Mindfulness-Based Program for Anxiety and Depression Treatment in Healthcare Professionals: A Pilot Randomized Controlled Trial.
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SUBMITTER: Santamaria-Pelaez M
PROVIDER: S-EPMC8708843 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundUniversity students are experiencing higher levels of distress and mental health disorders than before. In addressing mental health needs, web-based interventions have shown increasing promise in overcoming geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web-based program, guided by mindfulness and cognitive behavioral therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students.ObjectiveThis study's aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, this study coincided with a university-wide labor strike. Nonetheless, the students' response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to the COVID-19 pandemic as well as future disruptions.MethodsIn this parallel-arm RCT, 154 students were randomly allocated to an 8-week MVC intervention (n=76) or a wait-list control (WLC) condition (n=78). The MVC intervention included the following: (1) educational and mindfulness video modules, (2) anonymous peer-to-peer discussions, and (3) anonymous, group-based, professionally guided, 20-minute videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using the following: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR (1) covariance structure were used to evaluate the impact of the intervention, with outcome evaluations performed on both an intention-to-treat (ITT) and per-protocol (PP) basis.ResultsParticipants (n=154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the two groups. Results under both ITT and PP approaches indicated that there were no statistically significant between-group differences in PHQ-9 (ITT: β=-0.44, P=.64; PP: β=-0.62, P=.053), BAI (ITT: β=-2.06, P=.31; PP: β=-2.32, P=.27), and FFMQ-SF (ITT: β=1.33, P=.43; PP: β=1.44, P=.41) compared to WLC. There was a significant difference for the PSS (ITT: β=-2.31, P=.03; PP: β=-2.38, P=.03).ConclusionsDuring a university labor strike, the MVC program led to statistically significant reductions in PSS compared to the WLC group, but there were no other significant between-group differences. Comparisons with previous cycles of intervention testing, undertaken during nondisrupted university operations, when efficacy was demonstrated, are discussed.Trial registrationISRCTN Registry ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.
| S-EPMC7833974 | biostudies-literature
Project description:The COVID-19 pandemic has had adverse mental health effects for many groups in British society, especially young adults and university students. The present study reports secondary outcomes (i.e., symptoms of anxiety and depression) from a randomized waitlist controlled trial, with a one-month post-intervention follow-up, on the effects of a guided, eight-week mindfulness program delivered online during the COVID-19 pandemic among students at the University of Oxford. Longitudinal multilevel models showed greater reductions in anxiety but not depression symptoms for participants in the mindfulness condition relative to participants in the waitlist control condition (time X group B=-0.36, p=.025).
| S-EPMC8459547 | biostudies-literature
Project description:BackgroundInterventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs.ObjectiveThis randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program.MethodsParticipants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed.ResultsIn the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice.ConclusionsThe program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance.ClinicaltrialClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).
| S-EPMC4975795 | biostudies-literature
Project description:BackgroundMindfulness and meditation have a rich historical tradition, and a growing scientific base of evidence supports their use in creating positive psychological and neuroplastic changes for practitioners. Although meditation can be taught in various ways, the scientific community has yet to systematically study the impact of different types of meditation on neuropsychological outcomes, especially as it pertains to digital implementation. Therefore, it is critical that the instruction of mindfulness be evidence based because meditation is being used in both scientific and clinical settings.ObjectiveThis study investigated the use of teacher cueing and the integration of neuroscience education into a meditation program. Compassion cueing was chosen as the element of experimental manipulation because traditional lineages of Buddhist meditation teach compassion for self and others as one of the primary outcomes of meditation. We hypothesized that participants receiving compassion cueing would have enhanced neuropsychological outcomes compared with those receiving functional cueing and that gains in neuroscience knowledge would relate to positive neuropsychological outcomes.MethodsParticipants (n=89) were randomized to receive either functional cueing (control group) or compassion cueing (experimental group) and engaged with five 10-minute meditation sessions a week for 4 weeks. All intervention sessions were administered through digital presentation. All participants completed ecological momentary assessments before and after the daily intervention, as well as pre- and postintervention questionnaires.ResultsParticipants demonstrated significant benefits over time, including increased mindfulness and self-compassion, decreased depression, and gains in neuroscience content (all P<.001); however, no significant between-group differences were found. Daily scores from each day of the intervention showed a statistically significant shift from active toward settled. Importantly, long-term increases in mindfulness were positively correlated to changes in compassion (r=0.326; P=.009) and self-compassion (r=0.424; P<.001) and negatively correlated to changes in anxiety (r=-0.266; P=.03) and depression (r=-0.271; P=.03). Finally, the acute effects of meditation were significantly correlated to the longitudinal outcomes (with a small-to-medium effect size), especially those relevant to mindfulness.ConclusionsWe developed a novel neuroscience-based education-meditation program that enhanced self-regulation as evidenced by improved mindfulness, self-compassion, and mood state. Our findings demonstrate the behavioral importance of engaging with mindfulness meditation and reinforce the idea that the benefits of meditation are independent of teacher cueing behavior. Future studies will need to investigate the brain-based changes underlying these meditation-induced outcomes.
