Disrupting the rhythm of depression using Mobile Cognitive Therapy for recurrent depression: randomized controlled trial design and protocol

Abstract

BackgroundMajor depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The major contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Accordingly, efforts to reduce the disabling effects of this chronic condition should shift to preventing recurrence, especially in patients at high risk of recurrence. Given its high prevalence and the fact that interventions are necessary during the remitted phase, new approaches are needed to prevent relapse in depression.Methods/designThe best established effective and available psychological intervention is cognitive therapy. However, it is costly and not available for most patients. Therefore, we will compare the effectiveness and cost-effectiveness of self-management supported by online CT accompanied by SMS based tele-monitoring of depressive symptomatology, i.e. Mobile Cognitive Therapy (M-CT) versus treatment as us usual (TAU). Remitted patients (n = 268) with at least two previous depressive episodes will be recruited and randomized over (1) M-CT in addition to TAU versus (2) TAU alone, with follow-ups at 3, 12, and 24 months. Randomization will be stratified for number of previous episodes and type of treatment as usual. Primary outcome is time until relapse/recurrence over 24 months using DSM-IV-TR criteria as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). For the economic evaluation the balance between costs and health outcomes will be compared across strategies using a societal perspective.DiscussionInternet-based interventions might be helpful in empowering patients to become their own disease managers in this lifelong recurrent disorder. This is, as far as we are aware of, the first study that examines the (cost) effectiveness of an E-mental health program using SMS monitoring of symptoms with therapist support to prevent relapse in remitted recurrently depressed patients.Trial registrationNetherlands Trial Register (NTR): NTR2503

A lifetime approach to major depressive disorder: The contributions of psychological interventions in preventing relapse and recurrence

“…medication, behavioral therapy, exercise) on several outcomes, including positive mood (Goyal et al, 2014). Currently, larger scale trials are in progress to address the question whether a psychological intervention can be an alternative for continuation/maintenance ADMs (MOMENT study, Huijbers et al, 2012;PREVENT study, Kuyken et al, 2010; Break the rhythm of depression study, Bockting, Elgersma, et al, 2011;Bockting, Kok, et al, 2011).…”

“…Secondary prevention studies within randomized controlled trials, including tests of mediation, continue to be needed to establish if such treatments work through their hypothesized mechanism (e.g. Batink, Peeters, Geschwind, van Os, & Wichers, 2013;Bockting, Elgersma, et al, 2011;Bockting, Kok, et al, 2011;Kuyken et al, 2010;Williams et al, 2014).…”

The Three-Month Effect of Mobile Internet-Based Cognitive Therapy on the Course of Depressive Symptoms in Remitted Recurrently Depressed Patients: Results of a Randomized Controlled Trial

“…In order to be included in the randomized controlled trial [33], participants had to: (1) be between 18 and 65 years old and (2) be in remission/recovery from recurrent MDD for at least 2 months but not longer than 2 years according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) as assessed using the Structured Clinical Interview (SCID-I) based on the DSM-IV-TR [34] and a maximum score of 10 on the 17-item Hamilton Rating Scale for Depression (HRSD 17 ) [35]. Further, participants had to have Internet access.…”

No Sustainable Effects of an Internet-Based Relapse Prevention Program over 24 Months in Recurrent Depression: Primary Outcomes of a Randomized Controlled Trial

“…The aim of this single-blind 2-arm parallel randomized controlled trial (trial registration NTR2503; approved by METIGG, an independent medical ethics committee) was to examine whether adding M-CT to TAU is clinically superior to TAU alone over 24 months (primary outcome) in remitted recurrently depressed individuals. Details about the study design can be found elsewhere [7]. …”