The effectiveness of SPARX
Exclusion criteria
A clinician assessed that the depression was too severe to make a self help resource a viable option A clinician assessed the adolescent to be at high risk of self harm or suicide Scored 7 on item 12 (morbid ideation) or 5 or higher on item 13 (suicidal ideation) on the children's depression rating scale-revised Raw score was less than 30 on children's depression rating scale-revised Intellectual disability or physical limitations precluded the use of the computer program Had another major mental health disorder where the primary focus was not depression Had had (in past three months) or was having treatment with cognitive behavioural therapy, interpersonal therapy, or antidepressants
The control group was allocated to treatment as usual. At youth clinics and school based counselling services, treatment as usual was anticipated to be face to face therapy provided by trained counsellors or psychologists.
At general practices, treatment as usual was likely to comprise assessment and treatment by general practitioners with psychological treatment where indicated and available. We collected data on the number and duration of sessions and type of therapy.
Description of content and core skills covered in each module (level) of SPARX
Level 1—cave province: finding hope Psychoeducation about depression and an introduction to the cognitive behavioural therapy model Introducing GNATs (Gloomy Negative Automatic Thoughts) Introducing "hope" (people recover from depression) Relaxation: controlled breathing Level 2—ice province: being active Activity scheduling and behavioural activation Relaxation: progressive muscle relaxation Basic communication and interpersonal skills Level 3—volcano province: dealing with emotions Dealing with strong emotions: anger and hurt feelings Interpersonal skills: assertiveness, listening, and negotiation Level 4—mountain province: overcoming problems Problem solving using STEPS: Say the problem, Think of solutions, Examine the pros and cons, Pick one and try it, See what happens Cognitive restructuring-identifying SPARX: Smart, Positive, Active, Realistic, X-factor thoughts Level 5—swamp province: recognising unhelpful thoughts Cognitive restructuring—recognising different types of GNATs Level 6—bridgeland province: challenging unhelpful thoughts Cognitive restructuring—learning to challenge or "swap" negative thoughts for helpful ones Interpersonal skills continued: negotiation skills Level 7—canyon province: bringing it altogether Recap of all skills Mindfulness: tolerating distress Relapse prevention: knowing when to ask for help
Randomisation and sequence generation We randomly allocated participants to SPARX or treatment as usual in a 1:1 ratio, using a computer generated randomisation sequence prepared before any participants were randomised. Allocation was stratified by study site and arranged in permuted blocks of 4.
Potential participants were informed about the study by their clinicians. A research assistant not involved in the participants' clinical care confirmed eligibility. To ensure allocation concealment, once eligibility had been confirmed, the participant was given an opaque sealed envelope containing the randomised allocation. The young person took this to a local investigator who opened the envelope, informed the young person of the allocation, and organised access to SPARX or treatment as usual. The assessment package and randomisation envelopes were stored off-site and were available only to the research assistants.
Inclusion criteria
Presented for treatment with symptoms indicative of mild to moderate depressive disorder Aged 12 to 19 years on the date of consent Provided written consent or, if under age 16, written parental consent Attended a clinical service or school based counselling service that was a study site Achieved a minimum of one year of schooling in English Had access to a computer to use SPARX
Secondary outcome measures For our secondary outcome measures we chose the following self rated scales on the basis of psychometric properties and ease of use:
The Reynolds adolescent depression scale-second edition23 is a 30 item self report measure developed to evaluate the severity of depressive symptoms in adolescents.20 Its reliability, validity, and normative data are well documented.20 Mean raw scores in the range 76-81 fall into the mild clinical depression range.23 The scale has been validated for use in New Zealand adolescents.24 In our study population the Cronbach's α coefficient was 0.91. The mood and feelings questionnaire25 is a brief (33 items) self administered measure designed to detect clinical depression in children and adolescents. In our study population the Cronbach's α coefficient was 0.91. The paediatric quality of life enjoyment and satisfaction questionnaire26 is a quality of life self report measure designed specifically for use in children and adolescents. It covers 15 areas and ratings are made on a five point scale from "very poor" to "very good." In our study population the Cronbach's α coefficient was 0.89. The Spence children's anxiety scale27 is a well validated 46 item self report scale measuring child anxiety. In addition to a total score, it has six subscales, which measure specific types of anxiety. In our study population the Cronbach's α coefficient for the total score was 0.86. The Kazdin hopelessness scale for children28 is a 17 item modification of the Beck hopelessness scale.28 It is self administered and has been widely used in studies of suicidality in youth. In our study population the Cronbach's α coefficient was 0.84.
