Brown_RCT_2005_OPTIONAL.pdf

ORIGINAL CONTRIBUTION

Cognitive Therapy for the Preventionof Suicide AttemptsA Randomized Controlled TrialGregory K. Brown, PhDThomas Ten Have, PhDGregg R. Henriques, PhDSharon X. Xie, PhDJudd E. Hollander, MDAaron T. Beck, MD

IN 2002, SUICIDE WAS THE FOURTHleading cause of death for adults be-tween the ages of 18 and 65 yearswith approximately 25 000 sui-cides for this age group in the UnitedStates.1 As recommended by the Na-tional Strategy for Suicide Prevention, onepublic health approach for the preven-tion of suicide involves identifying andproviding treatment for those individu-als who are at high risk for suicide.2

Attempted suicide is one of the stron-gest risk factors for completed suicidein adults. A meta-analysis of fol-low-upmortality studies estimated thatindividualswho attempted suicidewere38 to 40 times more likely to commitsuicide than those who had not at-tempted suicide.3 Prospective re-search also has supported the validityof attempted suicide as a risk factor foreventual suicide.4-7

Empirical evidence for treatmentsthat effectively prevent repetition of sui-cide attempts is limited.8 Randomizedcontrolled trials of individualswhohaveattempted suicide have used intensivefollow-up treatment or intensive casemanagement,9-11 interpersonal psy-

chotherapy,12 or cognitive behaviortherapy.13 Several studies supporting theefficacy of cognitive behavior therapyor problem-solving therapy for reduc-ing suicide behavior13,14 have high-lighted the need for randomized con-trolled trials with sufficient power todetect treatment differences.15For editorial comment see p 623.

Author Affiliations: Departments of Psychiatry (DrsBrown and Beck) and Emergency Medicine (DrHollander) and Center for Clinical Epidemiology andBiostatistics (Drs TenHave andXie), University of Penn-sylvania, Philadelphia; and Department of Graduate-Psychology, James Madison University, Harrison-burg, Va (Dr Henriques).Corresponding Author: Gregory K. Brown, PhD, De-partment of Psychiatry, University of Pennsylvania,3535Market St, Room 2030, Philadelphia, PA 19104([email protected]).

Context Suicide attempts constitute a major risk factor for completed suicide, yet fewinterventions specifically designed to prevent suicide attempts have been evaluated.

Objective To determine the effectiveness of a 10-session cognitive therapy inter-vention designed to prevent repeat suicide attempts in adults who recently attemptedsuicide.

Design, Setting, and Participants Randomized controlled trial of adults (N=120)who attempted suicide and were evaluated at a hospital emergency department within48 hours of the attempt. Potential participants (N=350) were consecutively recruitedfrom October 1999 to September 2002; 66 refused to participate and 164 were in-eligible. Participants were followed up for 18 months.

Intervention Cognitive therapy or enhanced usual care with tracking and referralservices.

MainOutcomeMeasures Incidence of repeat suicide attempts and number of daysuntil a repeat suicide attempt. Suicide ideation (dichotomized), hopelessness, and de-pression severity at 1, 3, 6, 12, and 18 months.

Results From baseline to the 18-month assessment, 13 participants (24.1%) in thecognitive therapy group and 23 participants (41.6%) in the usual care group made atleast 1 subsequent suicideattempt (asymptotic z score, 1.97;P= .049).Using theKaplan-Meiermethod, theestimated18-monthreattempt-freeprobability in thecognitive therapygroup was 0.76 (95% confidence interval [CI], 0.62-0.85) and in the usual care groupwas 0.58 (95% CI, 0.44-0.70). Participants in the cognitive therapy group had a sig-nificantly lower reattempt rate (Wald 21=3.9; P=.049) and were 50% less likely to re-attempt suicide than participants in the usual care group (hazard ratio, 0.51; 95% CI,0.26-0.997). The severity of self-reporteddepressionwas significantly lower for the cog-nitivetherapygroupthanfortheusualcaregroupat6months(P=.02),12months(P=.009),and 18months (P=.046). The cognitive therapy group reported significantly less hope-lessness than the usual care group at 6months (P=.045). Therewere no significant dif-ferences between groups based on rates of suicide ideation at any assessment point.

