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Treatment Preference Pharma Vs Psico For Depression
Treatment Preference Pharma Vs Psico For Depression
Shorter communication
a r t i c l e i n f o a b s t r a c t
Article history: Pharmacotherapy and psychotherapy are generally effective treatments for major depressive disorder
Received 16 September 2009 (MDD); however, research suggests that patient preferences may influence outcomes. We examined the
Received in revised form effects of treatment preference on attrition, therapeutic alliance, and change in depressive severity in
1 April 2010
a longitudinal randomized clinical trial comparing pharmacotherapy and psychotherapy. Prior to
Accepted 8 April 2010
randomization, 106 individuals with MDD reported whether they preferred psychotherapy, antide-
pressant medication, or had no preference. A mismatch between preferred and actual treatment was
Keywords:
associated with greater likelihood of attrition, fewer expected visits attended, and a less positive working
Patient preferences
Depression treatment
alliance at session 2. There was a significant indirect effect of preference match on depression outcomes,
Working alliance primarily via effects of attendance. These findings highlight the importance of addressing patient pref-
Attrition erences, particularly in regard to patient engagement, in the treatment of MDD.
Indirect effects Ó 2010 Elsevier Ltd. All rights reserved.
Multiple mediation
Major depressive disorder (MDD) remains a significant public significant relationships (Leykin et al., 2007), or significant effects
health problem worldwide. Clinical research suggests that the use (Kocsis et al., 2009). However, as suggested by TenHave, Coyne,
of pharmacotherapy and psychotherapy, both singly and in Salzer, and Katz (2003), it is possible that preference matching
combination, are efficacious treatments for depression (see Hollon, may not have a robust effect on changes in severity of depression,
Thase, & Markowitz, 2002). However, it is widely recognized that but may have indirect benefits such as enhanced engagement with
the efficacy of treatments for depression in clinical practice is treatment protocols and better therapeutic relationships.
limited by multiple factors, including premature dropout and non- There appears to be some support for this indirect effect. Rela-
adherence (e.g., Keller, Hirschfeld, Demyttenaere, & Baldwin, 2002; tionships between patient predilections for a specific depression
Melfi et al., 1998). The preferences of patients for a given type of treatment and early attrition and engagement in therapy have been
treatment for depression may influence their willingness to start demonstrated (Elkin et al., 1999). Iacoviello et al. (2007) determined
treatment, complete treatment, and engage fully in the course of that lack of congruence between patients’ treatment preference and
treatment (Corrigan & Salzer, 2003; Raue & Schulberg, 2007). actual treatment was associated with decreasing therapeutic alli-
Patient preference has been identified as a predictor of randomized ance over time, but only for those initially preferring psychotherapy
trial recruitment (King et al., 2005) and attrition, with typically over medication. Qualitative data show that those who dropout from
small effects on primary outcomes (Preference Collaborative psychotherapy cite a mismatch with the therapeutic approach as
Review Group, 2008), in randomized trials across clinical domains. a reason for their decision (Wilson & Sperlinger, 2004).
Studies examining patient preference as a predictor of outcome Given the limited and at times equivocal findings, greater clarity
in randomized clinical trials (RCT) for the treatment of depression of the relationship between preference and key clinical outcomes
have provided equivocal evidence regarding the hypothesis that such as dropout, alliance, and clinical improvement is needed.
patient preferences directly affect clinical outcomes, with various Previous studies typically have not examined the relationship
studies reporting no relationship between preference and outcome between preference and multiple direct (i.e., clinical improvement)
(Dobscha, Corson, & Gerrity, 2007), small, inconsistent, non- and indirect (alliance, attendance, dropout) outcomes. A further
limitation of previous studies is a lack of concrete assessment of
* Corresponding author at: University of Colorado at Boulder, UCB 345, Boulder,
preferences. For example, treatment attrition is often equated with
CO 80309-0345, USA. Tel.: þ1 720 273 2715; fax: þ1 303 492 2967. non-preference, but explicit measurement of preference prior to
E-mail address: bethany.kwan@colorado.edu (B.M. Kwan). the initiation of treatment often has not been carried out.
