An exploratory randomised controlled trial of a CBT-based recovery intervention for early bipolar disorder
ISRCTN | ISRCTN43062149 |
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DOI | https://doi.org/10.1186/ISRCTN43062149 |
Secondary identifying numbers | 8950 |
- Submission date
- 08/04/2011
- Registration date
- 08/04/2011
- Last edited
- 26/09/2018
- 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 Heather Law
Scientific
Scientific
Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Study information
Study design | Randomised Interventiona; Design type: Treatment |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
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 | An exploratory randomised controlled trial of a CBT-based recovery intervention for early bipolar disorder |
Study objectives | A rater blind randomised controlled trial is proposed. As this is an exploratory trial we wish to determine effect sizes for the primary and secondary outcome measures to inform the development of a definitive study. Primary outcomes are time to bipolar relapse and self reported recovery score. Secondary outcomes are levels of affective and psychotic symptoms, level of functioning and levels depressive and hypomanic appraisal style. |
Ethics approval(s) | 10/H1014/60 |
Health condition(s) or problem(s) studied | Bipolar affective disorder |
Intervention | 1. Recovery focussed CBT 2. The intervention has been developed through collaboration between a multidisciplinary group of mental health professionals and service users with experience of bipolar disorder 3. Focus groups have taken place with individuals who took part in the first phase of the project (the qualitative analysis of recovery themes) to ensure that the intervention is appropriate and acceptable to individuals early in the course of bipolar disorder 4. Furthermore, a service user consultation group have also been provided 5. Follow Up Length: 12 month(s) 6. Study Entry : Single Randomisation only |
Intervention type | Other |
Primary outcome measure | 1. Time to bipolar relapse 2. Timepoint(s): assessed every 3 months from baseline |
Secondary outcome measures | 1. Beck Depression Inventory score - Timepoint(s): baseline, 6 months, 12 months, 18 months 2. Hamilton depression rating scale score - Timepoint(s): baseline, 6 months, 12 months, 18 months 3. Hypomanic Interpretations Questionnaire - Timepoint(s): baseline, 6 months, 12 months, 18 months 4. Internal States Scale score - Timepoint(s): baseline, 6 months, 12 months, 18 months 5. Interpretation of Depression Questionnaire - Timepoint(s): baseline, 6 months, 12 months, 18 months 6. Mania Rating Scale - Timepoint(s): baseline, 6 months, 12 months, 18 months 7. Personal and Social Performance Scale - Timepoint(s): baseline, 6 months, 12 months, 18 months; 8. Post Traumatic Growth Inventory - Timepoint(s): baseline, 6 months, 12 months, 18 months 9. Self reported recovery score - Timepoint(s): baseline and every 6 months; 10. Self-Esteem Rating Scale (Short Form) - Timepoint(s): baseline, 6 months, 12 months, 18 months 11. The Brief Quality of Life in Bipolar Disorder - Timepoint(s): baseline, 6 months, 12 months, 18 months |
Overall study start date | 09/02/2011 |
Completion date | 30/11/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 72; UK Sample Size: 72 |
Key inclusion criteria | 1. Individuals who have received a clinical diagnosis of bipolar disorder or who have experienced a first episode of mania within the last 5 years 2. Aged between 18-65 3. Can provide written informed consent 4. Can communicate in English 5. Target Gender: Male & Female |
Key exclusion criteria | 1. Individuals who are currently experiencing or have experienced within the last month, an acute episode of major depression or mania 2. Individuals referred into the study during an acute episode will wait until they have been out of episode for one month before entering the study. Nevertheless, it is expected that most participants will have subsyndromal mood symptoms. |
Date of first enrolment | 09/02/2011 |
Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology Department
Manchester
M25 3BL
United Kingdom
M25 3BL
United Kingdom
Sponsor information
Lancaster University (UK)
University/education
University/education
Bailrigg
Lancaster
LA1 4YB
England
United Kingdom
Website | http://www.physics.lancs.ac.uk/ |
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https://ror.org/04f2nsd36 |
Funders
Funder type
Government
National Institute for Health Research (NIHR); Grant Codes: RP-PG-0606-1086
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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? |
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Protocol article | protocol | 21/11/2012 | Yes | No | |
Results article | results | 01/01/2015 | Yes | No |
Editorial Notes
26/09/2018: Publication reference added.