Conclusion Cognitive therapy was effective in preventing suicide attempts for adultswho recently attempted suicide.JAMA. 2005;294:563-570 www.jama.com

2005 American Medical Association. All rights reserved. (Reprinted) JAMA, August 3, 2005Vol 294, No. 5 563

at PATTERSON LIBRARY, on August 2, 2005 www.jama.comDownloaded from

This study was designed with ad-equate power to determine whether abrief psychosocial intervention couldreduce the rate of repetition for sui-cide attempts over an 18-month inter-val, a longer period than previously re-ported in most randomized controlledtrials. Cognitive therapy was selectedas the psychosocial intervention for thisstudy because it builds on clinical in-vestigations regarding the psychopatho-logical characteristics of suicide behav-iors16 and it has been shown to besuccessful in a wide variety of psychi-atric disorders.17 We examined 3 hy-potheses. First, the hazard ratio for an-other suicide attempt would be lowerin the cognitive therapy group com-pared with the usual care group. Sec-ond, during follow-up, the proportionof participants who attempt suicidewould be lower in the cognitive therapygroup compared with the usual caregroup. Third, participants in the cog-nitive therapy group would have sig-nificantly lower scores on measures ofdepression, hopelessness, and suicideideation during follow-up comparedwith the participants in the usual caregroup.

METHODSParticipants

The study sample consisted of 120 indi-vidualswho attempted suicide andwhoreceived amedical or psychiatric evalu-ation within 48 hours of the attempt.Individualswere initially identified in theemergency department following a sui-cide attempt or intentional self-injury(eg, overdose, laceration, gunshotwound) at the Hospital of the Univer-sityofPennsylvania,Philadelphia.18Afterthe patients were medically cleared orstabilized in the emergency depart-ment, they were transferred to the psy-chiatric emergency department. Eli-gible individuals were identified byresearch assistants in the emergencydepartment during the initial evalua-tion and through screening intake logsat thepsychiatricemergencydepartment.Individuals admitted to an inpa-

tient unit of the hospital were con-tacted by research assistants after ob-

taining permission from the attendingphysician. Potential participants whowere not admitted to an inpatient unitand discharged were contacted by tele-phone. A brief interview was con-ducted to determine if an attempt hadoccurred with verbal consent ob-tained for the interview. A suicide at-temptwas defined as a potentially self-injurious behavior with a nonfataloutcome for which there is evidence,either explicit or implicit, that the in-dividual intended to kill himself or her-self.19(p247) The Suicide Intent Scalewasused to ascertain suicide intent.20 Forthose acts in which it was not clearwhether a self-harmful act was an ac-tual suicide attempt, study investiga-tors were consulted to achieve consen-sus regarding an individuals studyeligibility.A complete description of the study

was provided to potential participantsand signed written informed consentwas obtained by study personnel. Theinstitutional review board at the Uni-versity of Pennsylvania and an inde-pendent data and safety monitoringboard approved andmonitored the re-search protocol.Inclusion criteria consisted of a sui-

cide attempt within 48 hours prior tobeing evaluated at the emergency de-partment; age of 16 years or older; abil-ity to speak English; ability to com-plete a baseline assessment; ability toprovide at least 2 verifiable contacts toimprove tracking for subsequent as-sessments; and ability to understandand provide informed consent. Indi-viduals were excluded if they had amedical disorder that would preventparticipation in an outpatient clinicaltrial. Individuals were not asked or re-quired to discontinue any form ofmen-tal health or substance abuse treat-ment prior to entering the study.An in-person baseline interview and

self-report inventories were adminis-tered within 3 days but no longer than3 weeks after the suicide attempt bytrained clinicians who heldmasters ordoctoral degrees. Psychiatric diag-noses were determined by clinicianstrained in administering the Struc-

turedClinical Interview for Axis I of theDiagnostic and StatisticalManual ofMen-tal Disorders, Fourth Edition21 and by astudy psychologistwho reviewed symp-toms. Subsequent in-person assess-ments were conducted independentlyof study therapists at 1, 3, 6, 12, and18 months following the baseline in-terview.

Random Assignment

Participants (N=120) were randomlyassigned to cognitive therapy or usualcare. A computerized randomization se-quence programmed to prohibit morethan 7 consecutive assignments ineither treatment group was used. Al-though blinded assessments were con-ducted at baseline, blinded follow-upevaluations were not possible for 2 rea-sons. First, the evaluation of a suicideattempt involved an investigation of thecircumstances preceding the self-harmful act and the postattempt use ofmental health services, which pre-sented clues to the group assignment.Second, information regarding treat-ment assignmentwas often essential foradequate clinical management ofacutely suicidal individuals.22,23

