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 |
| Protocol serial number | 9418 |
| Sponsor | University of Manchester (UK) |
| Funder | National Institutes of Health Research (NIHR) (UK) - Programme for Applied Research; (ref: grant codes: RP-PG-0407-10389) |
- 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
Scientific
Zochonis Building
Brunswick Street, Oxford Road
Manchester
M13 9PL
United Kingdom
| nancy.black@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Bipolar relapse; Timepoint(s): Baseline, 3, 6, 9 and 12 months |
| Key secondary outcome measure(s) |
Alcohol Use and other substance use; Timepoint(s): Baseline, 3, 6, 9 and 12 months |
| Completion date | 06/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
M13 9PL
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 | 01/09/2018 | 18/12/2020 | Yes | No |
| Protocol article | protocol | 08/05/2018 | 18/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2020: Publication references added.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
