Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants

Abstract

BackgroundMaintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However, in clinical practice most patients (up to 70-80%) are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT). However, it is unclear whether brief CT while tapering antidepressants (AD) is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial.Methods/designTherefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes). This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276) will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective) and number, duration and severity of relapses/recurrences.DiscussionThis will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment compared to antidepressant treatment alone and the combination of both. In addition, we explore explicit and implicit mediators of CT.Trial registrationNetherlands Trial Register (NTR): NTR1907

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).…”

“…Recent randomized controlled trials indicate that internet based CT started after (partial) remission is effective preventing a rise in depressive symptomatology and in preventing relapse and recurrence (Holländare et al, 2011(Holländare et al, , 2013Kok et al, 2015). In addition, using technical devices to support ongoing patient monitoring, such as text messages and apps for smart phones might facilitate long term monitoring on relapse (Bockting, Elgersma, et al, 2011;Bockting, Kok, et al, 2011;Kordy et al, 2013).…”

“…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).…”

“…However, as few studies have directly tested mediation of preventive psychological interventions in relapse and recurrence prevention, further research is required to understand the working mechanism of current effective relapse and recurrence-prevention strategies, such as preventive C-CT (Jarrett et al, 1998); CBT and MBCT. As these processes are better understood, treatments can improve by targeting key mechanisms involved in depressive relapse/recurrence (Beshai et al, 2011;Bockting, Elgersma, et al, 2011;Bockting, Kok, et al, 2011).…”

Cognitive reactivity, self-depressed associations, and the recurrence of depression

“…The studies were approved by the Medical Ethical Committee of the Dutch mental health care institutions (METIGG), and registered at the Dutch Trial Register (NTR 1907 andNTR 2503). The design and protocol of both RCTs are described elsewhere (Bockting et al, 2011a(Bockting et al, , 2011b. Participants in both RCTs had been recruited via media and via referrals of general practitioners, pharmacists, company doctors, and mental health care institutions (Bockting et al, 2011a(Bockting et al, , 2011b.…”