Comparison Conditions

Participants in the cognitive therapy in-terventionwere scheduled to receive 10outpatient cognitive therapy sessionsspecifically developed for preventingsuicide attempts.24-26 The cognitivetherapy sessions were provided on aweekly or biweekly basis or as needed.The central feature of this psycho-therapywas the identification of proxi-mal thoughts, images, and core beliefsthat were activated prior to the sui-cide attempt. Cognitive and behav-ioral strategies were applied to ad-dress the identified thoughts and beliefsand participants were helped to de-velop adaptive ways of coping withstressors. Specific vulnerability fac-tors thatwere addressed includedhope-lessness, poor problem solving, im-paired impulse control, treatmentnoncompliance, and social isolation.A relapse prevention task was con-ducted near the end of therapy. The ob-

COGNITIVE THERAPY VS USUAL CARE TO PREVENT SUICIDE

564 JAMA, August 3, 2005Vol 294, No. 5 (Reprinted) 2005 American Medical Association. All rights reserved.


jective of this task was to prime, in ses-sion, the specific thoughts, images, andfeelings associatedwith prior suicide at-tempts and to determine if partici-pants were able to respond to theirproblems in an adaptive way. Success-ful completion of this task was justifi-cation for completion of the treat-ment. If the participant failed to respondadaptively, additional sessions wereprovided. All cognitive therapy ses-sions were audiotaped and each thera-pist was rated for competency using theCognitive TherapyRating Scale.27 Feed-back was provided to therapists bi-weekly or as needed if therapists did notadhere to the treatment manual.Participants in both study groups re-

ceived usual care from clinicians in thecommunity as well as tracking and re-ferral services from the study caseman-agers.28 In both conditions, study casemanagers obtained detailed contact in-formation regarding participants fam-ily, friends, clergy, probation officers,and mental health workers. These in-dividuals were contacted by case man-agers with permission from the partici-pants if they could not be contacted.Case managers contacted participantsthroughout the follow-up period on aweekly tomonthly basis bymail and bytelephone using a community voicemail account. Additionally, case man-agers offered referrals to communitymental health treatment, addictiontreatment, and social services (asneeded during the follow-up period)and obtained feedback from partici-pants regarding their contactwith theseservices. Although participants in bothconditionswere encouraged to seek ad-ditional mental health and substanceabuse treatment in the community, thestudy did not cover the costs of theseinterventions.

Outcome Measures

The primary outcomemeasure was theoccurrence of a suicide attempt dur-ing the follow-up period. The inter-viewer assessed suicide attempts byparticipant report. The clinician-administered 24-item Hamilton Rat-ing Scale for Depression (HRSD)29 and

the self-reported 21-item Beck Depres-sion Inventory II30 were used to assessthe severity of depression. Hopeless-ness was measured by the Beck Hope-lessness Scale, which consisted of 20true or false statements designed to as-sess the extent of positive and nega-tive beliefs about the future.31 The 19-itemScale for Suicide Ideation evaluatedthe intensity of the participants spe-cific attitudes, behaviors, and plans tocommit suicide.32 Because the distri-bution of scores for the Scale for Sui-cide Ideation is highly skewed, it wasdichotomized at 0 (vs 0) to indicateany current suicide ideation.33

Safety Assessment andManagement

At any point in the study, participantswhowere suspected to be at risk for sui-cide were asked the following ques-tions by a doctoral-level clinician: (1)Do youhave a desire to kill yourself thatyou think youmight act on? (2)Do youhave a plan for killing yourself and in-tend to carry the plan out? Partici-pants were also identified as high riskif they reported a moderate to severelevel of suicide intent as indicated onother self-report measures or during aclinical interview. A participant ran-domized to either study group was re-ferred or transferred to the emergencydepartment if the clinician deter-mined that he/shewas at imminent riskfor suicide and could not be safelytreated on an outpatient basis. Partici-pantswhowere hospitalized during thefollow-up period were allowed to con-tinue with treatment and assessmentsafter they were discharged. All suicideattempts and deaths were reported tothe institutional review board and dataand safety monitoring board.

Sample Size and Power Estimates

To test the primary hypothesis that themean time to the next suicide attemptduring the follow-up period is differ-ent between treatment groups, a prioripower calculationswere basedon the re-sults of a previous randomized con-trolled trialwith a similar protocol.13 Thecurrent sample size (N=120) provided

at least 80%power to detect a hazard ra-tio of 0.44 in terms of time to next sui-cide attempt between treatment groupsusing an assumed repeat attempt rate of25.8% during the follow-up period anda 2-sided level of .05.34

