title: A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed 'Think Effectively About Mood Swings' (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial.
  
  
  METHODS
  A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach.
  
  
  CONCLUSIONS
  The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual.
  
  
  BACKGROUND
  This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.
authors.forename: Warren
authors.initials: W
authors.lastname: Mansell
authors.forename: Sara
authors.initials: S
authors.lastname: Tai
authors.forename: Alexandra
authors.initials: A
authors.lastname: Clark
authors.forename: Savas
authors.initials: S
authors.lastname: Akgonul
authors.forename: Graham
authors.initials: G
authors.lastname: Dunn
authors.forename: Linda
authors.initials: L
authors.lastname: Davies
authors.forename: Heather
authors.initials: H
authors.lastname: Law
authors.affiliation: The Psychosis Research Unit, GMW Mental Health NHS Foundation Trust, Harrop House, Bury New Road, Prestwich, Manchester M25 3BL, UK. richard.morriss@nottingham.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Morriss
authors.forename: Neil
authors.initials: N
authors.lastname: Tinning
authors.forename: Anthony P
authors.initials: AP
authors.lastname: Morrison
mesh_terms: D000339:Affect; D001714:Bipolar Disorder / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D004739:England; D017048:Health Care Costs; D006801:Humans; D007407:Interviews as Topic; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012720:Severity of Illness Index; D013850:Thinking; D013997:Time Factors; D016896:Treatment Outcome