Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.

INTRODUCTION: There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established. OBJECTIVE: To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT). METHODS: A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment. RESULTS: In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient. CONCLUSIONS: A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.

Improving the Efficiency of Psychotherapy for Depression: Computer-Assisted Versus Standard CBT.

OBJECTIVE: The authors evaluated the efficacy and durability of a therapist-supported method for computer-assisted cognitive-behavioral therapy (CCBT) in comparison to standard cognitive-behavioral therapy (CBT). METHOD: A total of 154 medication-free patients with major depressive disorder seeking treatment at two university clinics were randomly assigned to either 16 weeks of standard CBT (up to 20 sessions of 50 minutes each) or CCBT using the "Good Days Ahead" program. The amount of therapist time in CCBT was planned to be about one-third that in CBT. Outcomes were assessed by independent raters and self-report at baseline, at weeks 8 and 16, and at posttreatment months 3 and 6. The primary test of efficacy was noninferiority on the Hamilton Depression Rating Scale at week 16. RESULTS: Approximately 80% of the participants completed the 16-week protocol (79% in the CBT group and 82% in the CCBT group). CCBT met a priori criteria for noninferiority to conventional CBT at week 16. The groups did not differ significantly on any measure of psychopathology. Remission rates were similar for the two groups (intent-to-treat rates, 41.6% for the CBT group and 42.9% for the CCBT group). Both groups maintained improvements throughout the follow-up. CONCLUSIONS: The study findings indicate that a method of CCBT that blends Internet-delivered skill-building modules with about 5 hours of therapeutic contact was noninferior to a conventional course of CBT that provided over 8 additional hours of therapist contact. Future studies should focus on dissemination and optimizing therapist support methods to maximize the public health significance of CCBT.

The Process of Change in Ethnic Minority Males Undergoing Psychodynamic Psychotherapy: A detailed comparison of two cases.

OBJECTIVE: Better understanding of the connection between therapeutic processes and outcomes in minority groups can help design and use culturally-adapted treatments. METHOD: To explore the active ingredient in the therapeutic process, the present case study compared two ethnic minority male clients, recruited as part of a randomized controlled trial (RCT), one with a good outcome, the other with a poor one. The 12-item Working Alliance Inventory-Observer (S-WAI-O) coding system was used to capture the process of change, alongside a qualitative analysis of content. The cases were identified based on their change in pre- to post-treatment scores on the Beck Depression Inventory (BDI) and the Hamilton Rating Scale for Depression (HRSD). RESULTS: The findings suggest a rupture-resolution process in the good outcome case, including a process of negotiation of the alliance and work on issues of trust. In contrast, the poor outcome case showed strong and steady alliance, but context analysis pointed to withdrawal ruptures. CONCLUSIONS: Although it is difficult to generalize from a two-case study analysis, the present work suggests that building and negotiating alliance with minority clients has a potential for treatment success.

Psychometric Properties of the Reconstructed Hamilton Depression and Anxiety Scales.

Although widely used, the Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS) discriminate poorly between depression and anxiety. To address this problem, Riskind, Beck, Brown, and Steer (J Nerv Ment Dis. 175:474-479, 1987) created the Reconstructed Hamilton Scales by reconfiguring HRSD and HARS items into modified scales. To further analyze the reconstructed scales, we examined their factor structure and criterion-related validity in a sample of patients with major depressive disorder and no comorbid anxiety disorders (n = 215) or with panic disorder and no comorbid mood disorders (n = 149). Factor analysis results were largely consistent with those of Riskind et al. The correlation between the new reconstructed scales was small. Compared with the original scales, the new reconstructed scales correlated more strongly with diagnosis in the expected direction. The findings recommend the use of the reconstructed HRSD over the original HRSD but highlight problems with the criterion-related validity of the original and reconstructed HARS.

Deep Brain Stimulation for Alzheimer's Disease: Ethical Challenges for Clinical Research.

Deep brain stimulation (DBS) is an invasive neuromodulation modality that has shown early promise as a novel treatment of Alzheimer's disease (AD). Further clinical research is warranted on the basis of positive results from animal and human studies, as well as the inadequacy of existing treatments in reducing the enormous medical and financial costs of untreated AD. Nevertheless, unique ethical challenges require particular attention to elements of subject enrollment and informed consent. Study protocols should specify robust assessment and regular monitoring of subject decision-making capacity to consent to trial participation. Investigators should also assess for and mitigate therapeutic misconception (the phenomenon whereby a research participant conflates the goals of research with those of clinical treatment) and ensure that all prospective trial participants have adequate post-trial access to treatment and DBS device maintenance. In the following discussion, each issue is summarized and followed by recommendations for proper ethical procedure. We conclude by assimilating relevant ethical considerations into a decision-making algorithm designed to aid future clinical investigators of DBS for AD with the task of ethical subject enrollment.