Statistical Methods

Data entry and verification, data trans-fer, confidentiality and security, anddata analyseswere conducted under thedirection of the principal investiga-tors and statisticians. All effectivenessanalyses were conducted using the in-tent-to-treat (ITT) principle, which in-cluded all randomized participants inthe treatment groups to which theywere assigned regardless of their pro-tocol adherence, actual treatment re-ceived, and/or subsequent withdrawalfrom treatment or assessment. Descrip-tive statistics for assessment scores atbaseline were compared between treat-ment groups to determine if any vari-ables needed to be included as covari-ates in the primary analyses of treatmenteffects.Survival analyseswere conducted us-

ing the Cox proportional hazard re-gression model35 to test for the effec-tiveness of the intervention on the timeto the first repeat suicide attempt whilecontrolling for censoring effects due tothe differential length of follow-up orthe completion of follow-up without arepeat suicide attempt. Length of fol-low-up for each participant was repre-sented by either the number of days be-tween the date of baseline evaluationand the date of the repeat suicide at-tempt or the end of the follow-up pe-riod, whichever came first. Single andmultiple covariate Cox proportionalhazards regression models were used.Associated Wald 2 tests were con-ducted using a significance level of .05(2-sided) to test the null hypothesis thatthe 2 reattempt-free probabilities werethe same for the cognitive therapy andusual care groups at any time point. Toconfirm the single covariate Coxmodelresults, the results of the log-rank testalso were reported. Estimates of par-ticipants making at least 1 subsequentsuicide attempt before 18 months and




reattempt-free probabilities at any timepoint were derived by the Kaplan-Meier method.36 The between-groupdifference in the proportion of partici-pants making at least 1 repeat suicideattempt by 18monthswas evaluated us-ing the asymptotic properties of theKaplan-Meier estimators of survivalprobabilities. This method was cho-sen to account for dropouts based onthe ITT principle.To examine whether cognitive

therapy reduced suicide ideation, hope-lessness, and depression more thanusual care, comparisons between the 2study groups were conducted on con-tinuousmeasures. Analyses of repeated-measures data were performed to de-termine and characterize the patternsof change over time between treat-ment groups. Although procedureswere developed for maintaining fol-low-up during the assessment period,missing data and loss to follow-up areinevitable. By using latent random-effects variables for each participant, hi-erarchical linear (or logit) modelingpermits estimation of changes in re-peated measures without necessitat-ing last observation carried forward orexclusion of participants with missing

data. We used SAS software version 8(SAS Institute Inc, Cary, NC) for all sta-tistical analyses.Tests and estimates of ITT differ-

ences for both continuous and binaryoutcomes were based on longitudinalmodels with random effects. The lon-gitudinal random-effects models in-cludedmain effect and interaction termsthat represented ITT contrasts be-tween groups at each follow-up visit.Using data from all participants regard-less of dropout or treatment adher-ence status, thismodeling allowed test-ing of ITT differences at each follow-upvisit separately and together with in-creased power while accounting forgroup differences with respect to par-ticipants who dropped out. We firsttested for significant ITT differences inlinear trend for each outcome. How-ever, the linear trend model did not fitany of the outcomes well so we reliedon separate ITT tests of the 5 fol-low-up visits using separate visit-treatment interactions at each visit andalso jointly across all 5 visits using anomnibus visit-treatment interaction testwith 5 degrees of freedom. The omni-bus statistic tests for significant ITT con-trasts at any particular follow-up visit

using a time group interaction with 5degrees of freedom.37-39 To assess ITTdifferenceswith respect to dropouts, weused a discrete time survival model.40

Two-sided P values are presented un-adjusted for multiple comparisons sothat adjustment of choice, such as us-ing the Bonferroni adjustment, may beperformed by the reader.

RESULTSEnrollment Statistics

Over a 2-year period (October 2000 toSeptember 2002), 350 individualswereinvited toparticipate (FIGURE1).Of the230whowere excluded, 164 (71%)didnotmeet inclusioncriteria and66(27%)declined to participate in the study. Formost excluded individuals, we deter-mined that the self-harmful actwas nota suicideattempt.Of thosewhodeclinedto participate, 36 (55%) refused to pro-vide a reason, 21 (32%) did not wishto receive treatment, 4 (6%) declinedfor emotional reasons, and 5 (8%)declined due to situational factors (eg,no child care, no transportation).Of 186 eligible participants, 120

(65%) were enrolled in the study. Theonly demographic variable that wasfound to be related to participationwasethnicity (21=4.9; P= .03). Specifi-cally, blacks were 1.2 times (odds ra-tio, 1.2; 95% confidence interval [CI],1.0-1.5) more likely than whites andother minorities to participate in theclinical trial.

