Objective Mindfulness meditation has met increasing interest as a therapeutic strategy for anxiety disorders, but prior studies have been limited by methodological concerns, including a lack of an active comparison group. This is the first randomized, controlled trial comparing the manualized Mindfulness-Based Stress Reduction (MBSR) program with an active control for Generalized Anxiety Disorder, a disorder characterized by chronic worry and physiological hyperarousal symptoms. Method Ninety-three individuals with DSM-IV-diagnosed GAD were randomized to an 8-week group intervention with MBSR or to an attention control, Stress Management Education (SME) between 2009 and 2011. Anxiety symptoms were measured with the Hamilton Anxiety Scale (HAM-A, primary outcome measure), the Clinical Global Impression of Severity and Improvement (CGI-S and CGI-I), and the Beck Anxiety Inventory (BAI). Stress reactivity was assessed by comparing anxiety and distress during pre- and post-treatment Trier Social Stress Tests (TSST). Results A modified intent-to-treat analysis including participants who completed at least one session of MBSR (N=48) or SME (N=41) showed that both interventions led to significant reductions in HAM-A scores at endpoint, but did not significantly differ. MBSR, however, was associated with a significantly greater reduction in anxiety as measured by the CGI-S, the CGI-I, and the BAI (all Ps<0.05). MBSR was also associated with greater reductions than SME in anxiety and distress ratings in response to the TSST stress challenge (P<0.05), and a greater increase in positive self-statements (P=0.004). Conclusions These results suggest that MBSR may have a beneficial effect on anxiety symptoms in GAD, and may also improve stress reactivity and coping as measured in a laboratory stress challenge.

Objective Depression among pregnant women is a prevalent public health problem associated with poor maternal and offspring development. Behavioral Activation (BA) is a scalable intervention aligned with pregnant women’s preference for non-pharmacological depression care. This is the first test of the effectiveness of BA for depression among pregnant women, which aimed to evaluate the effectiveness of BA as compared with treatment as usual (TAU). Method Pregnant women (mean age = 28.75; SD = 5.67) with depression symptoms were randomly assigned to BA (n = 86) or TAU (n = 77). Exclusion criteria included known bipolar or psychotic disorder or immediate self-harm risk. Follow-up assessment occurred 5 and 10 weeks post-randomization and 3 months postpartum using self-report measures of primary and secondary outcomes and putative targets. Results Compared with TAU, BA was associated with significantly lower depressive symptoms (d = 0.34, p = .04) and higher remission (56.3% vs. 30.3%, p = .003). BA also demonstrated significant advantage on anxiety and perceived stress. Participants attended most BA sessions and reported high satisfaction. Participants in BA reported significantly higher levels of behavioral activation (d = 0.69, p <.0002) and environmental reward (d = 0.54, p < .003) than those who received TAU, and early change in both of these putative targets significantly mediated subsequent depression outcomes. Conclusions BA is effective for pregnant women, offering significant depression, anxiety, and stress related benefits, with mediation analyses supporting the importance of putative targets of activation and environmental reward.

No abstract

IMPORTANCEPatients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.OBJECTIVE To evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only. DESIGN, SETTING, AND PARTICIPANTSThis randomized clinical trial was conducted in primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver. Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018. Outcomes were assessed for a 15-month period, comprising a 3-month intervention interval and a 12-month follow-up period.INTERVENTIONS Patients were randomized to receive usual depression care (UDC; n = 230) or MMB plus UDC (n = 230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support.MAIN OUTCOMES AND MEASURES Primary outcomes were reduction in residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores Ն15); and rates of remission (PHQ-9 scores <5). Secondary outcomes included depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey). RESULTS Among 460 randomized participants (mean [SD] age, 48.30 [14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months. Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P < .02). A significantly greater proportion of patients achieved remission in the MMB plus UDC group compared with the UDC only group (PHQ-9 score, <5: β [SE], 0.38 [0.14], P = .008), and rates of depressive relapse were significantly lower in the MMB plus UDC group compared with the UDC only group (hazard ratio, 0.61; 95% CI, 0.39-0.95; P < .03). Compared with the UDC only group, the MMB plus UDC group had decreased depression-free days (mean [SD], 281.14 [164.99] days vs 247.54 [158.32] days; difference, days; t = −2.33; P = .02), decreased anxiety (mean [SE] General Anxiety Disorder-7 Item Scale score, 1.21 [0.42], P = .004), and improved mental functioning (mean [SE] 12-Item Short Form Survey score, −5.10 [1.37], P < .001), but there was no statistically significant difference in physical functioning.CONCLUSIONS AND RELEVANCE Use of MMB plus UDC resulted in significant improvement in depression and functional outcomes compared with UDC only. The MMB web-based treatment may offer a scalable approach for the management of residual depressive symptoms.