Prevention of Recurrent Depression With Cognitive Behavioral Therapy

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Prevention of Recurrent Depression With Cognitive

Behavioral Therapy

Preliminary Findings

Giovanni A. Fava, MD; Chiara Rafanelli, MD; Silvana Grandi, MD; Sandra Conti, MD;Piera Belluardo, PhD

Arch Gen Psychiatry.1998;55:816-820.

ABSTRACT

Background Cognitive behavioral treatment (CBT) of residual symptoms aftersuccessful pharmacotherapy yielded a substantiallylower relapse rate than did clinical

management in patients

with primary major depressive disorders. The aim of this study

was to test the effectiveness of this approach in patients withrecurrent depression ( 3episodes of depression).

Methods Forty patients with recurrent major depressionwho had been successfullytreated with antidepressant drugswere randomly assigned to either CBT of residualsymptoms (supplementedby lifestyle modification and well-being therapy) or clinical

management. In both groups, during the 20-week experiment, antidepressantdrugadministration was tapered and discontinued. Residual symptomswere measured with amodified version of the Paykel ClinicalInterview for Depression. Two-year follow-up wasundertaken,during which no antidepressant drugs were used unless a relapseensued.

Results The CBT group had a significantly lower level

of residual symptoms afterdiscontinuation of drug therapy comparedwith the clinical management group. At 2-year follow-up, CBTalso resulted in a lower relapse rate (25%) than did clinical

management (80%). This difference attained statistical significanceby survival analysis.

Conclusions These results challenge the assumption thatlong-term drug treatment isthe only tool to prevent relapsein patients with recurrent depression. Althoughmaintenancepharmacotherapy seems to be necessary in some patients, CBToffers aviable alternative for other patients. Ameliorationof residual symptoms may reduce therisk of relapse in depressedpatients by affecting the progression of residual symptomstoprodromes of relapse.

INTRODUCTION

THE CHRONIC and recurrent nature of major depressivedisordersis getting increasing attention.1-2The development ofimprovedmaintenance treatment strategies for depressedpatients witha history of recurrent episodes has thus become acrucial clinicaland research issue.3-4Substantial evidencesupports the efficacyof long-term antidepressant medication use

in patients withrecurrent depression.3-4In particular, Frank etal5conducteda randomized 3-year maintenance trial in 128 patients with recurrent

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depression who had responded to combined short-term and continuationtreatment withimipramine hydrochloride and interpersonal psychotherapy.A 5-cell design was used todetermine whether imipramine therapy,placebo, and interpersonal psychotherapy couldplay a significantrole in the prevention of recurrence. Use of imipramine hydrochloride,

at an average dosage of 200 mg/d, provided the strongest prophylacticeffect, whereasmonthly interpersonal psychotherapy displayeda modest protective effect, although the

latter was superiorto placebo5and was more pronounced when the psychotherapy was

of higher quality.6-7Extension of treatment with imipramineor placebo providedadditional evidence for the prophylacticeffect of drug treatment.8The clinicalconsequence of thisimportant investigation is that patients with recurrent depression

merit continued antidepressant drug prophylaxis for at least5 years, althoughpsychological therapies also were useful.6-7

Indeed, in a recent study,975 patients with recurrent depressionwere allocated to 3groups: short-term and maintenance (2 years)treatment with antidepressant drugs,cognitive behaviorial treatment(CBT) in the short-term and maintenance phases, andantidepressantuse in the short-term phase and CBT for maintenance. Cognitivetherapydisplayed a similar prophylactic effect to maintenancemedication.9

The criterion for recurrent depression (at least 1 previousepisode of depression) wasdifferent, however, from that endorsedby Frank et al5( 3 episodes of unipolardepression, with theimmediately preceding episode being no more than 2 yearsbefore the onset of the present episode). It is difficultto know, thus, whether thecognitive approach would be effectivealso in a patient population characterized by amore severecourse of illness.5