Demographic and ClinicalCharacteristics

Participant age ranged from 18 to 66years and 61% were female. As as-sessed by participant self-report for thepurpose of describing the racial char-acteristics of the sample, 60% wereblack, 35% were white, and 5% wereHispanic, Native American, or unspeci-fied. The racial composition of thesample is similar to the racial compo-sition of the general population in thePhiladelphia areawhere theHospital ofthe University of Pennsylvania is lo-cated. At baseline, 77% had amajor de-pressive disorder and 68% had a sub-stance use disorder. Specific substance

Figure 1. Flow of Participants Through the Trial

350 Assessed for Eligibility

120 Randomized

15 Lost to Follow-up at 18 mo12 No Contact1 Died (Natural Cause)2 Refused

20 Lost to Follow-up at 18 mo16 No Contact2 Died (Natural Cause)1 Died (Suicide)1 Refused

60 Assigned to Receive CognitiveTherapy Plus Usual Care58 Received Cognitive Therapy

as Assigned2 Did Not Receive Cognitive

Therapy1 No Contact1 Refused

60 Assigned to Receive Usual Care60 Received Usual Care as

Assigned

230 Excluded164 Did Not Meet Inclusion Criteria66 Refused to Participate

60 Included in Analysis60 Included in Analysis




use disorders included alcohol (30%),cocaine (23%), and heroin (17%) de-pendence.Most participants (85%) hadmore than 1 psychiatric diagnosis. Themajority of participants (58%) at-tempted suicide by overdosing usingprescription, over-the-counter, or il-licit substances. Other methods werepenetrating injury (17%); jumping(7%); and hanging, shooting, or drown-ing (4%). Participants in the cognitivetherapy and usual care groups did notdiffer significantly ondemographic vari-ables (TABLE 1). The groups did not dif-fer on the incidence of major depres-sive disorder, substance use disorder,or prevalence of suicide ideation at base-line.

Dropout Rates

The cumulative dropout rate at the1-month assessmentwas 10% (n=6) forthe cognitive therapy group and 7%(n = 4) for the usual care group;3-month assessment, 13% (n=8) and10% (n=6); 6-month assessment, 17%(n = 10) and 13% (n = 8); and 12-month assessment, 18% (n=11) and18% (n=11), respectively. The cumu-lative dropout rate at the 18-month fol-low-up assessmentwas 25% (n=15) forthe cognitive therapy group and 34%(n = 20) for the usual care group(Figure 1). Using a discrete time sur-vivalmodel,40 drop-out rates did not dif-fer across all 5 follow-up assessments(P= .36). The proportion of partici-pants with missed assessment visitswas similar between groups; differ-ences did not exceed 8.3% at any visit(P.30).

Repeat Suicide Attempts

From the baseline to the 18-month as-sessment, 13 participants (estimatedproportion: 24.1%) in the cognitivetherapy group and 23 participants(estimated proportion: 41.6%) in theusual care group made at least 1 sub-sequent suicide attempt (asymptoticz score =1.97; P= .049). Using theKaplan-Meier method, the estimated6-month reattempt-free probability inthe cognitive therapy group was 0.86(95% CI, 0.74-0.93) and in the usual

care group was 0.68 (95% CI, 0.54-0.79). In addition, the estimated 18-month reattempt-free probability in thecognitive therapy groupwas 0.76 (95%CI, 0.62-0.85) and in the usual caregroup was 0.58 (95% CI, 0.44-0.70).Kaplan-Meier survival curves illus-trate the differences in repeat suicideattempts between groups over time(FIGURE 2). Results indicated that par-ticipants in the cognitive therapy group(Wald21=3.9;P=.049; log-rank21=4.0;P=.045) had a significantly lower re-attempt rate than those in the usual caregroup (log-rank 21=4.0; P=.045). Thehazard ratio from this analysis was 0.51(95% CI, 0.26-0.997), which suggeststhat participants in the cognitivetherapy group were 50% less likely toattempt suicide during the follow-upperiod than participants in the usualcare group. Additionalmultiple Cox re-

gression models revealed that the im-pact of cognitive therapy remained sig-nificant even when controlling for theeffects of other outcome measures (ie,BeckDepression Inventory, BeckHope-lessness Scale, HRSD, Scale for Sui-cide Ideation) at baseline (hazard ra-tio, 0.47 [95% CI, 0.24-0.93]; P=.03).Although the effect of cognitive therapyshowed only a trend toward signifi-cancewhen controlling for age, sex, andminority status (hazard ratio, 0.52 [95%CI, 0.26-1.02]; P=.06), there was onlya 2% difference between the adjustedand unadjusted hazard ratios. All re-peat suicide attempts were deter-mined to be adverse events that werenot related to the study. The total num-ber of cognitive therapy sessions re-ceived was not related to repeat sui-cide attempt status (OR, 1.08 [95%CI,0.97-1.92]; 21=2.11; P=.14).