| S-EPMC9896358 | biostudies-literature
Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.ObjectiveThis study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.MethodsThis study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.ResultsOf the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.ConclusionsAdolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.Trial registrationClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.
| S-EPMC7414416 | biostudies-literature
Project description:OBJECTIVE:Internet-delivered interventions may alleviate distress in cancer survivors with limited access to psychological face-to-face treatment. In collaboration with a group of cancer survivors, we developed and tested the efficacy of a therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program for anxiety and depression in cancer survivors. METHODS:A total of 1282 cancer survivors were screened for anxiety and depression during their routine oncology follow-up; eligible breast (n = 137) and prostate cancer (n = 13) survivors were randomized to iMBCT or care-as-usual (CAU) wait-list. Primary outcomes of anxiety and depression were assessed at baseline, 5 weeks, 10 weeks (post intervention), and 6 months. RESULTS:Significant effects were found for both anxiety (Cohen's d = 0.45; P = .017) and depressive symptoms (d = 0.42; P = .024) post intervention. The effects were maintained at follow-up for anxiety (d = 0.40; P = .029), but not for depressive symptoms (d = 0.28; P = .131). CONCLUSIONS:Our preliminary findings suggest iMBCT to be a helpful intervention for cancer survivors suffering from symptoms of anxiety. Further studies on the efficacy for symptoms of depression are needed.
| S-EPMC7004073 | biostudies-literature
Project description:BackgroundDepression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.
| S-EPMC8895278 | biostudies-literature
Project description:BackgroundArtificial intelligence-based chatbots are emerging as instruments of psychological intervention; however, no relevant studies have been reported in Latin America.ObjectiveThe objective of the present study was to evaluate the viability, acceptability, and potential impact of using Tess, a chatbot, for examining symptoms of depression and anxiety in university students.MethodsThis was a pilot randomized controlled trial. The experimental condition used Tess for 8 weeks, and the control condition was assigned to a psychoeducation book on depression. Comparisons were conducted using Mann-Whitney U and Wilcoxon tests for depressive symptoms, and independent and paired sample t tests to analyze anxiety symptoms.ResultsThe initial sample consisted of 181 Argentinian college students (158, 87.2% female) aged 18 to 33. Data at week 8 were provided by 39 out of the 99 (39%) participants in the experimental condition and 34 out of the 82 (41%) in the control group. On an average, 472 (SD 249.52) messages were exchanged, with 116 (SD 73.87) of the messages sent from the users in response to Tess. A higher number of messages exchanged with Tess was associated with positive feedback (F2,36=4.37; P=.02). No significant differences between the experimental and control groups were found from the baseline to week 8 for depressive and anxiety symptoms. However, significant intragroup differences demonstrated that the experimental group showed a significant decrease in anxiety symptoms; no such differences were observed for the control group. Further, no significant intragroup differences were found for depressive symptoms.ConclusionsThe students spent a considerable amount of time exchanging messages with Tess and positive feedback was associated with a higher number of messages exchanged. The initial results show promising evidence for the usability and acceptability of Tess in the Argentinian population. Research on chatbots is still in its initial stages and further research is needed.