0005-7967/$ e see front matter Ó 2010 Elsevier Ltd. All rights reserved.
doi:10.1016/j.brat.2010.04.003
800 B.M. Kwan et al. / Behaviour Research and Therapy 48 (2010) 799e804
outcomes in the context of a large randomized clinical trial (RCT). Sample means/frequencies (N ¼ 106)
This RCT compared two psychotherapies (behavioral activation Age: M (SD) 38.4 (11.7)
and cognitive therapy) and pharmacotherapy (paroxetine plus
Gender: N (%)
clinical management) in a placebo controlled trial for adults with Female 68 (64.2)
MDD. Specifically, we examined the role of patient preferences in
Race: N (%)
predicting willingness to start treatment, treatment completion,
White 84 (79.2)
development of a positive working alliance, and improvement in Black/African American 4 (3.8)
depressive severity over the course of acute treatment. We Hispanic/Latino(a) 7 (6.6)
further examined whether there were significant indirect effects Other 11 (10.3)
of preference match on changes in depression via attendance and Relationship status: N (%)
early alliance. We hypothesized: 1) compared to those random- Never married 46 (43.4)
ized to their non-preferred treatment, those randomized to their Married 24 (22.6)
Separated/Divorced 24 (22.6)
preferred treatment would be more likely to demonstrate
Living with partner 11 (10.4)
acceptance of the intervention as defined by being more likely to Widowed 1 (.9)
a) start treatment, b) attend more sessions, and c) to complete
Highest education achieved: N (%)
treatment; 2) compared to those randomized to their non- Some high school 2 (1.9)
preferred treatment, those randomized to their preferred treat- High school degree 36 (34.0)
ment would have higher early ratings of alliance with their College degree 50 (47.2)
clinician; and 3) there would be a significant indirect effect of Graduate degree 17 (16.0)
preference match on depression outcomes via attendance and Income level: N (%)
early alliance. <10000 13 (12.3)
10e19999 8 (7.5)
20e29999 18 (17.0)
30e39999 20 (18.9)
Method 40e49999 12 (11.3)
50,000 33 (31.1)
Participants
Refusing randomization
Treatments Twelve of 106 participants (11.3%) refused randomization. Of
those randomized to their non-preferred group, 7 out of 44 (15.9%)
CT was provided in a manner consistent with standard CT for refused randomization. Five out of 36 individuals (13.9%) who
depression, including an integration of behavioral and cognitive expressed no preference refused randomization. No participants
strategies (Beck, Rush, Shaw, & Emery, 1979; Beck, 1995). BA was randomized to their preferred group refused randomization (vs.
provided as an expanded version of the behavioral interventions non-preferred, c2 (N ¼ 70, df ¼ 1) ¼ 4.60, p ¼ .03; See Fig. 1). Among
described by Beck et al. (1979) and consistent with Martell, Addis, those who were mismatched, most (84.1%) did in fact start treat-
and Jacobson (2001). Participants in BA or CT were seen up to 24 ment; however, among those who refused randomization, none
sessions over a 16 week period, with visits largely occurring twice had been matched to their preferred treatment.