Table 1. Baseline Demographic and Clinical Characteristics*

Cognitive Therapy(n = 60)

Usual Care(n = 60) P Value

Women 36 (60.0) 37 (61.7) .99

Age, mean (SD), y 35.1 (10.1) 34.9 (10.5) .90

Minority race/ethnicity 42 (70.0) 36 (60.0) .34

High school education 35 (57.9) 38 (63.3) .58

Employed 14 (23.3) 8 (13.3) .24

Married 9 (15.5) 4 (6.9) .12

Multiple suicide attempts 44 (73.3) 43 (71.7) .99

DiagnosedMajor depressive disorder 47 (78.3) 45 (75.0) .83

Substance use disorder 44 (73.3) 37 (61.7) .24*Data presented as No. (%) except as noted.According to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

Figure 2. Survival Curves of Time to Repeat Suicide Attempt

1.0

0.6

0.5

0.7

0.8

0.9

0.1

0

0.2

0.3

0.4

No. at RiskCognitive TherapyUsual Care

0

6060

6

4536

18

1611

Usual Care

Cognitive Therapy

Log-Rank P = .045

12

3728

Months

Rea

ttem

pt-F

ree

Pro

babi

lity




Secondary Outcome MeasuresThe impact of cognitive therapy onmeasures of depression, hopelessness,and suicide ideation was also exam-ined from 1 to 18 months followingthe baseline assessment (TABLE 2). Theseverity of depression (measured bythe Beck Depression Inventory) wassignificantly lower for the cognitivetherapy group than for the usual caregroup at 6-month (P=.02), 12-month(P= .009), and 18-month (P= .046)assessment points, yielding a signifi-cant overall omnibus test (25=29.9;P.001). Although the overall omni-bus test for the HRSD was significant(25=22.2; P.001), no significant dif-ferences between groups on HRSDwere observed at any assessment point.However, there was significantly lesshopelessness in the cognitive therapygroup than in the usual care group at 6months (P = .045) and the overallomnibus test for the Beck Hopeless-ness Scale was significant (25=19.1;

P.001). There were no differencesbetween groups on the rates of suicideideation overall (Scale for Suicide Ide-ation total score0; 25=1.2; P=.95) orat any assessment visit.

Treatment

Participants in the cognitive therapygroup participated in a mean (SD) of8.92 (5.97) cognitive therapy sessions(range, 0-24). Thirty participants(50%) received 10 or more cognitivetherapy sessions. Additional cognitivetherapy sessions were provided untilparticipants completed the relapse pre-vention task successfully. Twenty-eightparticipants (46.7%) received 1 to 9sessions and 2 participants (3.3%) didnot receive any cognitive therapy. Ofthose participants who received 0 to 9sessions, 21 participants could not belocated and 9 participants refusedtreatment. Additional (nonstudy) treat-ments received by both groups aredescribed in TABLE 3. There were no

significant differences between theusual care and cognitive therapygroups with respect to the proportionof participants receiving psychotropicmedication overall (53.6% vs 51.7%;21=0.3; P=.65) or addiction treatmentoverall (12.9% vs 15.8%; 21= 1.1;P= .36) or at any assessment point.However, there was a trend for a largerproportion of the usual care group toparticipate in nonstudy psychotherapytreatment overall (27.1% vs 20.6%;21=3.6; P= .07) and at the 1-monthassessment, specifically (P= .07). Inaddition, a significantly larger propor-tion of the usual care group comparedwith the cognitive therapy group didnot receive any type of psychotherapy(cognitive therapy or other psycho-therapy), medication, or addictiontreatment overall (31.6% vs 16.8%;21 = 10.0; P.001) or at 1-month(P.001), 3-month (P.001), or6-month (P.001) assessments. Therewas no significant difference between

Table 2. Impact of Cognitive Therapy on Secondary Outcome Measures

Baseline

Assessment Period, mo

1 3 6 12 18

Beck Depression Inventory IICognitive therapy, mean (SD) 32.87 (12.03) 21.80 (15.48) 19.96 (14.82) 13.82 (12.34) 13.59 (13.40) 14.51 (12.90)

Usual care, mean (SD) 31.03 (15.70) 21.66 (15.14) 21.19 (14.92) 19.33 (15.61) 18.73 (14.87) 18.18 (13.75)

