An exploratory randomised controlled trial of a CBT-based recovery intervention for early bipolar disorder

ISRCTN ISRCTN43062149
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

Psychology Department
Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Study information

Study designRandomised Interventiona; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn exploratory randomised controlled trial of a CBT-based recovery intervention for early bipolar disorder
Study objectivesA 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) studiedBipolar affective disorder
Intervention1. 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 typeOther
Primary outcome measure1. Time to bipolar relapse
2. Timepoint(s): assessed every 3 months from baseline
Secondary outcome measures1. 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 date09/02/2011
Completion date30/11/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsPlanned Sample Size: 72; UK Sample Size: 72
Key inclusion criteria1. 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 criteria1. 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 enrolment09/02/2011
Date of final enrolment30/11/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychology Department
Manchester
M25 3BL
United Kingdom

Sponsor information

Lancaster University (UK)
University/education

Bailrigg
Lancaster
LA1 4YB
England
United Kingdom

Website http://www.physics.lancs.ac.uk/
ROR logo "ROR" https://ror.org/04f2nsd36

Funders

Funder type

Government

National Institute for Health Research (NIHR); Grant Codes: RP-PG-0606-1086
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 21/11/2012 Yes No
Results article results 01/01/2015 Yes No

Editorial Notes

26/09/2018: Publication reference added.