BackgroundThis paper reports the results of a pilot randomized controlled trial comparing the delivery modality (mobile phone/tablet or fixed computer) of a cognitive behavioural therapy intervention for the treatment of depression. The aim was to establish whether a previously validated computerized program (The Sadness Program) remained efficacious when delivered via a mobile application.Method35 participants were recruited with Major Depression (80% female) and randomly allocated to access the program using a mobile app (on either a mobile phone or iPad) or a computer. Participants completed 6 lessons, weekly homework assignments, and received weekly email contact from a clinical psychologist or psychiatrist until completion of lesson 2. After lesson 2 email contact was only provided in response to participant request, or in response to a deterioration in psychological distress scores. The primary outcome measure was the Patient Health Questionnaire 9 (PHQ-9). Of the 35 participants recruited, 68.6% completed 6 lessons and 65.7% completed the 3-months follow up. Attrition was handled using mixed-model repeated-measures ANOVA.ResultsBoth the Mobile and Computer Groups were associated with statistically significantly benefits in the PHQ-9 at post-test. At 3 months follow up, the reduction seen for both groups remained significant.ConclusionsThese results provide evidence to indicate that delivering a CBT program using a mobile application, can result in clinically significant improvements in outcomes for patients with depression.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN 12611001257954
Together, the results show that iCBT is effective and adherence is high in research settings, but there is a problem of adherence when translated into the 'real world'. Future efforts need to be placed on developing improved adherence to iCBT in primary care settings.
Objective: Computerized cognitive-bias modification (CBM) protocols are rapidly evolving in experimental medicine yet might best be combined with Internet-based cognitive behavioral therapy (iCBT). No research to date has evaluated the combined approach in depression. The current randomized controlled trial aimed to evaluate both the independent effects of a CBM protocol targeting imagery and interpretation bias (CBM-I) and the combined effects of CBM-I followed by iCBT. Method: Patients diagnosed with a major depressive episode were randomized to an 11-week intervention (1 week/CBM-I + 10 weeks/iCBT; n = 38) that was delivered via the Internet with no face-to-face patient contact or to a wait-list control (WLC; n = 31). Results: Intent-to-treat marginal models using restricted maximum likelihood estimation demonstrated significant reductions in primary measures of depressive symptoms and distress corresponding to medium-large effect sizes (Cohen’s d = 0.62–2.40) following CBM-I and the combined (CBM-I + iCBT) intervention. Analyses demonstrated that the change in interpretation bias at least partially mediated the reduction in depression symptoms following CBM-I. Treatment superiority over the WLC was also evident on all outcome measures at both time points (Hedges gs = .59–.98). Significant reductions were also observed following the combined intervention on secondary measures associated with depression: disability, anxiety, and repetitive negative thinking (Cohen’s d = 1.51–2.23). Twenty-seven percent of patients evidenced clinically significant change following CBM-I, and this proportion increased to 65% following the combined intervention. Conclusions: The current study provides encouraging results of the integration of Internet-based technologies into an efficacious and acceptable form of treatment delivery.
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