Condition category
Mental and Behavioural Disorders
Date applied
14/03/2011
Date assigned
14/03/2011
Last edited
11/06/2015
Prospective/Retrospective
Retrospectively 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

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 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

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

Trial setting

Other

Trial 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 client’s key life goals and concerns; to elicit and select; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/01/2011

Overall trial end date

06/06/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes