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Divergent Outcomes in Cognitive-Behavioral Therapy and Pharmacotherapy for Adult Depression.

ABSTRACT: Although the average depressed patient benefits moderately from cognitive-behavioral therapy (CBT) or pharmacotherapy, some experience divergent outcomes. The authors tested frequencies, predictors, and moderators of negative and unusually positive outcomes.Sixteen randomized clinical trials comparing CBT and pharmacotherapy for unipolar depression in 1,700 patients provided individual pre- and posttreatment scores on the Hamilton Depression Rating Scale (HAM-D) and/or Beck Depression Inventory (BDI). The authors examined demographic and clinical predictors and treatment moderators of any deterioration (increase ?1 HAM-D or BDI point), reliable deterioration (increase ?8 HAM-D or ?9 BDI points), extreme nonresponse (posttreatment HAM-D score ?21 or BDI score ?31), superior improvement (HAM-D or BDI decrease ?95%), and superior response (posttreatment HAM-D or BDI score of 0) using multilevel models.About 5%-7% of patients showed any deterioration, 1% reliable deterioration, 4%-5% extreme nonresponse, 6%-10% superior improvement, and 4%-5% superior response. Superior improvement on the HAM-D only (odds ratio=1.67) and attrition (odds ratio=1.67) were more frequent in pharmacotherapy than in CBT. Patients with deterioration or superior response had lower pretreatment symptom levels, whereas patients with extreme nonresponse or superior improvement had higher levels.Deterioration and extreme nonresponse and, similarly, superior improvement and superior response, both occur infrequently in randomized clinical trials comparing CBT and pharmacotherapy for depression. Pretreatment symptom levels help forecast negative and unusually positive outcomes but do not guide selection of CBT versus pharmacotherapy. Pharmacotherapy may produce clinician-rated superior improvement and attrition more frequently than does CBT.

SUBMITTER: Vittengl JR

PROVIDER: S-EPMC4934129 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Divergent Outcomes in Cognitive-Behavioral Therapy and Pharmacotherapy for Adult Depression.

Vittengl Jeffrey R JR Jarrett Robin B RB Weitz Erica E Hollon Steven D SD Twisk Jos J Cristea Ioana I David Daniel D DeRubeis Robert J RJ Dimidjian Sona S Dunlop Boadie W BW Faramarzi Mahbobeh M Hegerl Ulrich U Kennedy Sidney H SH Kheirkhah Farzan F Mergl Roland R Miranda Jeanne J Mohr David C DC Rush A John AJ Segal Zindel V ZV Siddique Juned J Simons Anne D AD Cuijpers Pim P

The American journal of psychiatry 20160212 5

<h4>Objective</h4>Although the average depressed patient benefits moderately from cognitive-behavioral therapy (CBT) or pharmacotherapy, some experience divergent outcomes. The authors tested frequencies, predictors, and moderators of negative and unusually positive outcomes.<h4>Method</h4>Sixteen randomized clinical trials comparing CBT and pharmacotherapy for unipolar depression in 1,700 patients provided individual pre- and posttreatment scores on the Hamilton Depression Rating Scale (HAM-D) ...[more]

PMID: 26869246

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Project description:BackgroundIn the treatment of major depression, antidepressants are effective but not curative. Cognitive behavioral therapy (CBT) is also effective, alone or in combination with pharmacotherapy, but accessibility is a problem.ObjectiveThe aim is to evaluate the effectiveness of a smartphone CBT app as adjunctive therapy among patients with antidepressant-resistant major depression.MethodsA multisite, assessor-masked, parallel-group randomized controlled trial was conducted in 20 psychiatric clinics and hospitals in Japan. Participants were eligible if they had a primary diagnosis of major depression and were antidepressant-refractory after taking one or more antidepressants at an adequate dosage for four or more weeks. After a 1-week run-in in which participants started the medication switch and had access to the welcome session of the app, patients were randomized to medication switch alone or to medication switch plus smartphone CBT app via the centralized Web system. The smartphone app, called Kokoro-app ("kokoro" means "mind" in Japanese), included sessions on self-monitoring, behavioral activation, and cognitive restructuring presented by cartoon characters. The primary outcome was depression severity as assessed by masked telephone assessors with the Patient Health Questionnaire-9 (PHQ-9) at week 9. The secondary outcomes included the Beck Depression Inventory-II (BDI-II) and Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER).ResultsIn the total sample (N=164), 81 participants were allocated to the smartphone CBT in addition to medication change and 83 to medication change alone. In the former group, all but one participant (80/81, 99%) completed at least half, and 71 (88%) completed at least six of eight sessions. In the intention-to-treat analysis, patients allocated the CBT app scored 2.48 points (95% CI 1.23-3.72, P<.001; standardized mean difference 0.40) lower on PHQ-9 than the control at week 9. The former group also scored 4.1 points (95% CI 1.5-6.6, P=.002) lower on BDI-II and 0.76 points (95% CI -0.05 to 1.58, P=.07) lower on FIBSER. In the per-protocol sample (comfortable with the smartphone app, still symptomatic, and adherent to medication with mild or less side effects after run-in), the intervention group (n=60) scored 1.72 points (95% CI 0.25-3.18, P=.02) lower on PHQ-9, 3.2 points (95% CI -0.01 to 6.3, P=.05) lower on BDI-II, and 0.75 points (95% CI 0.03-1.47, P=.04) lower on FIBSER than the control (n=57). The treatment benefits were maintained up to week 17.ConclusionsThis is the first study to demonstrate the effectiveness of a smartphone CBT in the treatment of clinically diagnosed depression. Given the merits of the mobile mental health intervention, including accessibility, affordability, quality control, and effectiveness, it is clinically worthwhile to consider adjunctive use of a smartphone CBT app when treating patients with antidepressant-resistant depression. Research into its effectiveness in wider clinical contexts is warranted.Trial registrationJapanese Clinical Trials Registry UMIN CTR 000013693; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000015984 (Archived by WebCite at http://www.webcitation.org/6u6pxVwik).

