Abstract/Summary

Summary Background Psychological treatments for adolescents with unipolar major depressive disorder (MDD) are associated with diagnostic remission within 28 weeks in 65%-70% of cases. It is not known however whether a particular psychological treatment that is effective for the acute episode results in a sustained recovery, thereby reducing relapse risk, in the year following end of treatment. Methods In this observer blind, parallel group, pragmatic superiority randomised controlled trial (IMPACT), we recruited adolescent patients (11-17 years) with a DSM IV major depressive episode from 15 NHS CAMHS clinics in England. Participants were randomly assigned to one of two established treatments, cognitive behaviour therapy (CBT) or short-term psychoanalytic therapy (STPP), which were compared to a reference brief psychological intervention (BPI). Treatment allocation was carried out by the trial coordinator using stochastic minimization controlling for age, gender and self-reported depression sum score. The patients were followed up and reassessed at five planned time points from randomisation. The primary outcome was self-reported depression symptoms obtained at the notional 36,52 and 86 week post randomisation assessment. The primary analysis was based on intention to treat. The trial is registered with Current Controlled Trials, ISRCTN83033550. Findings Between June 29th 2010 and January 17th 2013 we assessed 557 patients of whom 87 were excluded as not meeting eligibility criteria, 5 withdrew after treatment allocation and 465 were included. These were randomly assigned to BPI (n=155), CBT (n=154) and STPP (n=156) respectively. Treatment fidelity and differentiation were established between the three interventions. The median number of treatment sessions was significantly different (BPI = 6; CBT = 9, STPP = 11, Kruskal-Wallis rank test p<0•001) but there was no difference in the average duration of treatment in weeks between the groups (BPI 27•5 (sd 21•5), CBT 24•9 (sd17•7), STPP 27•9 (sd16•8), Kruskal Wallis p= 0•238). Of the 465 who entered the study 392 (84%) had available data for primary analysis by end of follow up. There were no significant differences between STPP and CBT in reducing depressive symptoms by end of study (treatment effect by final follow up = 0•578, 95% CI, -2•948 to 4.104, p= 0•748) nor were there any superiority effects for these two treatments (CBT+STPP) compared to BPI (treatment effect by final follow up = -1•898, 95% CI, -4•922- 1•126, p= 0•219). By the notional 86 week final assessment there was no significant difference in the mean depressive score between treatment groups. There was an average 49-52% reduction in symptoms 12 months after the end of therapy. At end of study, 221 (77%) of the 286 consenting to interview, were in diagnostic remission. Physical adverse effects (breathing problems, sleep disturbances, drowsiness/tiredness, nausea, sweating, restless/overactive) were no different between the groups. Prescribing of an SSRI during treatment or in the post treatment follow-up period did not differ between the treatment arms and so did not mediate the outcome. The proportion of patients who reported suicide attempts or non suicidal self injury by end of study was not increased over the baseline assessments nor associated with SSRI prescribing over the study. There were no differences in total costs or quality of life scores between treatment groups. Interpretation All three psychological therapies are associated with maintaining reduced depressive symptoms up to a year after the end of treatment. STPP is as effective as CBT and together with BPI offers additional patient choice for psychological therapy, alongside CBT, for moderately to severely depressed adolescents attending routine specialist CAMHS.