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

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

Strategies and challenges in the management of adolescent depression

“…These include the Adolescent Depression and Psychotherapy Trial (ADAPT) [9] and the Treatment of Resistant Depression in Adolescence (TORDIA) [7] studies, and warrant mention not only for their rigour and relevance, but also because follow-up studies addressing predictors of treatment response and other issues appear in the recent literature. Further such trials are also in progress [11]. The published RCTs have tended to indicate that by follow-up several months post-treatment SSRI is as effective as combined pharmacotherapy þ psychological therapy in severe and persistent cases of adolescent depression: refer to Walkup [12 && ] for a succinct and practical review of these studies.…”

Mood disorders in childhood and adolescence

“…5,24 On the path to define the best treatment option for depression, the Improving the Mood with Psychoanalytic and Cognitive Therapies (IMPACT) trial is an ongoing study that is planned to recruit 540 individuals to compare effectiveness and define superiority in reducing relapse among three approaches, combined with the use of fluoxetine as needed: CBT, short term psychoanalytic therapy, and specialist clinical care. 25 Children and adolescents appear to show a response pattern different from that observed in adults with respect to antidepressants -both in terms of efficacy and adverse effects (Table 1). Nonetheless, except for the use of lower initial doses to avoid side effects, the use of antidepressants in children and adolescents generally follows the same doses used in adults.…”

Therapy Expectations of Adolescents with Depression Entering Psychodynamic Psychotherapy: A Qualitative Study

“…Midgley and colleagues (Midgley, Ansaldo, & Target, 2014) conducted a first qualitative study on youth expectations of therapy. The study was part of a randomised-controlled trial to test the effectiveness of interventions for youth depression (Improving Mood with Psychoanalytic and Cognitive Therapies, IMPACT;Goodyer et al, 2011). They interviewed 77 participants (55 females) aged 11-17 years using a semi-structured interview schedule, the (Midgley et al, 2011).…”