In earlier studies,10-11an alternative treatment strategy fordecreasing the relapse rateof major depression was developed.This strategy is based on the fact that the presenceof residualsymptoms after completion of drug or psychotherapeutic treatment has beencorrelated with poor long-term outcome1and that someresidual symptoms of major

depression may progress to prodromal symptoms of relapse.12In those studies,10-1140patients withprimary major depressive disorder who had been successfullytreated withantidepressant drugs were randomly assigned toeither CBT of residual symptoms orstandard clinical management(CM).10In both types of treatment, antidepressant drugsweregradually tapered and discontinued. The CBT group had a significantlylower levelof residual symptoms after discontinuation of drugtherapy than the CM group.Cognitive behavioral treatment alsoresulted in a significantly lower rate of relapse(35%) at 4-yearfollow-up than did CM (70%).11

The purpose of this study was to apply this therapeutic approachto a sample ofdepressed patients, whose clinical features matchedthose in the study by Frank et al5on recurrent depression,and to compare the effectiveness of this approach with thatof

standard CM without the use of CBT. In both types of treatment,antidepressant druguse was gradually tapered and discontinued.In view of the considerable clinicalchallenge, CBT of residualsymptoms was supplemented by relapse preventivestrategies.

PATIENTS AND METHODS

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PATIENTS

Forty-five consecutive outpatients satisfying the criteriadescribedbelow who had been referred to and treated in the AffectiveDisordersProgram of the University of Bologna School of Medicine,Bologna, Italy, were enrolledin the study. The patients' diagnoseswere established by the consensus of apsychiatrist (G.A.F.)and a clinical psychologist (C.R.) independently using the Schedule

for Affective Disorders and Schizophrenia.13Patients had tomeet the following criteria:(1) a current diagnosis of majordepressive disorder according to the ResearchDiagnostic Criteriafor a Selected Group of Functional Disorders14;(2) 3 or more

episodes of depression, with the immediately preceding episodebeing no more than 2years before the onset of the present episode5;(3) a minimum 10-week remission

accordingto Research Diagnostic Criteria ( 2 symptoms present to no morethan a milddegree with absence of functional impairment) betweenthe index episode and theimmediately preceding episode5;(4)a minimum global severity score of 7 for thecurrent episodeof depression15;(5) no history of manic, hypomanic, or cyclothymic

features; (6) no history of active drug or alcohol abuse ordependence or of personality

disorder according to DSM-IVcriteria16;(7) no history of antecedent dysthymia; (8) noactive medicalillness; and (9) successful response to antidepressant drugsadministeredby 2 psychiatrists (S.G. and S.C.) according toa standardized protocol.17The latterprotocol involved theuse of tricyclic antidepressant drugs, with gradual increasesindosages. Patients who could not tolerate tricyclic antidepressantdrugs were switched toselective serotonin reuptake inhibitors(Table 1).

View this table:[in this window]

[in a new window]

Table 1. Sociodemographic and Clinical Characteristics of

Patients Assigned to Cognitive Behavioral Treatment (CBT) ofResidual Symptoms or Clinical Management (CM)*

After drug treatment, all patients were assessed by the samepsychologist (C.R.) whohad evaluated them on intake but who did not take part in the treatment. Only patientsrated as "better"or "much better" according to a global scale of improvement15and asbeing in full remission19were included in the study.Patients also had to show noevidence of depressed mood aftertreatment according to a modified version of thePaykel ClinicalInterview for Depression (CID).20Patients fit the criteriafor stage 3 (the

residual phase) of unipolar depression according

to a staging system developedpreviously.21Written informedconsent was secured from all patients.

All patients were treated for 3 to 5 months with full dosesof antidepressant drugs(Table 1), after which the modifiedversion of the CID was administered by the clinicalpsychologist.This interview covered 19 symptom areas, as described in detail

elsewhere.10Each item is rated on a 1- to 7-point scale, with1 indicating absence ofsymptoms and 7, very incapacitatingsymptoms. The scale includes a wider range ofsymptoms (suchas irritability and phobic anxiety) compared with other scalesand isparticularly suitable for assessing subclinical symptomsof affective disorders,22-27also inview of its capacity tomeasure small increments or small changes near the normal end

of the spectrum.10,22Furthermore, it has been fully and independentlyvalidated for

Italian populations.

