Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8950
Study information
Scientific title
An exploratory randomised controlled trial of a CBT-based recovery intervention for early bipolar disorder
Acronym
Study hypothesis
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
10/H1014/60
Study design
Randomised Interventiona; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
09/02/2011
Overall trial end date
30/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 72; UK Sample Size: 72
Participant 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.
Recruitment start date
09/02/2011
Recruitment end date
30/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
Manchester
M25 3BL
United Kingdom
Sponsor information
Organisation
Lancaster University (UK)
Sponsor details
Bailrigg
Lancaster
LA1 4YB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR); Grant Codes: RP-PG-0606-1086
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23171304
2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25213157
Publication citations
-
Protocol
Jones S, Mulligan LD, Law H, Dunn G, Welford M, Smith G, Morrison AP, A randomised controlled trial of recovery focused CBT for individuals with early bipolar disorder., BMC Psychiatry, 2012, 12, 204, doi: 10.1186/1471-244X-12-204.