Mediators of change in online mindfulness-based cognitive therapy: A secondary analysis of a randomized trial of mindful mood balance.

OBJECTIVE: Digital delivery of mindfulness-based cognitive therapy through the Mindful Mood Balance (MMB) program is clinically effective (Segal et al., 2020); however, the mechanisms through which this program delivers its benefits have not been established. METHOD: This study investigates the differential impact of the MMB program paired with usual depression care (UDC) compared to UDC alone on the putative targets of self-reported mindfulness, decentering, and rumination and the extent to which change in these targets mediates subsequent depressive relapse among a sample of predominantly White, female participants, with residual depressive symptoms. RESULTS: The MMB program relative to UDC was associated with a significantly greater rate of change in decentering (t = 4.94, p < .0001, d = 0.46), mindfulness (t = 6.04, p < .0001, d = 0.56), and rumination (t = 3.82, p < .0001, d = 0.36). Subsequent depressive relapse also was mediated by prior change in these putative targets, with a significant natural indirect effect for decentering, χ2(1) = 7.25, p < .008, OR = 0.57; mindfulness, χ2(1) = 9.99, p < .002, OR = 0.50; and rumination, χ2(1) = 12.95, p < .001, OR = 0.35. CONCLUSIONS: These findings suggest the mechanisms of MMB are consistent with the conceptual model for mindfulness-based cognitive therapy and depressive relapse risk and that such processes can be modified through digital delivery. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Impact of online Mindfulness-Based Cognitive Therapy on suicidal ideation: A secondary analysis of a randomized trial of Mindful Mood Balance.

BACKGROUND: To address the elevated prevalence of depression, suicide, and suicidal ideation, patients require increased access to effective interventions. Mindfulness-Based Cognitive Therapy has a strong evidence base in relapse prophylaxis and can be delivered digitally through Mindful Mood Balance (MMB). METHODS: This study was a secondary analysis of the impact of MMB paired with usual depression care (UDC) compared to UDC alone on patients in a randomized clinical trial for residual depression (Segal et al., 2020) who had a history of attempted suicide or reported current suicidal ideation (N = 109). RESULTS: MMB relative to UDC was associated with a greater rate of reduction in suicidal ideation (SI; t(103) = 2.50, p = 0.014, d = 0.49, 95% CI [0.09-0.88]) and a greater likelihood of being in a lower severity category of SI (t(103) = 2.02, p = 0.046, odds ratio = 3.43, 95% CI [1.02-11.53]). There was also evidence that MMB reduces depression severity outcomes among this at risk group (t(105) = 2.38, p < 0.02, d = 0.46, 95% CI [0.07-0.85]). LIMITATIONS: Reported findings are based on a subgroup of patients in a clinical trial originally designed to treat residual depressive symptoms. CONCLUSIONS: Online interventions, such as MMB, may offer one solution to the challenge of expanding the reach of services for patients with residual depression who are at risk of suicidal ideation and behavior.

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

Importance: Patients 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 Participants: This 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 ≥15); 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: ß [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, -33.60 [154.14] 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. Trial Registration: ClinicalTrials.gov identifier: NCT02190968.

Psychotherapies for Panic Disorder: A Tale of Two Sites.

