months
Overall study start date	04/01/2011
Completion date	06/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 48; UK Sample Size: 48
Key inclusion criteria	1. Primary Diagnosis of Bipolar disorder I or II 2. Current alcohol use (a score of 8 or more on the Alcohol Use Disorders Identification Test, AUDIT) 3. In current contact with mental health services 4. Age 18 years or older 5. An ability to provide informed consent 6. Having a fixed abode.; Target Gender: Male & Female ; lower age limit 18 years
Key exclusion criteria	1. Evidence of organic brain disease, significant concurrent physical illness or learning disability 2. Presence of current manic, hypomanic, mixed affective or major depressive episode currently or within 4 weeks of initial assessment 3. An inability to communicate in written and verbal English
Date of first enrolment	04/01/2011
Date of final enrolment	06/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

c/o Mohammed Zubair
Faculty of Medical and Human Sciences
The University of Manchester
Simon Building, Brunswick St
Manchester
M13 9PL
England
United Kingdom

"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

National Institutes of Health Research (NIHR) (UK) - Programme for Applied Research; (ref: grant codes: RP-PG-0407-10389)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/05/2018	18/12/2020	Yes	No
Results article	results	01/09/2018	18/12/2020	Yes	No

Editorial Notes

18/12/2020: Publication references added.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.