Effect (95% CI) 0.3 (5.1 to 4.5) 2.2 (7.0 to 2.60) 6.0 (10.9 to 1.1) 6.7 (11.7 to 1.7) 5.4 (10.6 to 0.1)

t Score 0.13 0.89 2.41 2.63 2.00

P value .90 .37 .02 .009 .046

Hamilton Rating Scale forDepression

Cognitive therapy,mean (SD)

26.88 (10.04) 19.89 (10.88) 17.40 (11.22) 14.70 (11.05) 15.08 (11.44) 13.09 (9.96)


Effect (95% CI) 0.9 (3.2 to 5.0) 2.1 (6.2 to 2.1) 3.5 (7.7 to 0.7) 3.0 (7.3 to 1.3) 3.0 (7.5 to 1.5)

t Score 0.44 0.98 1.64 1.37 1.13

P value .66 .33 .10 .17 .19

Beck Hopelessness ScaleCognitive therapy,

mean (SD)11.48 (5.45) 9.09 (5.91) 7.45 (4.99) 5.57 (4.47) 6.57 (5.76) 6.07 (5.28)


Effect (95% CI) 0.8 (1.1 to 2.6) 1.3 (3.5 to 0.9) 2.0 (4.0 to 0) 1.7 (4.0 to 0.5) 1.3 (3.7 to 1.0)

t Score 0.84 1.16 2.01 1.51 1.14

P value .40 .24 .045 .13 .25

Scale for Suicide Ideation*Cognitive therapy, No. (%) 60 (65.0) 54 (44.4) 52 (38.5) 50 (24.0) 49 (20.4) 45 (15.6)

Usual care, No. (%) 60 (65.0) 56 (46.4) 54 (44.4) 52 (30.8) 49 (24.5) 40 (22.5)

OR (95% CI) 1.0 (0.4 to 2.7) 0.8 (0.3 to 2.1) 0.7 (0.2 to 2.4) 0.8 (0.2 to 2.4) 0.6 (0.2 to 2.2)

P value .99 .66 .49 .63 .41

Abbreviations: CI, confidence interval; OR, odds ratio.*Indicates greater than zero.




groups in the proportion of partici-pants who were determined to be animminent risk and referred or trans-ferred to the emergency departmentby study investigators during thefollow-up period (13.3% of cognitivetherapy group vs 8.3% of usual caregroup; 21=0.8; P=.38).

COMMENTThe results of this randomized con-trolled trial indicated that a relativelybrief cognitive therapy interventionwaseffective in preventing suicide at-tempts for adults who recently at-tempted suicide. Specifically, partici-pants in the cognitive therapy groupwere approximately 50% less likely toattempt suicide during the follow-upperiod than participants in the usualcare group.The severity of depression as mea-

sured by the Beck Depression Inven-torywas significantly lower for the cog-nitive therapy group than for the usualcare group at the 6-month, 12-month,and 18-month assessments. Althoughthere were no significant differences inthe severity of depression as measuredby the HRSD at any assessment point,the superiority of cognitive therapywassignificant overall. The discrepancybetweenmeasures of depression sever-ity across assessment pointsmay be dueto differences in the type of assess-mentmethods (self-report vs clinician-administered).41

The cognitive therapy group also hadsignificantly less hopelessness than theusual care group at 6 months. Previousresearch has indicated that partici-pants whose hopelessness did not sig-nificantly changewith psychiatric treat-ment may be more likely to commitsuicide.42 Moreover, results from a pre-vious clinical trial indicated that stablelevels of hopelessness in individualswithremitted depression are more predic-tive of a suicide attempt than ahigh levelof hopelessness at any 1 time point.43

These results are consistent with aprevious randomized controlled trial ofsuicide attempters that compared cog-nitive behavior therapy andusual care.13

That study found that cognitive therapy

had an impact on the proportion of par-ticipants repeating a suicide attempt atthe 6-month follow-up period. Similarto our results, the previous study re-ported that cognitive therapy partici-pants improved significantly more onself-reportedmeasuresof depressionandhopelessness but not suicide ideation.Althoughboth groups demonstratedde-creased suicide ideation in the presentstudy, the differential impact of cogni-tive therapy on depression and hope-lessness suggests that improvement onthese variables may be more highly as-sociated with a reduced risk of repeatsuicide attempts.Given the results of thepresent and previous studies, further re-search that examines the effectiveness

of the techniques specific to cognitivetherapy is warranted.The generalizability of these find-

ingsmay be limited to suicide attempt-ers who reside in an urban setting andwho are evaluated at an emergency de-partment. In addition, given that a largerproportion of the sample who con-sented to the study was black, addi-tional research is required to investi-gate this possible participation bias.As indicated by a sensitivity analy-

sis, another study limitation concernsthe possibility that small changes in thenumber of suicide attempts during thefollow-up periodmay affect the signifi-cance of the results. However, the re-sults of our study are strengthened by