OBJECTIVE: To compare cognitive-behavioral therapy (CBT), panic-focused psychodynamic psychotherapy (PFPP), and applied relaxation training (ART) for primary DSM-IV panic disorder with and without agoraphobia in a 2-site randomized controlled trial. METHOD: 201 patients were stratified for site and DSM-IV agoraphobia and depression and were randomized to CBT, PFPP, or ART (19-24 sessions) over 12 weeks in a 2:2:1 ratio at Weill Cornell Medical College (New York, New York) and University of Pennsylvania ("Penn"; Philadelphia, Pennsylvania). Any medication was held constant. RESULTS: Attrition rates were ART, 41%; CBT, 25%; and PFPP, 22%. The most symptomatic patients were more likely to drop out of ART than CBT or PFPP (P = .013). Outcome analyses revealed site-by-treatment interactions in speed of Panic Disorder Severity Scale (PDSS) change over time (P = .013). At Cornell, no differences emerged on improvement on the primary outcome, estimated speed of change over time on the PDSS; at Penn, ART (P = .025) and CBT (P = .009) showed greater improvement at treatment termination than PFPP. A site-by-treatment interaction (P = .016) for a priori-defined response (40% PDSS reduction) showed significant differences at Cornell: ART 30%, CBT 65%, PFPP 71% (P = .007), but not at Penn: ART 63%, CBT 60%, PFPP 48% (P = .37). Penn patients were more symptomatic, differed demographically from Cornell patients, had a 7.2-fold greater likelihood of taking medication, and had a 28-fold greater likelihood of taking benzodiazepines. However, these differences did not explain site-by-treatment interactions. CONCLUSIONS: All treatments substantially improved panic disorder with or without agoraphobia, but patients, particularly the most severely ill, found ART less acceptable. CBT showed the most consistent performance across sites; however, the results for PFPP showed the promise of psychodynamic psychotherapy for this disorder. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00353470.

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.

OBJECTIVE: Clinical decision-making regarding the prevention of depression is complex for pregnant women with histories of depression and their health care providers. Pregnant women with histories of depression report preference for nonpharmacological care, but few evidence-based options exist. Mindfulness-based cognitive therapy has strong evidence in the prevention of depressive relapse/recurrence among general populations and indications of promise as adapted for perinatal depression (MBCT-PD). With a pilot randomized clinical trial, our aim was to evaluate treatment acceptability and efficacy of MBCT-PD relative to treatment as usual (TAU). METHOD: Pregnant adult women with depression histories were recruited from obstetric clinics at 2 sites and randomized to MBCT-PD (N = 43) or TAU (N = 43). Treatment acceptability was measured by assessing completion of sessions, at-home practice, and satisfaction. Clinical outcomes were interview-based depression relapse/recurrence status and self-reported depressive symptoms through 6 months postpartum. RESULTS: Consistent with predictions, MBCT-PD for at-risk pregnant women was acceptable based on rates of completion of sessions and at-home practice assignments, and satisfaction with services was significantly higher for MBCT-PD than TAU. Moreover, at-risk women randomly assigned to MBCT-PD reported significantly improved depressive outcomes compared with participants receiving TAU, including significantly lower rates of depressive relapse/recurrence and lower depressive symptom severity during the course of the study. CONCLUSIONS: MBCT-PD is an acceptable and clinically beneficial program for pregnant women with histories of depression; teaching the skills and practices of mindfulness meditation and cognitive-behavioral therapy during pregnancy may help to reduce the risk of depression during an important transition in many women's lives.

An open trial of mindfulness-based cognitive therapy for the prevention of perinatal depressive relapse/recurrence.

Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at-risk pregnant women to prevent depression. We examined the feasibility, acceptability, and clinical outcomes of depression symptom severity and relapse/recurrence associated with MBCT adapted for perinatal women (MBCT-PD). Pregnant women with depression histories were recruited from obstetrics clinics in a large health maintenance organization at two sites and enrolled in MBCT-PD (N = 49). Self-reported depressive symptoms and interview-based assessments of depression relapse/recurrence status were measured at baseline, during MBCT-PD, and through 6-months postpartum. Pregnant women reported interest, engagement, and satisfaction with the program. Retention rates were high, as were rates of completion of daily homework practices. Intent to treat analyses indicated a significant improvement in depression symptom levels and an 18 % rate of relapse/recurrence through 6 months postpartum. MBCT-PD shows promise as an acceptable, feasible, and clinically beneficial brief psychosocial prevention option for pregnant women with histories of depression. Randomized controlled trials are needed to examine the efficacy of MBCT-PD for the prevention of depressive relapse/recurrence during pregnancy and postpartum.

Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls.