| S-EPMC8391753 | biostudies-literature
Project description:BackgroundDepression and anxiety affect approximately 50% of patients with kidney failure receiving hemodialysis and are associated with decreased quality of life and increased risk of hospitalization and mortality. A Brief Mindfulness Intervention (BMI) may be promising in treating depressive and anxiety symptoms in this population, but the long-term sustainability of the intervention's effects is unknown.ObjectiveWe previously conducted a randomized controlled trial (RCT; n = 55) comparing an 8-week BMI with an active control (Health Enhancement Program [HEP]) for patients receiving dialysis, with depression and/or anxiety. Here, we examine the 6-month follow-up data to determine the long-term sustainability of BMI versus HEP in reducing (1) depressive symptoms, (2) anxiety symptoms, and (3) the efficacy of BMI versus HEP in reducing the likelihood of hospitalization.DesignIn this study, we analyzed 6-month follow-up data from an 8-week assessor-blinded parallel RCT, which evaluated the efficacy of a BMI against an active control, HEP, in patients receiving hemodialysis with symptoms of depression and/or anxiety.SettingThe study took place at hemodialysis centers in 4 tertiary-care hospitals in Montreal, Canada.ParticipantsParticipants included adults aged ≥18 years who were receiving in-center hemodialysis 3 times per week and had symptoms of depression and/or anxiety as indicated by a score ≥6 on the Patient Health Questionnaire-9 (PHQ-9) and/or the General Anxiety Disorder-7 (GAD-7).MethodsParticipants were randomized to the treatment arm (BMI) or the active control arm (HEP) and completed assessments at baseline, 8 weeks, and 6-month follow-up. Depression was assessed using the PHQ-9, and anxiety was assessed by the GAD-7. Hospitalization rates were assessed using medical chart information.ResultsWe observed significant decrease in depression scores over 6 months in both BMI and HEP groups, with no significant difference between groups. Anxiety scores significantly decreased over 6 months, but only in the BMI group. Brief Mindfulness Intervention and Health Enhancement Program were comparable in terms of hospitalization rates.LimitationsThe limitations of our study include the modest sample size and lack of a third arm such as a waitlist control.ConclusionsOur results suggest that the beneficial effects of BMI and HEP for improving mood disorder symptoms in patients receiving dialysis persist at 6-month follow-up. Both interventions showed sustained effects for depressive symptoms, but BMI may be more useful in this population given its efficacy in reducing anxiety symptoms as well.Trial registrationPrior to recruitment, the trial had been registered (ClinicalTrials.gov Identifier: NCT03406845).
| S-EPMC8902179 | biostudies-literature
Project description:BackgroundMaternal prenatal depressive or anxiety symptoms are associated with adverse maternal and infant health outcomes. With prevalence rates of maternal prenatal depression and anxiety ranging between 10 and 20%, attempts to identify effective interventions to reduce symptoms are priority. There are indications that probiotics can reduce symptoms of maternal depression or anxiety. Probiotics ingested by the mother may thus offer a promising and accessible intervention to complement existing treatments.MethodsThe Probiotics in Pregnancy (PIP) pilot trial is a double-blind, placebo-controlled, randomized pilot trial. While one group orally consumes a probiotic mixture (Ecologic® Barrier; 2,5 × 109 colony forming units/g; 2 g; daily), the other group consumes a placebo, from between 26 and 30 weeks gestation until delivery. Subjects are randomly allocated (1:1) to the intervention or placebo group. Forty healthy pregnant women with symptoms of depression or anxiety and uncomplicated pregnancies at randomization will be included. The primary aim is to determine the feasibility and acceptability of a probiotic trial to reduce symptoms of maternal depression or anxiety in pregnancy. The secondary aim is to exploratorily compare the potential effect of probiotics, compared to placebo, on depressive and/or anxiety symptoms, maternal stress (i.e. reported/hair cortisol), maternal vaginal and intestinal microbiota, and by possibly affecting maternal mood and microbiota, maternal bonding to offspring, infant microbiota and infant crying.DiscussionResults of this pilot trial will help determine whether or not to proceed with a full trial after the pilot trial, and if so, whether revisions should be made to the study protocol and procedures before conducting a full randomized controlled trial. Additionally, they are expected to provide insights into whether changes in psychological, behavioral and biological parameters can be attributed to the probiotic intervention.Trial registrationNetherlands Trial Register, NTR6219 . Registered on 28 February 2017.
| S-EPMC6637581 | biostudies-literature