Sample size Using data from a pilot study by our group we calculated that about 300 participants per arm (600 total) would be required to power this non-inferiority study and allow some latitude for exploration of subgroup (sex, age, ethnicity, setting, and baseline depression) effects on efficacy.
The pilot study included 34 participants with similar eligibility criteria, identical primary outcome measures, and the same timing of the primary outcome as participants in this trial. The standard deviation of the change on the children's depression rating scale-revised was 28. Using two tailed 95% confidence intervals, non-inferiority (not worse than 5.5 units inferior change on the children's depression rating scale-revised) would be identified with 80% power if about 600 participants were recruited.
Introduction Up to a quarter of young people will have experienced a depressive disorder by the age of 19, which is a major cause of disability. Effective therapies exist, with cognitive behavioural therapy recommended as the preferred treatment for mild to moderate depressive disorder. However, fewer than
a fifth of young people with depressive disorder receive treatment, partly because of shortages in the workforce and partly because young people may be reluctant to seek traditional help. Computerised therapy offers a potential way forward and may appeal to today's "digital natives."9 The cost of computerised therapy is likely to be substantially lower than traditional therapy and can increase access to treatment.
If computerised cognitive behavioural therapy can reduce symptoms and is at least as effective as treatment as usual it would be worth disseminating, because of the
associated lower cost and the potential for reaching young people who currently do not access help.
The children's depression rating scale-revised contains several categories—for example, "depressive disorder might be confirmed in a comprehensive diagnostic evaluation" and "depressive disorder is likely to be confirmed." The range of raw scores between these categories is 12-14. We argued that a difference of less than half a category was not likely to be clinically significant. When the recruitment rate was well below our anticipated targets, we
extended the recruitment period and decided that adequately powered subgroup analyses would not be feasible. We recalculated the sample size for overall efficacy based on our accumulated data. This revised power calculation was undertaken as an interim summary of the overall variance of the change, not to test any of the study hypotheses, and therefore did not unblind us to treatment allocation. We estimated the variation in change on the children's depression rating scale-revised, based on the 55 participants (26 treatment as usual, 29 SPARX) who had baseline and post-intervention scores on that scale. The standard deviation of the change in scores based on this interim summary was 10.2, considerably less than the original estimate. Using this estimate and the same variables above, the power calculation indicated a revised total sample size of 190 participants. This calculation allows for about 30% attrition from the intention to treat population; this 30% includes those potentially lost to follow-up or not adhering to the treatment protocol.
The clinicians also rated change on the improvement domain of the clinical global impression scale. It is a widely used single item scale requiring the assessor to rate
how much the participant has changed relative to a baseline state (on a seven point scale from "very much improved" to "very much worse"). Participants completed a short questionnaire developed for the purpose of this study to assess satisfaction with and enjoyment of the allocated intervention.
Our secondary hypotheses were that SPARX would lead to
improvements as much or more than treatment as usual on self rated measures of depression, anxiety and hopelessness, and quality of life and on a clinician measure of overall improvement; and the change seen at the end of treatment would be maintained at follow-up (three months after completing the intervention).
Computerised therapy offers a potential way forward and may appeal to today's "digital natives." The cost of computerised therapy is
likely to be substantially lower than traditional therapy and can increase access to treatment.
Outcome measures Primary outcome measure The children's depression rating scale-revised18 is an
observer rated scale developed specifically for children but often used for adolescents. It has sound psychometric properties, is widely used in clinical research, and has been used to assess change in severity of depression in studies of treatment. The scale can be used as a screening and diagnostic tool and as a measure of severity of depression. It covers 17 symptom areas, which are rated on a seven point or five point scale, with the higher rating suggesting more severe difficulties. In our study population the Cronbach's α coefficient was 0.84. We trained and supervised research assistants, who were blinded to the intervention, to carry out the ratings.
