Condition category
Mental and Behavioural Disorders
Date applied
08/04/2011
Date assigned
08/04/2011
Last edited
03/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Heather Law

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8950

Study information

Scientific title

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 measures

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

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

http://www.physics.lancs.ac.uk/

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

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23171304

Publication citations

  1. 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.

Additional files

Editorial Notes