24-26,28-31

CommentAuthor informationReferences
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TREATMENT

After assessment with the CID, the 45 patients were randomlyassigned to 1 of 2treatment groups: (1) pharmacotherapy andCBT or (2) pharmacotherapy and CM. Inboth groups, treatmentconsisted of ten 30-minute sessions once every other week.Antidepressantdrug use was tapered at the rate of 25 mg of amitriptyline hydrochloride

or its equivalent every other week, and then the drugs werewithdrawn completely (inthe last 2 sessions, all patients weredrug free). Discontinuation of antidepressant druguse was notfeasible for 5 patients (3 in the CBT group and 2 in the CMgroup), and theywere excluded from the study at that point.The same psychiatrist (G.A.F.) performedall treatments in bothgroups.

Cognitive behavioral treatment consisted of the following 3 main ingredients: (1) CBT ofresidual symptoms of major depression.10,32Cognitive therapy was conducted asdescribed by Beck et al.33-34The psychiatrist (G.A.F.), an experienced therapist, usedstrategiesand techniques designed to help depressed patients correct theirdistortedviews and maladaptive beliefs, particularly regardingsymptoms concerned with anxietyand irritability, which constitutethe bulk of residual symptoms in patients with

depression.10Whenever appropriate, as in the case of residual symptoms relatedtoanxiety, exposure strategies were planned with the patient,35eg, in the case ofexposure to phobic external cues in agoraphobiaor social phobia.25(2) Lifestylemodification. Patients wereinstructed that depression is merely the consequence of amaladaptivelifestyle, which does not take life stress, interpersonal friction,excessivework, and inadequate rest into proper account. Antidepressantdrugs restore normalmood, but relapse may ensue if inappropriatelifestyle behaviors are continued afterdrug withdrawal. Patientswere encouraged to modify their schedules, arrangements,etc,accordingly. The strategies used technically derived from lifestyle modificationapproaches that were effective in clinical cardiologicalstudies.36(3) Well-being therapy.In the last 2 or 3 sessions,a psychotherapeutic strategy for enhancing well-being37was

used. The technique is aimed at changing beliefs and attitudesdetrimental to well-

being, stimulating awareness of personalgrowth and recovery from affective illness, andreinforcingbehavior promoting well-being.37It is based on Ryff and Singer's38

conceptual model of well-being as the result of self-acceptance,positive relations withothers, autonomy, environmental mastery,purpose in life, and personal growth.

Clinical management consisted of monitoring medication tapering,reviewing thepatient's clinical status, and providing the patientwith support and advice if necessary.In CM, specific interventionssuch as exposure strategies, diary work, and cognitiverestructuringwere proscribed. The patient was encouraged to share the maineventsthat took place in the previous 2 weeks. Treatment integritywas checked by submitting8 randomly selected taped sessions(4 involving CBT and 4 involving CM) to 2independent assessors,who correctly identified all sessions.

The 40 patients were reassessed with the CID, after treatmentand while drug free, bythe same clinical psychologist (C.R.)who had performed the previous evaluations andwho was unawareof treatment assignment. The patients were then assessed 3,6, 9,12, 15, 18, 21, and 24 months after treatment. They wereinstructed to callimmediately if any new symptoms appearedand were guaranteed a renewed course ofantidepressant drugtherapy only in the event of relapse. Follow-up evaluation consisted

of a brief update of clinical and medical status, includingany treatment contacts or useof medications. Relapse was definedas the occurrence of a Research DiagnosticCriteriadefinedepisode of major depression. During follow-up (unless a relapse

occurred), no patient received additional antidepressant drugtreatment orpsychotherapeutic intervention.

