Contact information
Type
Scientific
Contact name
Miss Nancy Black
ORCID ID
Contact details
Zochonis Building
Brunswick Street
Oxford Road
Manchester
M13 9PL
United Kingdom
-
nancy.black@nhs.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
9418
Study information
Scientific title
Integrated psychological therapy for people with bipolar disorder (BD) and co-morbid alcohol use: a feasibility randomised trial
Acronym
Study hypothesis
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
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
06/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
Participant 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
Recruitment start date
04/01/2011
Recruitment end date
06/06/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
c/o Mohammed Zubair
Faculty of Medical and Human Sciences
The University of Manchester
Simon Building
Brunswick St
Manchester
M13 9PL
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institutes of Health Research (NIHR) (UK) - Programme for Applied Research; (ref: grant codes: RP-PG-0407-10389)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |