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Background: Telephone-administered psychotherapy (tCBT) and internet-based treatments (iCBT) may overcome barriers to mental health treatment. TCBT has demonstrated efficacy similar to traditional psychotherapy, however, few studies have compared iCBT to efficacious interventions. This exploratory study examined the noninferiority of iCBT relative to tCBT. We also explored pretreatment moderators of outcome and assessed treatment dropout., Methods: As a secondary exploratory analysis of a 304-participant randomized noninferiority trial, we compared iCBT, the first level of a stepped-care intervention, with tCBT on depression outcome after 5 weeks of treatment (prior to stepping). Multiple linear regression models were fit to examine moderators of 5-week depression. Differences in dropout were examined using Kaplan-Meier survival analysis., Results: After 5 weeks of treatment, both interventions significantly reduced depression severity. The effect size difference between the two interventions was d=0.004 [90% CI=-0 . 19 to 0 . 19]; the CI did not cross the non-inferiority margin. Pretreatment depression was significantly associated with depression at week 5. The relationship between cognitive strategy usefulness and depression at week 5 differed between interventions, controlling for pretreatment depression. There was no significant difference in dropout between interventions., Limitations: Given the stepped-care trial design, iCBT and tCBT could not be compared at the end of treatment or follow-up. Analyses were exploratory and should be interpreted with caution., Conclusions: A large sample, powered for noninferiority, found iCBT no less efficacious than tCBT at reducing depression symptoms after five weeks of treatment., (Copyright © 2020. Published by Elsevier B.V.)

This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT), was noninferior, less costly to deliver, and as acceptable to patients compared to tCBT alone. Adults with a diagnosis of major depressive episode (MDE) were randomized to receive up to 20 weeks of stepped care or tCBT. Stepped care (n = 134) was noninferior to tCBT (n = 136) with an end-of-treatment effect size of d = 0.03 and a 6-month post-treatment effect size of d = -0.07 [90% CI 0.29 to 0.14]. Therapist time in stepped care was 5.26 (SD = 3.08) hours versus 10.16 (SD 4.01) for tCBT (p < 0.0001), with a delivery cost difference of $-364.32 [95% CI $-423.68 to $-304.96]. There was no significant difference in pre-treatment preferences (p = 0.10) or treatment dropout (39 in stepped care; 27 in tCBT; p = 0.14). tCBT patients were significantly more satisfied than stepped care patients with the treatment they received (p < 0.0001). These findings indicate that stepped care was less costly to deliver, but no less effective than tCBT. There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01906476., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Internet-based cognitive behavioral therapy (iCBT) may overcome barriers to mental health care and has proven efficacious. However, this approach currently exists outside the existing mental health care delivery system. Stepped care is a proposed framework for integrating digital mental health (DMH) into health systems by initiating iCBT and "stepping up" care to a more intensive intervention should iCBT prove ineffective. This study explores pre-treatment factors associated with reaching stepping criteria among patients receiving iCBT. This exploratory analysis of a stepped care arm of a larger randomized trial examined participants who were stepped to a more intensive intervention if they did not respond to iCBT. The association of pre-treatment factors on stepping were examined using Kruskal-Wallis and Chi-square tests. One-fifth of the 151 participants met criteria for stepping within the 20-week treatment period. Only pre-treatment depression severity and treatment preference were associated with increased likelihood of stepping ( p = 0.049 and 0.048, respectively). The low number of individuals who stepped provides support for iCBT as an effective, low intensity treatment for depression. The modest association of pre-treatment depression and preference to not receive iCBT may be useful in identifying patients who are less likely to respond.

Background: Cognitive behavioral therapy (CBT) can be delivered efficaciously through various modalities, including telephone (T-CBT) and face-to-face (FtF-CBT). The purpose of this study was to explore predictors of outcome in T-CBT and FtF-CBT for depression., Method: A total of 325 depressed participants were randomized to receive eighteen 45-min sessions of T-CBT or FtF-CBT. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD) and the Patient Health Questionnaire-9 (PHQ-9). Classification and regression tree (CART) analyses were conducted with baseline participant demographics and psychological characteristics predicting depression outcomes, HAMD and PHQ-9, at end of treatment (week 18)., Results: The demographic and psychological characteristics accurately identified 85.3% and 85.0% of treatment responders and 85.7% and 85.0% of treatment non-responders on the HAMD and PHQ-9, respectively. The Coping self-efficacy (CSE) scale predicted outcome on both the HAMD and PHQ-9; those with moderate to high CSE were likely to respond with no other variable influencing that prediction. Among those with low CSE, depression severity influenced response. Social support, physical functioning, and employment emerged as predictors only for the HAMD, and sex predicted response on the PHQ-9. Treatment delivery method (i.e. telephone or face-to-face) did not impact the prediction of outcome., Conclusions: Findings suggest that the predictors of improved depression are similar across treatment modalities. Most importantly, a moderate to high level of CSE significantly increases the chance of responding in both T-CBT and FtF-CBT. Among patients with low CSE, those with lower depressive symptom severity are more likely to do well in treatment.

Objective: Monitoring depressive symptoms during treatment can guide clinical decision making and improve outcomes. The aim of this study was to explore values on the Patient Health Questionnaire (PHQ-9) that could predict response to treatment., Method: Data came from two independent trials, including three treatment modalities of cognitive-behavioral treatment for depression. Four hundred eighty-seven participants who either met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria for major depressive disorder or had PHQ-9 scores consistent with a diagnosis of depression were included in our analyses. Participants either received 18 weeks of telephone or face-to-face (n=279) or 8 weeks of Web-delivered (n=208) cognitive-behavioral therapy. Depressive symptoms, evaluated using the PHQ-9, were reported every 4 weeks in the telephone and face-to-face trial and weekly in the Web-delivered intervention trial., Results: Optimal cut points for predicting end-of-treatment response were consistent in both trials. Our results suggested using cut points of a PHQ-9 ≥17 at Week 4, and PHQ-9 ≥13 at Week 9 and PHQ-9 ≥9 at Week 14., Conclusions: Consistent cut points were found within the included trials. These cut points may be valuable for algorithms to support clinical decision making., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The present study examines the role of comorbid anxiety on depression outcomes for those receiving cognitive behavioral therapy (CBT) for depression by telephone (T-CBT) or face-to-face (FtF-CBT)., Methods: Three hundred twenty-five participants were randomized to T-CBT or FtF-CBT. Comorbid anxiety was measured using the Mini International Neuropsychiatric Interview and Generalized Anxiety Disorder 7. Depression was measured using the Hamilton Rating Scale for Depression and Patient Health Questionnaire 9., Results: A hierarchical model including the two-way interaction of treatment assignment and anxiety status indicated a significant effect for all outcome variables (Ps < .05). Post hoc t tests indicated T-CBT participants with comorbid anxiety disorders had significantly higher symptom severity over time compared to their T-CBT counterparts without anxiety (Ps < .001) and FtF-CBT counterparts with comorbid anxiety (Ps < .003). There were no significant differences in outcomes between those with and without comorbid anxiety disorders receiving FtF-CBT, or between T-CBT and FtF-CBT among those without comorbid anxiety disorders., Conclusions: The findings indicate that the presence of baseline anxiety impacts the overall effect of T-CBT for the treatment of depression., (© 2014 Wiley Periodicals, Inc.)

An objective, laboratory-based diagnostic tool could increase the diagnostic accuracy of major depressive disorders (MDDs), identify factors that characterize patients and promote individualized therapy. The goal of this study was to assess a blood-based biomarker panel, which showed promise in adolescents with MDD, in adult primary care patients with MDD and age-, gender- and race-matched nondepressed (ND) controls. Patients with MDD received cognitive behavioral therapy (CBT) and clinical assessment using self-reported depression with the Patient Health Questionnaire-9 (PHQ-9). The measures, including blood RNA collection, were obtained before and after 18 weeks of CBT. Blood transcript levels of nine markers of ADCY3, DGKA, FAM46A, IGSF4A/CADM1, KIAA1539, MARCKS, PSME1, RAPH1 and TLR7, differed significantly between participants with MDD (N=32) and ND controls (N=32) at baseline (q< 0.05). Abundance of the DGKA, KIAA1539 and RAPH1 transcripts remained significantly different between subjects with MDD and ND controls even after post-CBT remission (defined as PHQ-9 <5). The ROC area under the curve for these transcripts demonstrated high discriminative ability between MDD and ND participants, regardless of their current clinical status. Before CBT, significant co-expression network of specific transcripts existed in MDD subjects who subsequently remitted in response to CBT, but not in those who remained depressed. Thus, blood levels of different transcript panels may identify the depressed from the nondepressed among primary care patients, during a depressive episode or in remission, or follow and predict response to CBT in depressed individuals.

Objective: Telephone-administered therapies have emerged as an alternative method of delivery for the treatment of depression, yet concerns persist that the use of the telephone may have a deleterious effect on therapeutic alliance. The purpose of this study was to compare therapeutic alliance in clients receiving cognitive behavioral therapy (CBT) for depression by telephone (T-CBT) or face-to-face (FtF-CBT)., Method: We randomized 325 participants to receive 18 sessions of T-CBT or FtF-CBT. The Working Alliance Inventory (WAI) was administered at Weeks 4 and 14. Depression was measured during treatment and over 1 year posttreatment follow-up using the Hamilton Rating Scale for Depression and Patient Health Questionnaire-9., Results: There were no significant differences in client or therapist WAI between T-CBT or FtF-CBT (Cohen's f² ranged from 0 to .013, all ps > .05). All WAI scores predicted depression end of treatment outcomes (Cohen's f² ranged from .009 to .06, all ps < .02). The relationship between the WAI and depression outcomes did not vary by treatment group (Cohen's f² ranged from 0 to .004, ps > .07). The WAI did not significantly predict depression during posttreatment follow-up (all ps > .12)., Conclusions: Results from this analysis do not support the hypothesis that the use of the telephone to provide CBT reduces therapeutic alliance relative to FtF-CBT.