a week for the first 8 weeks and once weekly after that point. The Of those randomized to psychotherapy (CT or BA), 2 out of 33
ADM condition followed the clinical management protocol devel- (6.1%) refused randomization. Of those randomized to pharmaco-
oped for the TDCRP, modified for use with an SSRI (Fawcett, Epstein, therapy (Placebo or ADM), 10 out of 73 (13.7%) refused randomi-
Fiester, Elkin, & Autry, 1987). Participants in ADM were seen weekly zation. Those randomized to pharmacotherapy had about 50%
for the first 4 weeks, and then biweekly through 16 weeks (with greater odds of refusing randomization than those randomized to
those in the placebo condition terminating at 8 weeks). All thera- psychotherapy, OR ¼ 1.57, Wald c2(1) ¼ 1.25, p ¼ .26, although this
pists were trained and supervised by experienced study personnel effect was not statistically significant. The effect of preference
(see Dimidjian et al., 2006, for more details). mismatch on refusing randomization appeared about equal for
those randomized to ADM but preferring psychotherapy (16.2%
refused randomization) and those randomized to psychotherapy
Analysis overview but preferring ADM (14.3% refused randomization). Logistic
regression could not be used to test the interaction between
The General Linear Model procedure was used for continuous condition and preference on refusing randomization because of the
outcomes and Binary Logistic Regression for dichotomous “empty” cell e i.e., there were no participants matched to their
outcomes, using contrast codes for the preference variable. preferred treatment who refused randomization.
Individuals matched with their preferred treatment condition
were coded þ1. Those mismatched were coded 1, and those Study completion
who had no preference were coded 0. Polynomial contrasts were Not including individuals randomized to placebo or refusing
specified in the GLM procedure. This allowed us to maximize randomization, 73 participants started psychotherapy or ADM; of
power by utilizing all participants, including those who reported these,18 (24.6%) did not complete the study. Of the 26 randomized to
no preference. The linear contrasts compared means for the their non-preferred group, 12 (46.2%) did not complete the study as
matched vs. the mismatched groups, ignoring the no-preference compared to 5 out of 27 (18.5%) of those expressing no preference,
group, while quadratic contrasts compared means for the no- and 1 out of 20 (5.0%) of those randomized to their preferred group.
preference group to the preference groups. Where cell sizes Participants had significantly higher odds of dropping out of treat-
permit, we examined interactions between experimental condi- ment if they had been randomized to their non-preferred treatment
tion and preference to determine if the effect of preference on group as compared to those randomized to their preferred treat-
the dependent variables varied based on whether a patient ment group, OR ¼ 7.19, Wald c2(n ¼ 73, df ¼ 1) ¼ 6.45, p ¼ .01 (Fig. 1).
received psychotherapy or ADM. Multilevel modeling was used
to examine the direct effect of preference on changes in HRSD
and BDI scores over time.
Indirect effects of preference match on changes in HRSD scores
were estimated using a path analysis in AMOS 17.0, in which
attendance and WAI-total scores were specified as mediators of the
effect of preference match on depression. Two orthogonal contrast
codes for preference match were specified as exogenous variables,
one for the contrast of match vs. mismatch and one for the contrast
of preference vs. no preference. Within-subject intercepts and
slopes for changes in HRSD scores were calculated using individual
regression models, and used as outcome variables. The model
tested included direct paths from the preference codes to alliance
and attendance, and from these mediators to HRSD slopes and
intercepts. Following the recommendations of Preacher and Hayes
(2008) for multiple mediator models, we performed a boot-
strapping analysis, using 1000 samples and bias-corrected confi-
dence intervals. Fig. 1. Failure to start or complete treatment by preference match.
802 B.M. Kwan et al. / Behaviour Research and Therapy 48 (2010) 799e804
Most of those who did not complete the study (77.8%) were in
the ADM condition. The odds of completing the study were about
50 percent lower (OR ¼ .54, Wald c2 ¼ 3.75, p ¼ .05) for those in the
ADM condition compared to the psychotherapy conditions. The
effect of preference match on study completion did not depend on
treatment group (Wald c2 ¼ .22, p ¼ .9). However, the effect of
preference mismatch on study completion appeared slightly lower
for those randomized to ADM but preferring psychotherapy (50.0%
completed) than those randomized to psychotherapy but prefer-
ring ADM (66.7% completed).
