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A pilot trial for Think Effectively About Mood Swings (TEAMS)

A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy (CBT) for People with Bipolar Disorders and Current Symptoms: Think Effectively About Mood Swings (TEAMS)

Specialty
MentalHealth
Portfolio Eligibility
Automatically eligible
ISRCTN 83928726
EudraCT
MREC N° 11/LO/1326
UKCRN ID 11119
WHO ID
Research Summary
Adults with bipolar disorders randomized to TEAMS plus TAU or TAU. TEAMS involves 16 treatment sessions over 6 months. Outcomes at 3, 6 and 12 months with blind interviewers. The main hypothesis is that TEAMS will reduce depression in comparison to treatment as usual at 6 and 12 months post-randomisation The secondary hypotheses are that TEAMS will: 1) reduce the severity of hypomanic symptoms and anxiety 2) reduce thinking styles responsible for maintaining symptoms which will be targeted by the therapy, 3) improve social functioning and promote recovery compared to treatment as usual at post-treatment and follow-up. These effects are predicted to be strongest in those patients whose therapy is assessed as reflecting the closest adherence to the TEAMS approach and who show the greatest shifts in a measure of the thinking style targeted by TEAMS. The trial will also explore the relative costs and outcomes of the TEAMS intervention in comparison to treatment as usual and whether the incremental cost per quality adjusted life year (QALY) gained by the intervention is acceptable to UK policy makers (e.g. NICE) and commissioners. The second objective is to obtain in depth feedback from service users and front line clinical staff, through the use of qualitative methodology (thematic analysis) about their preferences regarding psychological treatment prior to the trial, feedback on the features of the treatment they found helpful and unhelpful, and their constructive suggestions for future interventions.
Study Type Interventional
Design Type Treatment
Disease(s) Bipolar affective disorder
Phase Pilot/Feasibility
Current Status Closed - in follow-up
Closure Date 1/13/2014
Global Sample Size 82
Global Recruitment to Date
100%
Geographical Scope UK Multi-Centre
Lead Country England
Study Website
Main Inclusion Criteria
1) Meet DSM-IV criteria for bipolar I or II disorder, or bipolar disorder nototherwise specified, characterised by a past major depressive episode and DSM-IV hypomania of two days or more (Akiskal et al., 2006). 2) Complete baseline assessment sessions in an outpatient setting 3) A baseline score of at least 15 on the Beck Depression Inventory that is maintained over two consecutive weeks prior to the study (to ensure presence of significant current distress as targeted in the trial) 4) Aged 16 and above
Main Exclusion Criteria
1) A diagnosis of a non-affective psychotic disorder according to DSM-IV 2) Current mania or mixed episode according to DSM-IV 3) A primary substance use disorder according to DSM-IV 4) Moderate to severe learning disability 5) Organic impairment that accounts for mental health problem 6) Non-English speaking (owing to the standardised assessment measures)
Chief Investigator(s)
Dr Sara Tai
Further details, please contact
Dr Warren Mansell

University of Manchester
School of Psychological Sciences
Zochonis Building
Oxford Road
Manchester
Greater Manchester
M13 9PL
UNITED KINGDOM

Tel: 01612758589
warren.mansell@manchester.ac.uk
Dr Sara Tai

University of Manchester
School of Psychological Sciences
Zochonis Building
Oxford Road
Manchester
Greater Manchester
M13 9PL
UNITED KINGDOM

Tel: 0161 275 2595
sara.tai@manchester.ac.uk
Funder(s) NIHR Research for Patient Benefit (RfPB)
Sponsor(s) University of Manchester




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