A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study.

OBJECTIVE: To evaluate feasibility, efficacy, and tolerability of Sudarshan Kriya yoga (SKY) as an adjunctive intervention in patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment. METHODS: Patients with MDD (defined by DSM-IV-TR) who were depressed despite ≥ 8 weeks of antidepressant treatment were randomized to SKY or a waitlist control (delayed yoga) arm for 8 weeks. The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to 2 months. The key secondary efficacy end points were change in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) total scores. Analyses of the intent-to-treat (ITT) and completer sample were performed. The study was conducted at the University of Pennsylvania between October 2014 and December 2015. RESULTS: In the ITT sample (n = 25), the SKY arm (n = 13) showed a greater improvement in HDRS-17 total score compared to waitlist control (n = 12) (-9.77 vs 0.50, P = .0032). SKY also showed greater reduction in BDI total score versus waitlist control (-17.23 vs -1.75, P = .0101). Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist (ITT mean difference: -5.19; 95% CI, -0.93 to -9.34; P = .0097; completer mean difference: -6.23; 95% CI, -1.39 to -11.07; P = .0005). No adverse events were reported. CONCLUSIONS: Results of this randomized, waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02616549.

Dependency and self-criticism in treatments for depression.

Dependency and self-criticism are vulnerability factors for depression. How these personality factors change with treatment for depression and how they relate to symptom change across different types of treatment require further research. In addition, cultural differences that interact with the dependency/self-criticism-depression relation remain underinvestigated. We randomly assigned 149 adults with major depression to receive active medication (MED; n = 50), supportive-expressive therapy (SET; n = 49), or placebo pill (PBO; n = 50). Participants completed the Depressive Experiences Questionnaire (DEQ; Blatt, D'Afflitti, & Quinlan, 1976) before and after treatment and completed the Hamilton Rating Scale for Depression (Hamilton, 1967) throughout the course of treatment. Self-criticism as measured on the DEQ decreased with treatment similarly across conditions. DEQ Dependency decreased in MED but remained unchanged in SET and PBO. Higher initial dependency, but not higher initial self-criticism, predicted poor treatment response across conditions. Greater reduction in self-criticism was associated with greater reduction in depressive symptoms, but the effect was weaker for racial minorities (vs. White). Increase in connectedness, an adaptive form of dependency, was associated with symptom improvement in SET but not MED. Hence, different pathways of change seem to be implicated in the treatment of depression depending on culture and type of intervention. Implications for future research are discussed. (PsycINFO Database Record

Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations.

OBJECTIVE: Premature discontinuation of therapy is a widespread problem that hampers the delivery of mental health treatment. A high degree of variability has been found among rates of premature treatment discontinuation, suggesting that rates may differ depending on potential moderators. In the current study, our aim was to identify demographic and interpersonal variables that moderate the association between treatment assignment and dropout. METHODS: Data from a randomized controlled trial conducted from November 2001 through June 2007 (N = 156) comparing supportive-expressive therapy, antidepressant medication, and placebo for the treatment of depression (based on DSM-IV criteria) were used. Twenty prerandomization variables were chosen based on previous literature. These variables were subjected to exploratory bootstrapped variable selection and included in the logistic regression models if they passed variable selection. RESULTS: Three variables were found to moderate the association between treatment assignment and dropout: age, pretreatment therapeutic alliance expectations, and the presence of vindictive tendencies in interpersonal relationships. When patients were divided into those randomly assigned to their optimal treatment and those assigned to their least optimal treatment, dropout rates in the optimal treatment group (24.4%) were significantly lower than those in the least optimal treatment group (47.4%; P = .03). CONCLUSIONS: Present findings suggest that a patient's age and pretreatment interpersonal characteristics predict the association between common depression treatments and dropout rate. If validated by further studies, these characteristics can assist in reducing dropout through targeted treatment assignment. TRIAL REGISTRATION: Secondary analysis of data from ClinicalTrials.gov identifier: NCT00043550.

Therapist-reported alliance: Is it really a predictor of outcome?

