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Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo.

ABSTRACT: Strategies to improve the course of recurrent major depressive disorder have great public health relevance. To reduce the risk of relapse/recurrence after acute phase cognitive therapy (CT), a continuation phase model of therapy may improve outcomes.To test the efficacy of continuation phase CT (C-CT) and fluoxetine for relapse prevention in a pill placebo (PBO)-controlled randomized trial and compare the durability of prophylaxis after discontinuation of treatments.A sequential, 3-stage design with an acute phase (all patients received 12 weeks of CT); 8-month experimental phase (responders at higher risk were randomized to C-CT, fluoxetine, or PBO); and 24 months of longitudinal, posttreatment follow-up.Two university-based specialty clinics.A total of 523 adults with recurrent major depressive disorder began acute phase CT, of which 241 higher-risk responders were randomized and 181 subsequently entered the follow-up.Cognitive therapy responders at higher risk for relapse were randomized to receive 8 months of C-CT (n?=?86), fluoxetine (n?=?86), or PBO (n?=?69).Survival analyses of relapse/recurrence rates, as determined by blinded evaluators using DSM-IV criteria and the Longitudinal Interval Follow-up Evaluation. RESULTS As predicted, the C-CT or fluoxetine groups were significantly less likely to relapse than the PBO group across 8 months. Relapse/recurrence rates for C-CT and fluoxetine were nearly identical during the 8 months of treatment, although C-CT patients were more likely to accept randomization, stayed in treatment longer, and attended more sessions than those in the fluoxetine and PBO groups. Contrary to prediction, relapse/recurrence rates following the discontinuation of C-CT and fluoxetine did not differ.Relapse risk was reduced by both C-CT and fluoxetine in an enriched randomization sampling only CT responders. The preventive effects of C-CT were not significantly more durable than those of fluoxetine after treatment was stopped, suggesting that some higher-risk patients may require alternate longer-term interventions.clinicaltrials.gov Identifiers: NCT00118404, NCT00183664, and NCT00218764.

SUBMITTER: Jarrett RB

PROVIDER: S-EPMC4204630 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo.

Jarrett Robin B RB Minhajuddin Abu A Gershenfeld Howard H Friedman Edward S ES Thase Michael E ME

JAMA psychiatry 20131101 11

<h4>Importance</h4>Strategies to improve the course of recurrent major depressive disorder have great public health relevance. To reduce the risk of relapse/recurrence after acute phase cognitive therapy (CT), a continuation phase model of therapy may improve outcomes.<h4>Objectives</h4>To test the efficacy of continuation phase CT (C-CT) and fluoxetine for relapse prevention in a pill placebo (PBO)-controlled randomized trial and compare the durability of prophylaxis after discontinuation of tr ...[more]

PMID: 24005123

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Project description:OBJECTIVES:Cognitive behavioural therapy (CBT) can improve symptoms of anxiety and depression, but also reduces the risk of future relapse after therapy completion. However, current CBT relapse prevention methods are resource-intensive and can be limited in clinical practice. This paper investigates a personalized means of reducing relapse using smart-messaging in two settings: research and routine care. DESIGN:Study 1 presents a cohort study comparing a cohort of smart-messaging users versus non-users. Study 2 presents time series follow-up data from a case series of smart-messaging users from clinical practice. METHODS:Fifteen of 56 CBT completers who participated in a trial for the treatment of health anxiety wrote advice they would want if in future they were doing well, experiencing early warning signs of relapse, or experiencing full relapse. Following CBT, participants received weekly text-message requests to rate their well-being. Dependent upon their response, participants received tailored advice they had written, appropriate to the well-being level reported after recovery from health anxiety. Smart-messaging was also trialled in a routine practice sample of 14 CBT completers with anxiety and depression. RESULTS:Across a 12-month follow-up, participants receiving smart-messaging showed greater health improvements than those who did not. Well-being scores showed stability between CBT completion and 6-month follow-up among routine care patients. CONCLUSIONS:These findings suggest that a low-intensity, personalized relapse prevention method can have a clinical benefit following CBT for common mental health problems. PRACTITIONER POINTS:Post-treatment outcomes may be improved using personalized smart-messaging to prevent relapse following cognitive behavioural therapy (CBT) for health anxiety. In clinical practice, post-treatment smart-messaging can be well-used by patients and may help maintain stable well-being in the 6 months after CBT ends. This evidence supports the clinical utility of a brief tailored digital intervention, which can be integrated within routine clinical practice with minimal therapist input. Overall, longer-term post-CBT outcomes may be improved by integrating a smart-messaging intervention at the end of therapy.

Project description:BackgroundSeasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD.Methods/designThis is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes.DiscussionThe chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT's outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome.Trial registrationClinicaltrials.gov identifier NCT01714050.

Project description:UnlabelledBackgroundDepression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT?Methods/designTwo parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio.DiscussionTaking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT.Trial registrationClinicalTrials.gov: NCT00928980.

Dataset Information

Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo.

Publications

Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders: a randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo.

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