title: Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated.
  
  
  METHODS
  Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry.
  
  
  CONCLUSIONS
  The objective of this clinical trial is to determine whether there are specific effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN83033550.
authors.affiliation: Department of Psychiatry, University of Cambridge and the Cambridge and Peterborough Foundation Trust, Douglas House, 18b Trumpington Road Cambridge, UK. ig104@cam.ac.uk.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Goodyer
authors.forename: Sonya
authors.initials: S
authors.lastname: Tsancheva
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
authors.forename: Bernadka
authors.initials: B
authors.lastname: Dubicka
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hill
authors.forename: Raphael
authors.initials: R
authors.lastname: Kelvin
authors.forename: Shirley
authors.initials: S
authors.lastname: Reynolds
authors.forename: Christopher
authors.initials: C
authors.lastname: Roberts
authors.forename: Robert
authors.initials: R
authors.lastname: Senior
authors.forename: John
authors.initials: J
authors.lastname: Suckling
authors.forename: Paul
authors.initials: P
authors.lastname: Wilkinson
authors.forename: Mary
authors.initials: M
authors.lastname: Target
authors.forename: Peter
authors.initials: P
authors.lastname: Fonagy
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000339:Affect; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D017048:Health Care Costs; D006801:Humans; D011569:Psychiatric Status Rating Scales; D011575:Psychoanalytic Therapy / Q000191:economics; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom