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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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5 January 2021 |
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Main ID: |
ISRCTN14774583 |
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Date of registration:
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14/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Integrated psychological therapy for people with bipolar disorder (BD) and co-morbid alcohol use: a feasibility randomised trial
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Scientific title:
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Integrated psychological therapy for people with bipolar disorder (BD) and co-morbid alcohol use: a feasibility randomised trial |
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Date of first enrolment:
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04/01/2011 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14774583 |
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Study type:
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Interventional |
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Study design:
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Randomised; Interventional; Design type: Treatment (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Nancy
Black |
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Address:
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Zochonis Building
Brunswick Street, Oxford Road
M13 9PL
Manchester
United Kingdom |
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Telephone:
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- |
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Email:
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nancy.black@nhs.net |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder
Mental and Behavioural Disorders
Bipolar disorder
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Intervention(s)
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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
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Primary Outcome(s)
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Bipolar relapse; Timepoint(s): Baseline, 3, 6, 9 and 12 months
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Secondary Outcome(s)
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Alcohol Use and other substance use; Timepoint(s): Baseline, 3, 6, 9 and 12 months
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Source(s) of Monetary Support
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National Institutes of Health Research (NIHR) (UK) - Programme for Applied Research; (ref: grant codes: RP-PG-0407-10389)
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Ethics review
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Status:
Approval date:
Contact:
North West 9 REC - Greater Manchester West (10/H1014/75) approved on 11/11/2010
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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06/06/2012 |
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URL:
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