Table 3. Types of Treatment Received by Participants in the Cognitive Therapy Group vs theUsual Care Group Over Time*

Unadjusted Estimates,No. (%)

Analysis for CognitiveTherapy vs Usual Care

Cognitive Therapy(n = 60)

Usual Care(n = 60)

OR(95% CI)

PValue

At 1 moCognitive therapy 55 (91.7) 0 1.0

Other psychotherapy 5 (9.3) 13 (23.2) 0.3 (0.1-1.0) .07

Medication 36 (60.0) 42 (70.0) 0.6 (0.3-1.4) .34

Addiction treatment 7 (13.0) 6 (10.7) 1.2 (0.4-4.0) .77

No treatment 1 (1.7) 13 (23.2) 0.1 (0-0.5) .001



Medication 34 (56.7) 39 (65.0) 0.7 (0.3-1.5) .46


No treatment 1 (1.8) 12 (22.2) 0.1 (0-0.5) .001



Medication 28 (46.7) 26 (43.3) 1.1 (0.6-2.4) .86


No treatment 6 (12.0) 21 (40.4) 0.2 (0.1-0.6) .001



Medication 21 (35.0) 23 (38.3) 0.9 (0.4-1.8) .85


No treatment 14 (27.5) 21 (43.8) 0.5 (0.2-1.1) .10



Medication 20 (33.3) 18 (30.0) 1.2 (0.5-2.5) .85


No treatment 20 (43.5) 17 (42.5) 1.0 (0.4-2.5) .99Abbreviations: CI, confidence interval; OR, odds ratio.*Treatment categories are not mutually exclusive.




the consistency of the results across sev-eral outcomes (ie, suicide attempts, de-pression, and hopelessness).An important goal of the National

Strategy for Suicide Prevention is toimprove community linkages withprimary care and mental health/substance abuse health systems fortranslating evidence-based treatmentsinto community-based settings.2 Theshort-term feature of cognitive therapywould make it particularly applicablefor the treatment of suicide attempt-ers at community mental health cen-ters, which typically provide rela-tively short-term therapy. Additionalstudies are warranted to examine thefeasibility, effectiveness, and cost-effectiveness of this intervention incommunity-based mental health andsubstance use treatment settings.

Author Contributions:Dr Brown had full access to allof the data in the study and takes responsibility forthe integrity of the data and the accuracy of the dataanalysis.Study concept and design: Brown, Ten Have,Henriques, Hollander, Beck.Acquisition of data: Brown, Ten Have, Henriques,Hollander, Beck.Analysis and interpretation of data: Brown, Ten Have,Xie, Beck.Drafting of the manuscript: Brown, Ten Have, Beck.Critical revision of the manuscript for important in-tellectual content: Brown, Ten Have, Henriques, Xie,Hollander, Beck.Statistical analysis: Brown, Ten Have, Xie.Obtained funding: Brown, Ten Have, Beck.Administrative, technical, or material support: Brown,Ten Have, Henriques, Hollander, Beck.Study supervision: Brown, Ten Have, Henriques,Hollander, Beck.Financial Disclosures: None reported.Funding/Support: This research was supported bygrants R01 MH60915 and P20 MH71905 from theNational Institute of Mental Health and grant R37CCR316866 from the Centers for Disease Control andPrevention.Role of the Sponsor: The funding agencies had no rolein the design and conduct of the study; collection,man-agement, analysis, and interpretation of the data; andpreparation, review, or approval of the manuscript.Acknowledgment:We thank the following individu-als who served as study therapists and who receivedcompensation by the funding sponsors: Michele Berk,PhD, Randy Fingerhut, PhD, Evan Forman, PhD,GreggR. Henriques, PhD, Julie Jacobs, PhD, Kenneth Laid-law, PhD, Christine Ratto, PhD, Paula Young, PhD,Debbie Warman, PhD, and Joseph Wright, PhD. Wealso thank the following individualswho served as studycasemanagers andwho received compensation by thefunding sponsors: SarahCharlesworth, BS, JohnGuerry,BA, Jessie Handelsman, BA, Pamela Henderson, RN,Bambi Juryea, BS, Rachel King, BA, Nathaniel Herr, BS,Joseph Moldover, PsyD, Carly Romeo, BA, DaniellaSosdjan,MSW, Lisa Starr, BA, and Sarah Tarquini,MS.We offer special thanks to Frank Sites, RN, for facili-tation of participant recruitment andMark Carey, PhD,for statistical consultation.

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