Trial design We carried out a randomised controlled non-inferiority trial to compare SPARX with treatment as usual. Outcome data were collected at baseline, post-intervention (about two months after the start of the intervention), and at follow-up three months later (five months after the start of the intervention). Safety data were collected at all time points, with an extra, brief check one month after the start of intervention. Satisfaction with the intervention was rated
post-intervention and at the three month follow-up. The only change to study methods after the trial started was a change in sample size.
Computerised cognitive behavioural therapy is effective for depressed adults, although adherence to treatment can be problematic. Recent reviews identified only eight studies on four computerised interventions for depression in children and adolescents. None was a
randomised controlled trial of the effectiveness of the intervention as a treatment for depression, but both reviews concluded that this approach is promising. We have carried out two small studies of computerised interventions for depressive symptoms; one showed a significant effect compared with placebo and the other was significantly more effective than a waitlist control. A small open trial carried out by another group showed encouraging results. The other papers identified were on depression prevention studies.
The scale can be used as a
screening and diagnostic tool and as a measure of severity of depression. It covers 17 symptom areas, which are rated on a seven point or five point scale, with the higher rating suggesting more severe difficulties. In our study population the Cronbach's α coefficient was 0.84. We trained and supervised research assistants, who were blinded to the intervention, to carry out the ratings.
At the beginning and end of each module, the user interacts in the first person with a "guide," who puts the game into context, provides education, gauges mood, and sets and monitors real-life challenges, equivalent to homework. Young people who are not improving are prompted to
seek help from their referring clinicians. SPARX is supplemented by a paper notebook with summaries of each module and spaces to add comments about the challenges completed
Interventions SPARX is an interactive fantasy game designed to deliver cognitive behavioural therapy for the treatment of clinically significant depression. It utilises both first person instruction and a three dimensional interactive game in which the young person chooses an avatar and undertakes a series of challenges to restore the balance in a fantasy world dominated by GNATs (Gloomy Negative Automatic Thoughts). The game consists of
seven modules (levels), completed sequentially. At the beginning and end of each module, the user interacts in the first person with a "guide," who puts the game into context, provides education, gauges mood, and sets and monitors real-life challenges, equivalent to homework. Young people who are not improving are prompted to seek help from their referring clinicians. SPARX is supplemented by a paper notebook with summaries of each module and spaces to add comments about the challenges completed
Participants Young people seeking help for symptoms of depression, who met the inclusion criteria, were recruited sequentially through youth clinics (clinics specialising in providing primary healthcare to adolescents and young adults), general practices, and school based counselling services (in New Zealand, school guidance counsellors are trained to provide counselling for mental health problems and are often the first point of contact for adolescents with difficulties) in seven provincial and urban locations in New Zealand. We have labelled both healthcare professionals and school guidance counsellors as "clinicians." We asked clinicians to use
the score of on the patient health questionnaire- (the depression scale of the patient health questionnaire), as a guide to ensure that young people had clinically significant depression. However, we were inclusive and, if young people reported that the depression was troubling enough to need intervention and clinicians agreed with this assessment, we accepted them.
Blinding It was not possible to blind the participants or treatment providers. However, trained research assistants, blinded to treatment allocation, carried out all assessments and administered the rating scales. Those analysing data were
unaware of the treatment allocation. Research assistants, staff at treatment centres, and the participants were briefed to not discuss which treatment participants were receiving.
We designed a computerised cognitive behavioural therapy intervention, SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), for adolescents seeking help for depression and tested its effectiveness compared with treatment as usual. We specifically aimed to design an intervention that would have
wide appeal to young people in New Zealand and elsewhere and that would be enjoyable, thus resulting in good adherence rates. If computerised cognitive behavioural therapy can reduce symptoms and is at least as effective as treatment as usual it would be worth disseminating, because of the associated lower cost and the potential for reaching young people who currently do not access help.
Methods Our primary hypothesis was that SPARX
would reduce depressive symptoms as much or more than treatment as usual as measured on the children's depression rating scale-revised18 immediately after treatment compared with baseline. Our secondary hypotheses were that SPARX would lead to improvements as much or more than treatment as usual on self rated measures of depression, anxiety and hopelessness, and quality of life and on a clinician measure of overall improvement; and the change seen at the end of treatment would be maintained at follow-up (three months after completing the intervention).