Mindfulness-based Cognitive Therapy (MBCT) has been shown to effectively prevent relapse and reduce residual depressive symptoms (RDS), yet it faces barriers to dissemination. The present study examined Mindful Mood Balance (MMB), the first web-based approach to deliver the core content of MBCT. Of the 107 recurrently depressed individuals screened, 100 elected to enroll in the study and received MMB in an 8-session open trial with 6-month follow-up. Outcomes included depressive symptom severity, rumination and mindful awareness, and program engagement. A quasi-experimental comparison between MMB participants and propensity matched case-controls receiving usual depression care (UDC) (N = 100) also was conducted. The full sample and the subgroup with residual depressive symptoms (N = 42) showed significantly reduced depressive severity, which was sustained over six months, and improvement on rumination and mindfulness. Examination of acceptability of MMB indicated that 42% of participants within the full sample and 36% of the RDS subgroup completed all 8 sessions and 53% within the full sample and 50% within the RDS subgroup completed at least 4 sessions, and that participants engaged with daily mindfulness practice. MMB also was associated with significant reduction in RDS severity as compared to quasi-experimental propensity matched controls. Although the use of a non-randomized design, with potential unmeasured differences between groups, and short interval of clinical follow-up were limitations, findings from this study support the web-based delivery of MBCT and suggest clinical benefits for participants with histories of depression and with RDS, relative to those receiving usual care alone.

Additional treatment services in a cocaine treatment study: level of services obtained and impact on outcome.

The objective of this study was to examine the level of additional treatment services obtained by patients enrolled in the NIDA Cocaine Collaborative Study, a multi-center efficacy trial of four treatments for cocaine dependence, and to determine whether these services impact treatment outcome. Cocaine-dependent patients (N = 487) were recruited at five sites and randomly assigned to six months of one of four psychosocial treatments. Assessments were made at baseline, monthly during treatment, and at follow-ups at 9, 12, 15, and 18 months post-randomization. On average, patients received little or no additional treatment services during active treatment (first six months), but the rate of obtaining most services increased during the follow-up phase (month 7 to 18). In general, the treatment groups did not differ in the rates of obtaining non-protocol services. For all treatment groups, patients with greater psychiatric severity received more medical and psychiatric services during active treatment and follow-up. Use of treatment services was unrelated to drug use outcomes during active treatment. However, during the follow-up period, increased use of psychiatric medication, twelve-step attendance, and twelve-step participation was related to less drug use. The results suggest that during uncontrolled follow-up phases, additional non-protocol services may potentially confound the interpretation of treatment group comparisons in drug use outcomes.

Six-month treatment outcomes of cocaine-dependent patients with and without PTSD in a multisite national trial.

OBJECTIVE: This study examined 6-month treatment outcomes among 428 cocaine-dependent outpatients with (n = 34) and without (n = 394) posttraumatic stress disorder (PTSD) in a randomized controlled multisite clinical trial of manual-based psychotherapies for substance use disorder (SUD). METHOD: Assessments were completed at baseline and monthly during the 6-month treatment. With longitudinal mixed-effects models, we compared outcomes between SUD-PTSD and SUD-only patients and also examined rates of within-group change. RESULTS: Results indicated a highly consistent pattern: the SUD-PTSD patients were more impaired to begin with and remained so across time compared with SUD-only patients (with the exception of substance use and addiction-related legal and employment problems, which did not differ between groups). Also, the SUD-PTSD patients improved less than SUD-only patients in alcohol use and the majority of addiction-related psychosocial problems. However, the two groups did not differ significantly in improvement over time on drug use or global psychological severity. CONCLUSIONS: The greater impairment and relative lack of improvement of SUD-PTSD patients, compared with those with SUD-only, suggest a need for dual-diagnosis treatments that more directly target their areas of difficulty.

The Women's Recovery Group Study: a Stage I trial of women-focused group therapy for substance use disorders versus mixed-gender group drug counseling.