Attendance
Among all patients who started treatment, individuals matched
to their preferred group attended 89.1% of expected visits, indi- Fig. 2. Client- and Therapist-rated session 2 WAI scores by preference match.
viduals without a preference attended 84.9% of expected visits, and
mismatched individuals attended 70.4% of expected visits. Those
randomized to their preferred treatment group attended a signifi- between condition, preference and time was also not significant,
cantly greater proportion of expected sessions (M ¼ .89, SD ¼ .12) b ¼ .08, SE ¼ .09, F(1,98) ¼ .77, p ¼ .38, although directionally this
than those randomized to their non-preferred group (M ¼ .70, suggests slightly greater effects of preference match on changes in
SD ¼ .31), partial h2 ¼ .10, F(1,70) ¼ 7.56, p ¼ .007. There were no HRSD scores over time for those in ADM than those in psycho-
differences in the proportion of sessions attended between those in therapy. There was also no significant effect of match vs. mismatch
ADM (M ¼ .80, SD ¼ .26) and those in BA/CT (M ¼ .82, SD ¼ .20), on changes in BDI scores over time, b ¼ 1.07, SE ¼ 1.01, F
partial h2 ¼ .00, F(1, 71) ¼ .08, p ¼ ns. The effect of preference (1,101) ¼ 1.12, p ¼ .29 (effect size ¼ .25, a small effect).
(match vs. mismatch) on session attendance did not depend on Indirect effects of preference match on HRSD scores were tested
treatment group, partial h2 ¼ .01, F(1,67) ¼ .65, p ¼ .42. according to the model illustrated in Fig. 4. Initially, this model was
not a good fit to the data, c2(N ¼ 57, df ¼ 4) ¼ 10.14, p ¼ .038,
CFI ¼ .733, RMSEA ¼ .17 (90% CI: .035, .296). Upon closer inspection
Working alliance
of the covariance matrix, we noted a significant negative correla-
tion between match vs. mismatch and HRSD intercepts. When
At session 2, patient-rated working alliance (total score) was
allowing these variables to covary, the model fit was excellent,
significantly higher among those randomized to their preferred
c2(N ¼ 57, df ¼ 3) ¼ 1.72, p ¼ .632, CFI ¼ 1.00, RMSEA ¼ .00 (90% CI:
treatment condition (M ¼ 5.76, SD ¼ .80) than those randomized to
.000, .18). In both models, there was a significant indirect effect of
their non-preferred treatment (M ¼ 4.96, SD ¼ 1.12), Partial h2 ¼ .10,
match vs. mismatch on HRSD slopes, est ¼ .12 (90% CI: .21, .05),
F(1,54) ¼ 5.86, p ¼ .022 (Fig. 2). The effect of preference match on
p ¼ .003, and 16% of the variance in HRSD slopes was explained
WAI-total scores did not depend on condition, b ¼ .14, SE ¼ .17,
(primarily by attendance). An identical analysis using BDI scores
Partial h2 ¼ .01, F(1,51) ¼ .64, p ¼ ns. There were no significant
produced similar results.
differences in therapist-rated WAI-total scores for patients
randomized to their preferred group (M ¼ 4.68, SD ¼ .64) compared
to those randomized to their non-preferred group (M ¼ 4.38,
Discussion
SD ¼ .87), Partial h2 ¼ .02, F(1,57) ¼ 2.28, p ¼ .26. There were no
effects of condition on the relationship between preference match
This study examined the effects of patient preferences on
and therapist-rated WAI scores, partial h2 ¼ .00, F(1,54) ¼ .14,
a range of outcomes in an RCT of the treatment of major depression.
p ¼ ns.
