Dataset Information

Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial.

ABSTRACT:

Background

Depression 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.

Objective

We 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.

Design

In 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.

Setting

The study took place at hemodialysis centers in 4 tertiary-care hospitals in Montreal, Canada.

Participants

Participants 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).

Methods

Participants 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.

Results

We 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.

Limitations

The limitations of our study include the modest sample size and lack of a third arm such as a waitlist control.

Conclusions

Our 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 registration

Prior to recruitment, the trial had been registered (ClinicalTrials.gov Identifier: NCT03406845).

SUBMITTER: Rigas C

PROVIDER: S-EPMC8902179 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial.

Rigas Christina C Park Haley H Nassim Marouane M Su Chien-Lin CL Greenway Kyle K Lipman Mark M McVeigh Clare C Novak Marta M Trinh Emilie E Alam Ahsan A Suri Rita S RS Mucsi Istvan I Torres-Platas Susana G SG Noble Helen H Sekhon Harmehr H Rej Soham S Lifshitz Michael M

Canadian journal of kidney health and disease 20220304

<h4>Background</h4>Depression 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.<h4>Objective</h4>We previously conducted a randomized controlled trial (RCT; n = ...[more]

PMID: 35273807

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Project description:Background and objectivesUp to 50% of patients undergoing hemodialysis suffer from symptoms of depression and/or anxiety. Access to traditional pharmacotherapies and psychotherapies for depression or anxiety in this patient population has been inadequate. The objective of this study was to investigate the feasibility and effectiveness of brief mindfulness meditation intervention for patients on hemodialysis with depression and anxiety symptoms.Design, setting, participants, & measurementsThis study was a randomized, controlled, assessor-blinded trial conducted in an urban hemodialysis unit. Forty-one patients were randomly assigned to intervention (n=21) and treatment-as-usual (n=20) groups. The intervention group received an 8-week individual chairside meditation intervention lasting 10-15 minutes, three times a week during hemodialysis. Feasibility outcomes were primarily assessed: enrollment rates, intervention completion rates, and intervention tolerability. Symptoms of depression and anxiety were measured using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder-7 (GAD-7).ResultsOf those deemed eligible for the study, 67% enrolled (41 of 61). Of the participants randomized to the intervention group, 71% completed the study, with meditation being well tolerated (median rating of 8 of 10 in a Likert scale; interquartile range=10-5 of 10). Barriers to intervention delivery included frequent hemodialysis shift changes, interruptions by staff or alarms, space constraints, fluctuating participant medical status, and participant fatigue. Meditation was associated with subjective benefits but no statistically significant effect on depression scores (change in PHQ-9, -3.0±3.9 in the intervention group versus -2.0±4.7 in controls; P=0.45) or anxiety scores (change in GAD-7, -0.9±4.6 versus -0.8±4.8; P=0.91).ConclusionsOn the basis of the results of this study, mindfulness meditation appears to be feasible and well tolerated in patients on hemodialysis with anxiety and depression symptoms. The study did not reveal significant effects of the interventions on depression and anxiety scores.PodcastThis article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_10_12_CJASNPodcast_17_12_.mp3.

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.

Project description:BackgroundPsychosocial, self-guided, internet-based programs are effective in treating depression and anxiety. However, the community uptake of these programs is poor. Recent approaches to increasing engagement (defined as both uptake and adherence) in internet-based programs include brief engagement facilitation interventions (EFIs). However, these programs require evaluation to assess their efficacy.ObjectiveThe aims of this hybrid implementation effectiveness trial are to examine the effects of a brief internet-based EFI presented before an internet-based cognitive behavioral therapy self-help program (myCompass 2) in improving engagement (uptake and adherence) with that program (primary aim), assess the relative efficacy of the myCompass 2 program, and determine whether greater engagement was associated with improved efficacy (greater reduction in depression or anxiety symptoms) relative to the control (secondary aim).MethodsA 3-arm randomized controlled trial (N=849; recruited via social media) assessed the independent efficacy of the EFI and myCompass 2. The myCompass 2 program was delivered with or without the EFI; both conditions were compared with an attention control condition. The EFI comprised brief (5 minutes), tailored audio-visual content on a series of click-through linear webpages.ResultsUptake was high in all groups; 82.8% (703/849) of participants clicked through the intervention following the pretest survey. However, the difference in uptake between the EFI + myCompass 2 condition (234/280, 83.6%) and the myCompass 2 alone condition (222/285, 77.9%) was not significant (n=565; χ21=29.2; P=.09). In addition, there was no significant difference in the proportion of participants who started any number of modules (1-14 modules) versus those who started none between the EFI + myCompass 2 (214/565, 37.9%) and the myCompass 2 alone (210/565, 37.2%) conditions (n=565; χ21<0.1; P=.87). Finally, there was no significant difference between the EFI + myCompass 2 and the myCompass 2 alone conditions in the number of modules started (U=39366.50; z=-0.32; P=.75) or completed (U=39494.0; z=-0.29; P=.77). The myCompass 2 program was not found to be efficacious over time for symptoms of depression (F4,349.97=1.16; P=.33) or anxiety (F4,445.99=0.12; P=.98). However, planned contrasts suggested that myCompass 2 may have been effective for participants with elevated generalized anxiety disorder symptoms (F4,332.80=3.50; P=.01).ConclusionsThis brief internet-based EFI did not increase the uptake of or adherence to an existing internet-based program for depression and anxiety. Individuals' motivation to initiate and complete internet-based self-guided interventions is complex and remains a significant challenge for self-guided interventions.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001565235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375839.

Project description:ObjectiveTo evaluate mindfulness-based intervention for hypertension with depression and/or anxiety.Methods10-week mindfulness-based intervention, including health education for hypertension, exclusively for the control group, was administered to the intervention group to assist sixty hypertension patients with depression/anxiety. Among them, the intervention group comprised 8 men and 22 women, with a mean age of 60.02 years and a mean duration of hypertension of 6.29 years. The control group consisted of 14 men and 16 women with a mean age of 57.68 years and a mean duration of hypertension of 6.32 years. The severity of depressive and/or anxiety symptoms was assessed using the 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder scale (GAD-7), along with blood pressure (BP) measurements taken twice daily. The study utilized a self-made self-efficacy scale and awareness of physical and mental health to evaluate mental health and state.ResultsThe depression PHQ-9 or GAD-7 scores reduced by 21.1% or 17.8% in the mindfulness-based intervention group, compared to the control (Z = -2.040, P = 0.041) post 10-week period, suggesting significant reduction in anxiety/stress. These results were consistent with a reduction in systolic BP of 12.24 mm Hg (t = 6.041, P = 0.000). The self-efficacy score of the mindfulness intervention group significantly improved compared to the control (t = 7.818, P < 0.001), while the awareness of physical and mental health in the mindfulness intervention group significantly improved compared to the control (χ2 = 5.781, P = 0.016).ConclusionMindfulness-based, short-term focused interventions provide modest relief for depression and/or anxiety and are effective in lowering blood pressure and improving self-efficacy scores.Trial registrationChinese Clinical Trial Registry, ChiCTR1900028258. Registered 16 December 2019, https://www.chictr.org.cn/showproj.html?proj=43627 .

Dataset Information

Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial.

Background

Objective

Design

Setting

Participants

Methods

Results

Limitations

Conclusions

Trial registration

Publications

Long-term Effects of a Brief Mindfulness Intervention Versus a Health Enhancement Program for Treating Depression and Anxiety in Patients Undergoing Hemodialysis: A Randomized Controlled Trial.

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