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      The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial

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          Abstract

          Objective To evaluate whether a new computerised cognitive behavioural therapy intervention (SPARX, Smart, Positive, Active, Realistic, X-factor thoughts) could reduce depressive symptoms in help seeking adolescents as much or more than treatment as usual.

          Design Multicentre randomised controlled non-inferiority trial.

          Setting 24 primary healthcare sites in New Zealand (youth clinics, general practices, and school based counselling services).

          Participants 187 adolescents aged 12-19, seeking help for depressive symptoms, with no major risk of self harm and deemed in need of treatment by their primary healthcare clinicians: 94 were allocated to SPARX and 93 to treatment as usual.

          Interventions Computerised cognitive behavioural therapy (SPARX) comprising seven modules delivered over a period of between four and seven weeks, versus treatment as usual comprising primarily face to face counselling delivered by trained counsellors and clinical psychologists.

          Outcomes The primary outcome was the change in score on the children’s depression rating scale-revised. Secondary outcomes included response and remission on the children’s depression rating scale-revised, change scores on the Reynolds adolescent depression scale-second edition, the mood and feelings questionnaire, the Kazdin hopelessness scale for children, the Spence children’s anxiety scale, the paediatric quality of life enjoyment and satisfaction questionnaire, and overall satisfaction with treatment ratings.

          Results 94 participants were allocated to SPARX (mean age 15.6 years, 62.8% female) and 93 to treatment as usual (mean age 15.6 years, 68.8% female). 170 adolescents (91%, SPARX n=85, treatment as usual n=85) were assessed after intervention and 168 (90%, SPARX n=83, treatment as usual n=85) were assessed at the three month follow-up point. Per protocol analyses (n=143) showed that SPARX was not inferior to treatment as usual. Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children’s depression rating scale-revised (between group difference 2.73, 95% confidence interval −0.31 to 5.77; P=0.079). Remission rates were significantly higher in the SPARX arm (n=31, 43.7%) than in the treatment as usual arm (n=19, 26.4%) (difference 17.3%, 95% confidence interval 1.6% to 31.8%; P=0.030) and response rates did not differ significantly between the SPARX arm (66.2%, n=47) and treatment as usual arm (58.3%, n=42) (difference 7.9%, −7.9% to 24%; P=0.332). All secondary measures supported non-inferiority. Intention to treat analyses confirmed these findings. Improvements were maintained at follow-up. The frequency of adverse events classified as “possibly” or “probably” related to the intervention did not differ between groups (SPARX n=11; treatment as usual n=11).

          Conclusions SPARX is a potential alternative to usual care for adolescents presenting with depressive symptoms in primary care settings and could be used to address some of the unmet demand for treatment.

          Trial registration Australian New Zealand Clinical Trials ACTRN12609000249257.

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          Most cited references16

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          Major depressive disorder in older adolescentsPrevalence, risk factors, and clinical implications

          In this article we summarize our current understanding of depression in older (14-18 years old) adolescents based on our program of research (the Oregon Adolescent Depression Project). Specifically, we address the following factors regarding adolescent depression: (a) phenomenology (e.g., occurrence of specific symptoms, gender and age effects, community versus clinic samples); (b) epidemiology (e.g., prevalence, incidence, duration, onset age); (c) comorbidity with other mental and physical disorders; (d) psychosocial characteristics associated with being, becoming, and having been depressed; (e) recommended methods of assessment and screening; and (f) the efficacy of a treatment intervention developed for adolescent depression, the Adolescent Coping With Depression course. We conclude by providing a set of summary statements and recommendations for clinicians.
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            The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioral program with adolescents.

            The aim in the current study was to investigate the effectiveness of an online, self-directed cognitive-behavioral therapy program (MoodGYM) in preventing and reducing the symptoms of anxiety and depression in an adolescent school-based population. A cluster randomized controlled trial was conducted with 30 schools (N = 1,477) from across Australia, with each school randomly allocated to the intervention or wait-list control condition. At postintervention and 6-month follow-up, participants in the intervention condition had significantly lower levels of anxiety than did participants in the wait-list control condition (Cohen's d = 0.15-0.25). The effects of the MoodGYM program on depressive symptoms were less strong, with only male participants in the intervention condition exhibiting significant reductions in depressive symptoms at postintervention and 6-month follow-up (Cohen's d = 0.27-0.43). Although small to moderate, the effects obtained in the current study provide support for the utility of universal prevention programs in schools. The effectiveness of booster sessions should be explored in future research.
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              A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.

              Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale--Revised, a measure of the severity depressive symptoms. Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated "much" or "very much" improved on the Clinical Global Impressions scale at study exit (chi 2 = 5.1, df = 1, P = .02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale--Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n = 48) and those aged 13 years and older (n = 48). However, complete symptom remission (Children's Depression Rating Scale--Revised < or = 28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.

                Author and article information

                Contributors
                Role: associate professor
                Role: research fellow
                Role: lecturer
                Role: associate professor of biostatistics
                Role: research fellow
                Role: research fellow
                Journal
                BMJ
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2012
                2012
                19 April 2012
                : 344
                : e2598
                Affiliations
                [1 ]Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand
                [2 ]School of Counselling, Human Services and Social Work, Faculty of Education, University of Auckland
                [3 ]Department of Psychological Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, New Zealand
                Author notes
                Correspondence to S N Merry s.merry@ 123456auckland.ac.nz
                Article
                mers001058
                10.1136/bmj.e2598
                3330131
                22517917
                48e08fd5-1fb1-4354-95ed-37e205894d8e
                © Merry et al 2012

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 9 March 2012
                Categories
                Research
                General Practice / Family Medicine
                Adolescent Health
                Child and Adolescent Psychiatry (Paedatrics)
                Child Health
                Child and Adolescent Psychiatry
                Mood Disorders (Including Depression)
                Sociology

                Medicine
                Medicine

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