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Immunological effects of behavioral activation with exercise in major depression: an exploratory randomized controlled trial.

ABSTRACT: Major depression (MD) is associated with peripheral inflammation and increased cardiovascular risk. Regular physical exercise can have anti-inflammatory effects. The present study examined whether behavioral activation with exercise affects inflammatory processes in MD. Ninety-eight patients with MD were randomly assigned to cognitive-behavioral therapy (CBT) emphasizing exercise during behavioral activation (CBT-E), CBT with pleasurable low-energy activities as an active control condition (CBT-C) or a passive waiting list control group (WL). Plasma levels of C-reactive protein (CRP), interleukin (IL)-6, IL-10, lipopolysaccharide (LPS)-stimulated IL-6 production, and blood immune cell counts were analyzed at baseline and weeks 8 (post-behavioral activation) and 16 (post-treatment). Thirty non-depressed age- and sex-matched controls were included to examine potential immunological alterations in MD at baseline. Patients with MD exhibited higher levels of CRP, higher neutrophil and monocyte counts, lower IL-10 levels and reduced LPS-stimulated IL-6 production compared to controls (P<0.001-0.045). Multilevel modeling indicated that CBT-E was associated with increased anti-inflammatory IL-10 at weeks 8 and 16 compared to CBT-C and WL (P=0.004-0.018). CBT-E did not significantly affect other immunological makers in the total sample. A subgroup analysis including patients with potentially higher cardiovascular risk (CRP ?1??g?ml-1) indicated that CRP was reduced in CBT-E compared to CBT-C (P<0.007) and marginally reduced compared to WL (P<0.085) after week 16. The present findings provide new insights into immunological effects of behavioral treatments against depression. Behavioral activation in conjunction with exercise may have the potential to reverse, in part, immunological alterations in MD.

SUBMITTER: Euteneuer F

PROVIDER: S-EPMC5534946 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Immunological effects of behavioral activation with exercise in major depression: an exploratory randomized controlled trial.

Euteneuer F F Dannehl K K Del Rey A A Engler H H Schedlowski M M Rief W W

Translational psychiatry 20170516 5

Major depression (MD) is associated with peripheral inflammation and increased cardiovascular risk. Regular physical exercise can have anti-inflammatory effects. The present study examined whether behavioral activation with exercise affects inflammatory processes in MD. Ninety-eight patients with MD were randomly assigned to cognitive-behavioral therapy (CBT) emphasizing exercise during behavioral activation (CBT-E), CBT with pleasurable low-energy activities as an active control condition (CBT- ...[more]

PMID: 28509904

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Project description:BackgroundWeb-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).ObjectiveThe aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.MethodsWe assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.ResultsWhile groups did not differ regarding the change in depression from t0 to t1 (ηp2=.007, P=.746) or t0 to t2 (ηp2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (ηp2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (ηp2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.ConclusionsAlthough we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registrationDKRS (#DRKS00011562).