Most of the literature on the alliance-outcome association is based exclusively on differences between patient reports on alliance. Much less is known about the unique contribution of the therapist's report to this association across treatment, that is, the association between therapist-reported alliance and outcome over the course of treatment, after controlling for the patient's contribution. The present study is the first to examine the unique contribution of the therapist-reported alliance to outcome, accounting for reverse causation (symptomatic levels predicting alliance), at several time points in the course of treatment. Of 156 patients randomized to dynamic supportive-expressive psychotherapy, antidepressant medication with clinical management, and placebo with clinical management, 149 were included in the present study. Alliance was assessed from the perspective of both the patient and the therapist. Outcome measures included the patients' self-reported and diagnostician-rated depressive symptoms. Overall, the findings demonstrate that the therapists' contribution to the alliance-outcome association was explained mainly by prior symptomatic levels. However, when a time lag of several sessions was introduced between alliance and symptoms, a positive association emerged between alliance at 1 time point and symptomatic distress assessed several sessions later in the treatment, controlling for previous symptomatic level. The findings were similar whether or not we controlled for the patient's perspective on the alliance. Taken together, the findings attest to the importance of improving therapists' ability to detect deterioration in the alliance.

Interpersonal problems, dependency, and self-criticism in major depressive disorder.

OBJECTIVES: The goal of the present research was the examination of overlap between 2 research traditions on interpersonal personality traits in major depression. We hypothesized that Blatt's (2004) dimensions of depressive experiences around the dimensions of relatedness (i.e., dependency) and self-definition (i.e., self-criticism) are associated with specific interpersonal problems according to the interpersonal circumplex model (Leary, 1957). In addition, we examined correlations of interpersonal characteristics with depression severity. METHOD: Analyses were conducted on 283 patients with major depressive disorder combined from 2 samples. Of the patients, 151 participated in a randomized controlled trial in the United States, and 132 patients were recruited in an inpatient unit in Germany. Patients completed measures of symptomatic distress, interpersonal problems, and depressive experiences. RESULTS: Dependency was associated with more interpersonal problems related to low dominance and high affiliation, while self-criticism was associated with more interpersonal problems related to low affiliation. These associations were independent of depression severity. Self-criticism showed high overlap with cognitive symptoms of depression. CONCLUSION: The findings support the interpersonal nature of Blatt's dimensions of depressive experiences. Self-criticism is associated with being too distant or cold toward others as well as greater depression severity, but is not related to the dimension of dominance.

Extreme nonresponse to acute phase cognitive therapy for depression: an attempt to replicate and extend.

As with other interventions for major depressive disorder (MDD), cognitive therapy (CT) results in treatment failure for about half of all participants. In 2007, Coffman and colleagues in Seattle studied this topic by identifying a group of patients who demonstrated an extremely poor response to CT (i.e., posttreatment BDI score≥31). They called these patients "extreme nonresponders" (ENR) and described the pretreatment characteristics that predicted response status. In the current study, we attempt a replication of the Seattle study with a larger sample of adults with recurrent MDD (N=473) who received a 16-20 session (12-14week) course of CT. The rate of ENR in this large sample was only 6.3% (30/473), compared to 22.2% (10/45) in the Seattle sample. Four pretreatment measures of symptom severity and functioning differed significantly among ENR and non-ENR participants. In each case, higher symptoms or poorer functioning were associated with ENR status. However, the combination of these factors in a regression model did not predict actual ENR status with the high degree of sensitivity or specificity observed in the Seattle study. These findings suggest that extreme nonresponse to CT is not as common as previously described and, although poor outcomes are associated with pretreatment clinical status, it is difficult to predict posttreatment symptom severity with a high degree of accuracy across different research samples.

Computers and psychotherapy: are we out of a job?

Over the past 15 years, technology has increasingly been incorporated into the provision of psychotherapy with studies emerging demonstrating the effectiveness of such models. However, randomized controlled trials remain scant and little is known about the impact of computer technology on the therapeutic alliance. The studies reported in this section are among the first randomized clinical trials of computer-assisted or internet-based therapies. The following commentary provides a brief overview of each paper and highlights the key issues involved.

Computer-assisted cognitive-behavior therapy for depression.

This article reviews the use of computer technology in treating depression as a substitute or adjunct for standard therapy. It discusses advantages and disadvantages of introducing computer technology as a treatment option, problems and barriers to expanded use, the varieties of computer-assisted psychotherapy for major depression, and relevant research. Three specific Internet-based programs are described, assessed and compared: Good Days Ahead, Beating the Blues, and MoodGYM. The authors conclude that these and similar programs are promising. Preliminary outcome studies suggest that these programs produce outcome similar to standard therapy, although methodological shortcomings limit confidence in these findings. Suggestions are offered for practitioners considering the addition of computer assistance to their treatment of depression.

Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder.

BACKGROUND: Major depressive disorder (MDD) is associated with a decrease in quality of life (QOL) and well-being. Therefore, researchers are increasingly complementing traditional symptom measurements with QOL and well-being assessments in order to broaden the evaluation of treatment outcomes. The current prospective study investigated the effectiveness of supportive-expressive therapy (SET), antidepressant medication (MED) and placebo (PBO) in improving QOL and well-being in patients with MDD. METHODS: Data from a randomized controlled trial (trial registration: NCT00043550) comparing SET, MED and PBO for the treatment of depression (N=156) were analyzed. Outcome measures addressed patients' QOL and physical and mental well-being. Changes in outcomes were assessed across and between treatments using linear mixed models. RESULTS: Across treatments, patients showed significant improvement in QOL and mental and physical health measures, as well as a reduction in interpersonal distress and depressive and anxiety symptoms (p≤.002 for all measures). Those changes were not only the products of a decrease in depressive symptoms, but also predicted subsequent reduction in symptoms. No significant differences were found between the three treatment conditions. LIMITATIONS: The limitation is the study's moderate sample size. CONCLUSIONS: Current treatments for depression significantly improve patients' QOL and well-being. No significant differences were found between the three conditions examined in this study. The current study highlights the role of well-being in predicting subsequent symptomatic change.

The ethical boundaries of patient and advocate influence on DSM-5.

: This article discusses the relationship between disease-advocacy groups and the revision process for the Diagnostic and Statistical Manual of Mental Disorders. We discuss three examples in which patient-advocacy groups engaged with the DSM-5 revision process: Autism Speaks' worries about the contraction of the autism diagnostic category, the National Alliance on Mental Illness's support for the inclusion of psychosis risk syndrome, and B4U-ACT's critique of the expansion of pedophilia. After a descriptive examination of the cases, we address two prescriptive questions. First, what is the ethical basis for patient and advocate influence on DSM diagnoses? Second, how should the American Psychiatric Association proceed when this influence comes into conflict with other goals of the revision process? We argue that the social effects of, and values embedded in, psychiatric classification, combined with patient and advocates' experiential knowledge about those aspects of diagnosis, ethically justify advocate influence in relation to those particular matters. However, this advocate influence ought to have limits, which we briefly explore. Our discussion has implications for discussions of disease categories as loci for social movements, for analyses of the expanding range of processes and institutions that advocacy groups target, and for broader questions regarding the aims of the DSM revision process.

Interpersonal problems as predictors of alliance, symptomatic improvement and premature termination in treatment of depression.

BACKGROUND: Previous studies reported inconsistent findings regarding the association of interpersonal problems with therapy outcome. The current study investigates if interpersonal problems predict process and outcome of three different treatments for depression. METHODS: The data originate from a randomized clinical trial comparing supportive-expressive psychotherapy, antidepressant medication and pill-placebo for treatment of depression. Interpersonal problems were used as predictors of alliance, symptomatic improvement and premature termination of treatment. RESULTS: Interpersonal problems related to communion predicted better alliances, but slower symptomatic improvement. Low agency predicted slower symptomatic improvement in supportive-expressive psychotherapy, but not in the medication or placebo condition. Lower interpersonal distress was associated with an increased likelihood to terminate treatment prematurely. LIMITATIONS: The sample size did not allow the detection of small effects within the treatment groups. CONCLUSIONS: Interpersonal problems are influential for the treatment of depression, but parts of their effects depend on the type of treatment.

Interpersonal problems as predictors of therapeutic alliance and symptom improvement in cognitive therapy for depression.