Project description:BackgroundInternet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation.ObjectiveThe primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder.MethodsA 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up.ResultsA total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: β=-.03; standard error [SE] 0.00; P<.001 and B-CBT: β=-.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (β=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group.ConclusionsWith large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months' follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution.Trial registrationClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573.International registered report identifier (irrid)RR2-10.1186/s12888-016-1140-y.

Project description:BackgroundInternet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear.ObjectiveThis study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care.Methodsn a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment.ResultsA total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03).ConclusionsiCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

Project description:BackgroundCurrent psychiatric epidemiological evidence estimates that 17% of young adults (aged 18-25 years) experienced a major depressive episode in 2020, relative to 8.4% of all adults aged ≥26 years. Young adults with a major depressive episode in the past year are the least likely to receive treatment for depression compared with other age groups.ObjectiveWe conducted a randomized clinical trial following our initial 4-week SMS text message-delivered cognitive behavioral therapy (CBT-txt) for depression in young adults. We sought to test mechanisms of change for CBT-txt.MethodsBased on participant feedback, outcome data, and the empirical literature, we increased the treatment dosage from 4-8 weeks and tested 3 mechanisms of change with 103 young adults in the United States. Participants were from 34 states, recruited from Facebook and Instagram and presenting with at least moderate depressive symptomatology. Web-based assessments occurred at baseline prior to randomization and at 1, 2, and 3 months after enrollment. The primary outcome, the severity of depressive symptoms, was assessed using the Beck Depression Inventory II. Behavioral activation, perseverative thinking, and cognitive distortions were measured as mechanisms of change. Participants were randomized to CBT-txt or a waitlist control condition. Those assigned to the CBT-txt intervention condition received 474 fully automated SMS text messages, delivered every other day over a 64-day period and averaging 14.8 (SD 2.4) SMS text messages per treatment day. Intervention texts are delivered via TextIt, a web-based automated SMS text messaging platform.ResultsAcross all 3 months of the study, participants in the CBT-txt group showed significantly larger decreases in depressive symptoms than those in the control group (P<.001 at each follow-up), producing a medium-to-large effect size (Cohen d=0.76). Over half (25/47, 53%) of the treatment group moved into the "high-end functioning" category, representing no or minimal clinically significant depressive symptoms, compared with 15% (8/53) of the control condition. Mediation analysis showed that CBT-txt appeared to lead to greater increases in behavioral activation and greater decreases in cognitive distortions and perseverative thinking across the 3-month follow-up period, which were then associated with larger baseline to 3-month decreases in depression. The size of the indirect effects was substantial: 57%, 41%, and 50% of the CBT-txt effect on changes in depression were mediated by changes in behavioral activation, cognitive distortions, and perseverative thinking, respectively. Models including all 3 mediators simultaneously showed that 63% of the CBT-txt effect was mediated by the combined indirect effects.ConclusionsResults provide evidence for the efficacy of CBT-txt to reduce young adult depressive symptoms through hypothesized mechanisms. To the best of our knowledge, CBT-txt is unique in its SMS text message-delivered modality, the strong clinical evidence supporting efficacy and mechanisms of change.Trial registrationClinicalTrials.gov NCT05551702; https://clinicaltrials.gov/study/NCT05551702.

Dataset Information

Divergent Outcomes in Cognitive-Behavioral Therapy and Pharmacotherapy for Adult Depression.

Publications

Divergent Outcomes in Cognitive-Behavioral Therapy and Pharmacotherapy for Adult Depression.

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