Project description:A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood.The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program.This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity.A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former completed more behavioral activation tasks, engaged in different types of activities, and also filled in more cognitive restructuring worksheets than the latter. Activities such as "test-drive a new car," "go to a coffee shop after lunch," or "call up an old friend" were found to be particularly rewarding. All cognitive restructuring strategies were found to significantly decrease the distress level, with "What would be your advice to a friend who has a similar problem?" found more helpful than some other strategies.The CBT program offered via smartphone and connected to the remote server is not only effective in alleviating depression but also opens a new avenue in gathering information of what and how each participant may utilize the program. The activities and strategies found useful in this analysis will provide valuable information in brush-ups of the program itself and of mobile health (mHealth) in general.Japanese 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:BackgroundMajor depressive disorder (MDD) is a global crisis with increasing incidence and prevalence. There are many established evidence-based psychotherapies (EBPs) for depression, but numerous barriers still exist; most notably, access and dissemination. Virtual reality (VR) may offer some solutions to existing constraints of EBPs for MDD.ObjectiveWe aimed to examine the feasibility, acceptability, and tolerability of using VR as a method of delivering behavioral activation (BA) for adults diagnosed with MDD during a global pandemic and to explore for signs of clinical efficacy by comparing VR-enhanced BA (VR BA) to a standard BA treatment and a treatment as usual control group for individuals diagnosed with MDD.MethodsA feasibility trial using a 3-armed, unblinded, randomized controlled pilot design was conducted. The study took place remotely via Zoom telehealth visits between April 8, 2020, and January 15, 2021. This study used a 3-week, 4-session protocol in which VR BA participants used a VR headset to complete their BA homework. Feasibility was measured using dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, the Simulator Sickness Questionnaire, the Brief Agitation Measure, and an adapted Technology Acceptance Model. Efficacy was assessed using the Patient Health Questionnaire-9.ResultsOf the 35 participants assessed for eligibility, 13 (37%) were randomized into VR BA (n=5, 38%), traditional BA (n=4, 31%), or a treatment as usual control (n=4, 31%). The mean age of the 13 participants (5/13, 38% male; 7/13, 54% female; and 1/13, 8% nonbinary or third gender) was 35.4 (SD 12.3) years. This study demonstrated VR BA feasibility in participants with MDD through documented high levels of acceptability and tolerability while engaging in VR-induced pleasurable activities in conjunction with a brief BA protocol. No adverse events were reported. This study also illustrated that VR BA may have potential clinical utility for treating MDD, as the average VR BA participant's clinical severity decreased by 5.67 points, signifying a clinically meaningful change in severity from a moderate to a mild level of depression as per the Patient Health Questionnaire-9 score.ConclusionsThe findings of this study demonstrate that VR BA is safe and feasible to explore for the treatment of MDD. This study documented evidence that VR BA may be efficacious and justifies further examination in an adequately powered randomized controlled trial. This pilot study highlights the potential utility that VR technology may offer patients with MDD, especially those who have difficulty accessing real-world pleasant activities. In addition, for those having difficulty accessing care, VR BA could be adapted as a first step to help people improve their mood and increase their motivation while waiting to connect with a health care professional for other EBPs.Trial registrationClinicalTrials.gov NCT04268316; https://clinicaltrials.gov/ct2/show/NCT04268316.International registered report identifier (irrid)RR2-10.2196/24331.

Project description:BackgroundMeta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem.ObjectiveThis study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications.MethodsA 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures.ResultsWe randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009.ConclusionsAlthough our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

Project description:BackgroundThough behavioral activation (BA) has been shown to be effective for depression, evidence in patients with advanced cancer has not been established. This study aimed to examine the effectiveness of a BA program on depression in this population.MethodsA randomized controlled trial with a wait-list control group (waiting group) of 38 patients with advanced cancer and depression will be conducted at three sites in Japan. The BA program consists of seven sessions. Outcome measures will be evaluated at three times in the intervention group; at the entry, at the end of the intervention and 4 months after the end of the intervention and four times in the waiting group: at the entry, before the intervention, at the end of the intervention, and 4 months after the end of the intervention. Primary outcome is Beck Depression Inventory-II (BDI-II) score. To examine the main effect of the intervention, two-way repeated measures analysis of variance (ANOVA) will be conducted, with timing and intervention status as the independent variables and BDI-II score as the dependent variable. One-way repeated measures ANOVA will be conducted to combine data from the intervention and control groups and examine changes in BDI-II scores by timing in both groups. Secondary endpoints (anxiety, quality of life, spirituality, degree of behavioral activation, value, and pain) will be evaluated with rating scales. Two-way repeated measures ANOVA will be conducted to examine whether there are differences between the groups before and after the intervention, with timing and intervention status as the independent variables and scores on each rating scale as the dependent variables.DiscussionThis multicenter randomized controlled trial is the first study to assess the effectiveness of BA on depression in patients with advanced cancer. Our findings will provide evidence about the effectiveness of BA on depression and provide an intervention option that is acceptable and feasible for the treatment of depression in this population. The results of this study will lead to improved mood and rebuilding to regain life purpose and value in this vulnerable population.Trial registration numberjRCT, jRCT1030210687, Registered 22 March 2022, https://jrct.niph.go.jp/en-latest-detail/jRCT1030210687 .

Dataset Information

Immunological effects of behavioral activation with exercise in major depression: an exploratory randomized controlled trial.

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Immunological effects of behavioral activation with exercise in major depression: an exploratory randomized controlled trial.

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