The aim of this Stage I Behavioral Development Trial was to develop a manual-based 12-session Women's Recovery Group (WRG) and to pilot test this new treatment in a randomized controlled trial against a mixed-gender Group Drug Counseling (GDC), an effective manual-based treatment for substance use disorders. After initial manual development, two pre-pilot groups of WRG were conducted to determine feasibility and initial acceptability of the treatment among subjects and therapists. In the pilot stage, women were randomized to either WRG or GDC. No significant differences in substance use outcomes were found between WRG and GDC during the 12-week group treatment. However, during the 6-month post-treatment follow-up, WRG members demonstrated a pattern of continued reductions in substance use while GDC women did not. In addition, pilot WRG women with alcohol dependence had significantly greater reductions in average drinks/drinking day than GDC women 6 months post-treatment (p<.03, effect size=0.81). While satisfaction with both groups was high, women were significantly more satisfied with WRG than GDC (p<.009, effect size=1.11). In this study, the newly developed 12-session women-focused WRG was feasible with high satisfaction among participants. It was equally effective as mixed-gender GDC in reducing substance use during the 12-week in-treatment phase, but demonstrated significantly greater improvement in reductions in drug and alcohol use over the post-treatment follow-up phase compared with GDC. A women-focused single-gender group treatment may enhance longer-term clinical outcomes among women with substance use disorders.

The effectiveness of St. John's Wort in major depressive disorder: a naturalistic phase 2 follow-up in which nonresponders were provided alternate medication.

BACKGROUND: A continuation study of an extract of St. John's wort (Hypericum perforatum) for depression was performed in follow-up to an acute study that found no significant difference between St. John's wort extract and placebo. METHOD: Seventeen subjects with DSM-IV-defined major depressive disorder who responded to St. John's wort extract in the acute-phase study (phase 1) were continued on double-blind treatment with the same preparation for 24 weeks. Ninety-five subjects who did not respond to either St. John's wort or placebo were treated with an antidepressant for 24 weeks. RESULTS: During antidepressant treatment, mean scores on the Hamilton Rating Scale for Depression for phase 1 nonresponders decreased significantly (p <.0001), with no significant difference between St. John's wort nonresponders and placebo nonresponders. Of the 17 subjects continued on treatment with St. John's wort extract, 5 (29.4%) relapsed. CONCLUSIONS: The subjects who did not respond to St. John's wort extract or placebo in phase 1 were, by and large, not resistant to antidepressant treatment. This suggests that the lack of efficacy found by Shelton et al. in the acute-phase study was unlikely to be the result of a high proportion of treatment-resistant subjects.

Response to tryptophan depletion in major depression treated with either cognitive therapy or selective serotonin reuptake inhibitor antidepressants.

BACKGROUND: Mood sensitivity to rapid tryptophan depletion (RTD) has been demonstrated in patients treated with antidepressants that act preferentially on the serotonergic system. Depressed patients treated with bright-light therapy also show sensitivity to RTD, but those treated with electroconvulsive therapy or total sleep deprivation do not. Patients treated with an empirically supported psychotherapy have not been investigated for sensitivity to tryptophan depletion. This study compares the effects of RTD in patients treated with either selective serotonin re-uptake inhibitors (SSRIs) or cognitive therapy (CT). METHODS: Twenty patients treated with either SSRIs or CT underwent both rapid tryptophan depletion and sham-depletion using a blinded crossover design. Depressive symptoms were assessed using a modified Hamilton Depression Rating Scale (HDRS) and the Beck Depression Inventory (BDI). The differential change in depression scores across procedures between the groups was compared, and effect sizes were calculated. RESULTS: The differential worsening of mood for the SSRI group compared with the CT group was significant on the BDI. The effect size of the differential change was 1.6 for the BDI and.8 for the HDRS. Furthermore, the SSRI group experienced significant mood worsening during depletion compared with sham on both the HDRS and the BDI, whereas the CT group did not. CONCLUSIONS: The CT group was resistant to the effects of tryptophan depletion, but the SSRI group was not.