BACKGROUND: The degree to which interpersonal problems of depressed patients improve over the course of cognitive therapy (CT) and relate to the quality of the therapeutic alliance and to symptom improvement, remains unclear. METHODS: We analyzed data of adult outpatients (N=523) with major depressive disorder participating in a clinical trial to determine the factor structure of the Inventory of Interpersonal Problems-Circumplex (IIP-C) and to relate the observed factor scores to the quality of the therapeutic alliance and symptom improvement over the course of CT. Patients received 16-20 sessions protocol (50-60 min each) of individual CT according to the treatment manual by Beck et al. (1979). RESULTS: We found a three-factor structure (interpersonal distress, agency, and communion) of interpersonal problems. Interpersonal distress decreased (d=.90), but interpersonal style did not change substantively during CT (communion d=.03; agency d=.14). High initial agency scores related negatively to the therapeutic alliance (ß=-.12), whereas high initial communion scores related positively to the therapeutic alliance (ß=.15). Elevated pre-treatment interpersonal distress scores were related to both weaker therapeutic alliances (ß=.13) and higher symptom levels throughout treatment (ß=.10). LIMITATIONS: All patients in this study had recurrent MDD and it is therefore uncertain whether the results would generalize to patients with other psychiatric disorders. CONCLUSIONS: This study supports the use of the IIP-C as a comprehensive measure of patients' interpersonal style and interpersonal distress. The IIP-C measured before CT showed some predictive validity with respect to therapeutic alliance measured at the midpoint and therapy outcome. The clinical importance of these findings is discussed.

Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial.

OBJECTIVE: To determine whether supportive-expressive psychotherapy (SET), a form of dynamic psychotherapy, and pharmacotherapy + clinical management (MED) for major depressive disorder (MDD) are more effective than pill-placebo + clinical management (PBO). METHOD: This National Institute of Mental Health (NIMH)-sponsored randomized controlled trial was conducted (from November 2001 through June 2007) at the University of Pennsylvania Medical School. The sample included 156 patients diagnosed with MDD (DSM-IV) and having a 17-item Hamilton Rating Scale for Depression (HRSD(17)) score ≥ 14 for at least 2 consecutive weeks. This was an underserved sample in which 41% were male, 52% were self-designated minorities, and 76% had an annual income under $30,000. Treatment lasted 16 weeks. Medication patients not responsive by week 8 (maximum dose 200 mg/d of sertraline) were switched to venlafaxine (maximum dose 375 mg/d). Nonresponsive placebo patients at week 8 were switched to a different placebo. RESULTS: Patients' depression improved over the 16 weeks (P < .0001), with no between-group differences (P = .95), even among severely (HRSD(17) score ≥ 20) depressed patients (P = .45). Response rates did not differ between groups (P = .73). Gender and minority status moderated outcome (P = .014), with psychotherapy more efficacious for minority men than MED (P = .027, Cohen d = 1.02) and PBO (P = .019, d = 1.09). PBO was more efficacious for white men than MED (P = .03, d = 0.62) and SET (P = .003, d = 1.07). For white women, MED (P = .005, d = 0.77) and SET (P = .033, d = 0.71) were more efficacious than placebo. No differences among treatments were found for minority women. CONCLUSIONS: This trial of urban MDD patients failed to confirm that either active treatment was better than placebo. Minority status and gender had significant and differential effects on outcome that warrant replication in future studies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00043550.

Beliefs about the causes of depression and treatment preferences.

The relation between patients' beliefs about the causes of their depression, treatment preferences, and demographic variables was studied in a sample of 156 patients in a randomized controlled trial for depression (supportive-expressive psychotherapy vs. medication vs. placebo). No gender differences were found in beliefs or preferences. Racial differences were found for causes endorsed, but not preferences. Treatment experience predicted endorsement of characterological and biological causes. Psychotherapy experience predicted preference for medication. Finally, patients preferring psychotherapy endorsed childhood and complex causes more than those preferring medication, but the groups did not differ in other reasons endorsed. Implications of findings are discussed.

Interpersonal problems in eating disorders.

OBJECTIVE: Eating disorders are often chronic in nature and lead to a number of problems among which interpersonal issues are suggested to be central. Although research has shown that individuals with disturbed patterns of eating consistently report problems in social interactions, this study is unique in assessing a range of interpersonal problems among patients with all types of eating disorders before and after intensive hospital-based treatment. METHOD: A total of 208 patients receiving a primary diagnosis of restrictive anorexia nervosa, bulimia nervosa, or anorexia nervosa of the binge/purging-subtype were included in the study. Eating pathology, symptom severity, and interpersonal patterns were examined before and after treatment. RESULTS: Patients with eating disorders exhibited a generally nonassertive, submissive interpersonal style, with anorexic patients of the binge/purging-subtype reporting more difficulties with social inhibition and nonaffiliation. These patterns were found to change over the course of treatment with interpersonal problems at intake predictive of greater binge severity at discharge. Furthermore, issues of dominance and social avoidance predicted outcome for specific subgroups of patients. DISCUSSION: Results underscore the importance of interpersonal problems in eating disorders and suggest that interpersonal patterns remain a focus of treatment and future research.