Results suggest several negative implications of being randomly
There were significant differences between conditions in both
assigned to a non-preferred mode of treatment. Mismatch had an
patient and therapist WAI ratings from session two. Patients in BA/
effect on whether patients started treatment, such that none of
CT rated the working alliance (total score) significantly higher than
those who refused randomization received a preferred treatment.
those in ADM (M ¼ 5.90, SD ¼ .67 and M ¼ 4.88, SD ¼ 1.08,
Similarly, those randomized to a non-preferred treatment were
respectively), partial h2 ¼ .25, F(1,55) ¼ 18.14, p < .001. Similarly,
more likely to dropout of the study and attend fewer expected
BA/CT therapists rated the working alliance more positively than
visits.3 Patients assigned to a non-preferred treatment also repor-
pharmacotherapists (M ¼ 4.79, SD ¼ .70 and M ¼ 4.30, SD ¼ .79,
ted a less positive early therapeutic alliance than those assigned to
respectively), partial h2 ¼ .10, F(1,58) ¼ 6.45, p < .05. Also, on
a preferred treatment. These findings converge with efforts in
average, patient-ratings were .86 (SD ¼ .96) points higher than
collaborative care highlighting the importance of patient prefer-
therapist-ratings, t(52) ¼ 6.56, p < .001.
ences in staying in treatment for depression (Byrne, Regan, &
Livingston, 2006). These results are thus consistent with the
Preference and outcome suggestion that preference matching influences indirect outcomes
(TenHave et al., 2003).
Fig. 3 shows changes in HRSD scores over time by preference We did not find significant direct effects of preference mismatch
match. The direct effect of preference match on change in HRSD on improvement in depression over the course of treatment. This is
over time was not significant, b ¼ .07, SE ¼ .08, F(1,101) ¼ .79, consistent with the findings of Leykin et al. (2007), who also found
p ¼ .38 (effect size ¼ .21, a small effect). A three-way interaction
3
A reviewer noted that there were different numbers of expected visits for those
2
Data on early working alliance was only available for a portion of the sample in psychotherapy vs pharmacotherapy, and our results might have been influenced
(57 out of 73; 78.1% patients and therapists). Due to administrative error, fewer by this discrepancy. However, the differential frequency and number of sessions is
patients and providers completed the WAI in the pharmacotherapy condition (29 likely to be an inherent aspect of each of the treatments and thus cannot be
out of 42; 69.0%) than in the psychotherapy (28 out of 31, or 90.3%). separated from the other components of treatment.
B.M. Kwan et al. / Behaviour Research and Therapy 48 (2010) 799e804 803
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This research was supported by National Institute of Mental 1089e1099.
Health Grants MH55502 (R01), and MH079636 (F31), a predoctoral Kocsis, J. H., Leon, A. C., Markowitz, J. C., Manber, R., Arnow, B., Klein, D. N., et al.
(2009). Patient preference as a moderator of outcome for chronic forms of
fellowship awarded to Bethany Kwan. We wish to acknowledge the major depressive disorder treated with Nefazodone, Cognitive Behavioral
investigator group for the National Institute of Mental Health Grant Analysis System of Psychotherapy, or their combination. Journal of Clinical
MH55502 (R01): Bob Kohlenberg, Karen Schmaling, David Dunner, Psychiatry, 70(3), 354e361.
Leykin, Y., DeRubeis, R. J., Gallop, R., Amsterdam, J. D., Shelton, R. C., & Hollon, S. D.
Keith Dobson, and Steve Hollon, for their willingness to make data (2007). The relation of patients’ treatment preferences to outcome in
for this report available. GlaxoSmithKline provided medications a randomized clinical trial. Behavior Therapy, 38, 209e217.
and pill placebos for the trial. Correspondence concerning this MacKinnon, D. P., Lockwood, C. M., Hoffman, J. M., West, S. G., & Sheets, V. (2002).
A comparison of methods to test mediation and other intervening variable
article should be addressed to Sona Dimidjian, who is at the
effects. Psychological Methods, 7(1), 83e104.
Department of Psychology, University of Colorado, Boulder, CO Martell, C. R., Addis, M. E., & Jacobson, N. S. (2001). Depression in context: Strategies
80309-0345. E-mail: sona.dimidjian@colorado.edu. for guided action. New York: Norton.
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