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

ISRCTN	ISRCTN43062149
DOI	https://doi.org/10.1186/ISRCTN43062149
Protocol serial number	8950
Sponsor	Lancaster University (UK)
Funder	National Institute for Health Research (NIHR); Grant Codes: RP-PG-0606-1086

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

Primary study design	Interventional
Study design	Randomised Interventiona; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Time to bipolar relapse 2. Timepoint(s): assessed every 3 months from baseline
Key secondary outcome measure(s)	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
Completion date	30/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Psychology Department

Manchester
M25 3BL
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	01/01/2015		Yes	No
Protocol article	protocol	21/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/09/2018: Publication reference added.