STATISTICAL METHODS
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The 2-tailed ttest and the 2test were used to compare the2 groups and to evaluatechanges in residual symptoms withineach of the treatment groups. Analysis ofcovariance was usedfor comparing the means of the residual symptoms scores, with

adjustment for any difference in the first assessment. Survivalanalysis39was used fortime until relapse into major depression.Six factors were investigated as possiblepredictors of outcome:assignment to CBT or CM, age, sex, duration of the depressive

episode, number of previous depressive episodes, and numberof residual symptomsregardless ofand beforetreatmentassignment. The Kaplan-Meier method was usedfor estimatingsurvival curves. Because relapse was the event of interest, survival refersto relapse-free status. Each factor was dichotomizedwith a cutoff point around themedian for measurement-type factors.The log-rank test and the Cox proportionalhazards regressionmodel were used to compare any 2 survival distributions foreach ofthe 6 factors considered. For all tests performed, thesignificance level was .05, 2-tailed.Results are expressedas mean (SD).

RESULTS

Forty patients (20 in each group) completed the 20-weekexperiment.There were no significant differences between thegroups inany of the variables listed inTable 1or in severity ofresidualsymptoms as measured by the CID (Table 2).Comorbidity was consideredonly if it persisted after treatmentof acute depression andsatisfied Research Diagnostic Criteria.14A few patients weretaking benzodiazepines at low doses andcontinued to do so throughoutthe study.

View this table:[in this window]

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Table 2. Scores at the Clinical Interview for Depression (CID)Before and After Cognitive Behavioral Treatment (CBT) ofResidual Symptoms or Clinical Management (CM)

Cognitive behavioral treatment induced significant improvementin residual symptoms,whereas there were no significant changesin the CM group. When the residual

symptoms at the second assessment

(after CBT or CM) of the groups were compared,with their initialmeasurements as covariates, a significant effect of CBT wasfound(F1,37=31.54, P


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Proportions of depressed patients remaining inremission 2 years after cognitive behavioraltherapy or clinical management.

COMMENT

This study has obvious limitations because of its preliminary

nature. First, it involved a small number of patients in the

evaluation of long-term effects. Second, it had a seminaturalistic

design because patients were initially treated with different

types of antidepressant drugs, and there was no placebo-controlledwithdrawal of medication. Finally, treatment wasprovided byonly 1 psychiatrist with extensive experience inaffective disordersand CBT. The results might have been different with multiple,less

experienced therapists. Nonetheless, the study provides

new, important clinical insightsregarding the treatment ofrecurrent, unipolar, major depressive disorder.

Short-term CBT after successful antidepressant drug therapyhad a substantial effect onrelapse rate after discontinuationof antidepressant drugs. Patients who received CBTreporteda substantially lower relapse rate (25%) during the 2-year follow-upthan thoseassigned to CM (80%). This difference was significantin terms of comparison of meansurvival time and survival analysis.The high relapse rate in the CM group is in line withthe findingsby Frank et al.5However, the patients assigned to CM in thestudy by Franket al had a much shorter survival time than thosein this investigation. This may be dueto the very slow taperof antidepressant drugs that was endorsed by this study because

this may affect outcome in mood disorders.40For 5 patientsnot included in the study,discontinuation of antidepressantdrug therapy was not feasible, suggesting that thelong-termoutlook of recurrent depression is grim if patients are leftwithout appropriatepharmacological support or have not receivedpsychotherapy.

The results of this investigation lend support to the findingson the importance ofpsychotherapy in recurrent depression byFrank et al,5-6Spanier et al,7and Blackburnand Moore.9Resultsof the latter study,9which had less stringent criteria forrecurrentmajor depression, suggest the possibility that both short-term and maintenancetreatment with cognitive therapymay yield better results than pharmacotherapyfollowed by psychotherapy.This possibility, which is intriguing also in light ofsensitizationhypotheses related to antidepressant use,40-42should be exploredwithfuture investigations.

