Abstract
BackgroundUp 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/DesignImproving 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.DiscussionThe 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.Trial RegistrationCurrent Controlled Trials ISRCTN83033550
Highlights
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
Later episodes of recurrent disorder are associated with fewer external stressors suggesting that a history of depressive episodes may itself increase the risk of further illness even in the presence of reduced external adversities [4,5]
We propose to make two: a) the two individual specialist treatments Cognitive Behaviour Therapy (CBT) and Short Term Psychoanalytic Psychotherapy (STPP) will be compared; and b) the individual specialist treatments combined will be compared with Specialist Clinical Care (SCC)
Summary
The treatment efficacy and effectiveness for unipolar major depressions in post pubertal adolescents has established that combination psychological and SSRI treatment is the therapy of choice for establishing remission in the short term. List of abbreviations used throughout the paper ADAPT: Adolescent Depression, Antidepressants and Psychotherapy Trial: The ADAPT Study; AIM: Adolescent Integrative Measure; APQ:Alabama Parenting Questionnaire; CAMHS: Child and Adolescent Mental Health Services; CASUS: Child and Adolescent Service Use Schedule; CBT: Cognitive Behavioural Therapy; CGS: Clinical Global Impressions Scale; C-SSRS: Columbia Suicide Severity Rating Scale; DEQ: Depressive Experiences Questionnaire; DES-IV: Differential Emotion Scale; DSC: Depressive States Checklist; DSM-IV: Diagnostic and statistical manual of mental health disorders (4thed); EQ-5D: Euroquol; FAD: The McMaster Family Assessment Device; HCAM: Hampstead Child and Adaptation Measure; HoNOSCA: The Health of the National Outcome Scale for Children and Adolescents; ICER: Incremental costeffectiveness ratios; ID: Identification; IMPACT: Improving mood with Psychoanalytic and Cognitive Therapies; IPT: Interpersonal Psychotherapy; KSADS-PL: Schedule for Affective Disorders and Schizophrenia for School Aged Children (6-18 years) present and lifetime; LEQ: Life Events Questionnaire; LOI: Leyton Obsessional Inventory; MD: Major Depression; MDD: Major Depressive Disorder; MFQ: Moods and Feelings Questionnaire; MRI: Magnetic Resonance Imaging; NEO-FFI: NEO-Five Factor Inventory; NHS: National Health Service; NICE: National Institute for Clinical excellence; OA: Outcome assessor; RCMAS: Revised Manifest Anxiety Scale; RCT: Randomised Controlled Trial; RSES: Rosenberg Self-esteem Scale; RTSHIA: The Risk Taking and Self-Harming Inventory for Adolescents; SCC: Specialist Clinical Care; SCL:: Symptom Checklist; SD: Standard Deviation; SSRI: Selective Serotonin Reuptake Inhibitors; STPP: Short Term Psychoanalytic Psychotherapy; UK: The United Kingdom; WAI-S: Working Alliance Inventory - Short form; YPQ: Young Persons Questionnaire; ZAN:BPD: Zanerini Rating Scale for Borderline Personality Disorder
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