Cognitive behavioral treatment was effective in decreasing residualsymptoms ofdepression, replicating previous results.1By deferringthe psychotherapeutic

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intervention until after pharmacotherapy,we were able to provide a less intensivecourse of therapy (10sessions) than is customary (eg, 16-20 sessions) becausepsychotherapycould be concentrated only on the symptoms that did not abateafterpharmacotherapy. The fact that most of the residual symptomsof depression are alsoprodromal,10and that prodromal symptomsof relapse tend to mirror those of the initialepisode,43explainsthe protective effect of this targeted treatment. Cognitivebehavioral

treatment may act on those residual symptoms of majordepression that progress tobecome prodromal symptoms of relapse.12This may particularly apply to anxiety andirritability, whichare prominent in the prodromal phase of depression,43-44maybecovered by mood disturbances but are still present in theacute phase,45and are again aprominent feature of its residualphase.1,10Substantial comorbidity concerned withanxiety disorderswas found in both groups. Compared with results of the previous

investigation,10CBT was not targeted to decreasing residualsymptoms only. Twoadditional ingredients were added in viewof the clinical challenge represented by apatient populationwith recurrent depression. One was defined as lifestyle modification.

Clinical experience has suggested that recovered depressed patientsare often unawareof the long-term consequences of a maladaptivelifestyle, which does not take long-term, minor life stress;interpersonal friction; excessive work (particularly in male

professionals 40-50 years old); and inadequate rest into properaccount. Althoughlifestyle modification often has been incorporatedin relapse preventive strategies indepression,46it has beenspecifically addressed mainly in the clinical cardiologicalarena(eg, modification of type A behavior after myocardialinfarction).36We postulated thatthe presence of subsyndromalpsychiatric symptoms47and long-term stress exposuremay causean allostatic load, ie, fluctuating and heightened neural orendocrineresponses resulting from environmental challenge.48Furthermore, interventions thatbring the person out of negativefunctioning (eg, exposure treatment in panic disorderwith agoraphobia25) are one form of success, but facilitating progression toward

restoration of the positive is another.38Ryff and Singer38suggested that the absence ofwell-being creates conditionsof vulnerability to possible future adversities. A specific

psychotherapeutic strategy that enhances well-being37was thethird main ingredient of

the CBT approach. It is not possible

to know from our study whether these 2 additionalingredients(lifestyle modification with the ensuing sense of control andwell-beingtherapy) yielded specific contributions to the clinicalresults obtained in ourinvestigation. In an independent, preliminary,small-scale study,37a significantadvantage of well-being therapyover standard CBT strategies in decreasing residualsymptomswas observed. Further research should elucidate these points.

The results of studies by Frank et al,5-6Spanier et al,7andKupfer et al8alerted theclinician to the need for providingmaintenance therapies to patients with recurrentdepression.Long-term, high-dose antidepressant drugs seemed to be the treatmentofchoice. This preliminary investigation, using a similar patientpopulation, wouldchallenge such a stance and confirm the unfavorablelong-term outcome of patients not

receiving pharmacotherapy

or psychotherapy. Long-term maintenance drug treatment3-4

orpsychotherapy4,49may be necessary in several patients. However,our approach (CBTafter pharmacotherapy) does not fall withinthe realm of maintenance strategies. It is a2-stage, sequential,intensive approach that is based on the fact that treatmentofdepression by pharmacological means is likely to leave a substantial amount of residualsymptoms in most patients.1Whetherthey reach the threshold of comorbidity, theseresidual symptomshinder lasting recovery. The findings of this preliminary investigation

await further large-scale, independent replications. If theeffectiveness of this approachis established, the result mighthave important implications for the clinician and forcurrentconceptualizations of affective disorders.50

AUTHOR INFORMATION
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Accepted for publication June 3, 1998.

This work was supported in part by grants from the "MentalHealthProject," Istituto Superiore di Sanit (Dr Fava), andthe"Ministero dell Universit e della Ricerca ScientificaeTecnologica" (Dr Fava and Fortunato Pesarin, PhD), Rome, Italy.

Dr Pesarin, University of Padova, Padova, Italy, provided statisticaladvice.

Reprints: Giovanni A. Fava, MD, Department of Psychology, Universityof Bologna, vialeBerti Pichat 5, 40127 Bologna, Italy.

From the Department of Psychiatry, State University of New York at Buffalo (Dr Fava),and the Affective Disorders Program and Laboratory of Experimental Psychotherapy,Department of Psychology, University of Bologna, Bologna (Drs Fava, Rafanelli, Grandi,

and Conti), and the Department of Statistical Sciences, University of Padova, Padova(Dr Belluardo), Italy.

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