A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners.
ABSTRACT: Background:Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design. Methods:Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ??30% of eligible couples consent, ??70% of enrolled couples are retained, and ??50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial. Discussion:This trial will provide important information regarding the feasibility of a behavioral intervention in a vulnerable yet understudied population using videoconferencing and descriptive data regarding spiritual well-being and other indices of QOL in both mNSCLC patients and their partners. Trial registration:ClinicalTrials.gov NCT02596490.
Project description:<h4>Introduction</h4>Mindfulness is a promising intervention for female sexual dysfunction (FSD); however, of the mindfulness interventions studied, few treat the woman and her partner.<h4>Aim</h4>We developed a brief online mindfulness, resilience, and psychoeducation intervention, Stress Management and Resiliency Training for Sexuality (Sex SMART), for women with sexual health concerns and their partners.<h4>Methods</h4>Women with female sexual interest/arousal disorder and their partners were recruited between February 24, 2015, and October 6, 2016, and randomized to treatment or control groups (received educational pamphlets). The treatment intervention comprised of an online SMART and sexual health psychoeducation module.<h4>Main outcome measures</h4>The Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), Sexual Desire Inventory-2 (SDI-2), Revised Dyadic Adjustment Scale (RDAS), International Index of Erectile Function (IIEF), and other subjective measures were used to assess sexual function and sexual distress at baseline and 12 weeks.<h4>Results</h4>The study included 60 women and their partners (30 couples in each group). In both groups, sexual function by total FSFI scores and sexual distress scores significantly improved at 12 weeks compared with baseline, with no significant between-group differences (FSFI effect estimate for Sex SMART vs control = +1.4 (90% CI [-0.6 to +3.4]; P=.13). Both participants and partners randomized to the intervention reported significantly improved attitude and feelings, comfort as a sexual person, and subjective sexual functioning at 12 weeks. The findings provide preliminary evidence for efficacy of an online intervention for couples with sexual health problems.<h4>Conclusions</h4>A brief online mindfulness, resilience, and psychoeducation-based intervention showed no significant improvement in many outcomes (FSFI, FSDS-R, SDI-2, RDAS) of sexual health versus controls. Although this is the first online randomized controlled trial to evaluate a mindfulness-based therapy intervention, it was limited by its lack of population diversity and high attrition rate. Significant improvements in subjective sexual health and partner sexual function by the International Index of Erectile Function were reported only in the intervention group. Rullo JE, Sood R, Fokken SC, et al. Couples' Use of Online Stress Management and Resiliency Training for Sexual Health Concerns: A Randomized Controlled Trial. Sex Med 2021;9:100404.
Project description:BACKGROUND:Innovative interventions are needed to address the increasing mental health needs of university students. Given the demonstrated anxiolytic and antidepressant benefits of mindfulness training, we developed an 8-week, Web-based Mindfulness Virtual Community (MVC) intervention informed by cognitive behavioral therapy (CBT) constructs. OBJECTIVE:This study investigated the efficacy of the MVC intervention in reducing symptoms of depression, anxiety, and stress among undergraduate students in Toronto, Canada. The secondary outcomes included quality of life, life satisfaction, and mindfulness. METHODS:The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students' preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to video-based modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules. A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-face CBT; results for the latter group are presented elsewhere. Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting. The online surveys at baseline (T1), 4 weeks (T2), and 8 weeks (T3) included the Patient Health Questionnaire-9 item, Beck Anxiety Inventory, Perceived Stress Scale, Quality of Life Scale, Brief Multi-Dimensional Students Life Satisfaction Scale, and Five-Facet Mindfulness Questionnaire. Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible confounders (gender, age, birth country, paid work, unpaid work, physical activities, self-rated health, and mental health counseling access). RESULTS:Of the 113 students who provided T1 data, 28 were males and 85 were females with a mean age of 24.8 years. Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39) groups were similar in sociodemographic characteristics at T1. At T3 follow-up, per adjusted comparisons, there were statistically significant reductions in depression scores for F-MVC (score change -4.03; P<.001) and P-MVC (score change -4.82; P<.001) when compared with WLC. At T3, there was a statistically significant reduction in anxiety scores only for P-MVC (score change -7.35; P=.01) when compared with WLC. There was a statistically significant reduction in scores for perceived stress for both F-MVC (score change -5.32; P<.001) and P-MVC (score change -5.61; P=.005) compared with WLC. There were statistically significant changes at T3 for quality of life and mindfulness for F-MVC and P-MVC vs WLC but not for life satisfaction. CONCLUSIONS:Internet-based mindfulness CBT-based interventions, such as F-MVC and P-MVC, can result in significant reductions in symptoms of depression, anxiety, and stress in a student population. Future research with a larger sample from multiple universities would more precisely test generalizability. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.
Project description:Background:Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design. Methods:Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45?min each) over the course of patients' standard radiotherapy (6?weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6?weeks and then again 3?months later. The primary outcome is feasibility (i.e., ??50% of eligible dyads consent, ??70% of enrolled dyads complete all assessments, and ??50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial. Conclusion:This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers. Trial registration:ClinicalTrials.gov NCT02481349.
Project description:OBJECTIVE:(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. DESIGN AND SETTING:Parallel-group, randomized controlled pilot trial conducted at a university. PARTICIPANTS:Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). INTERVENTIONS:Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. MAIN OUTCOME MEASURES:Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. RESULTS:Most adolescents attended ?80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). CONCLUSIONS:A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138 clinicaltrials.gov.
Project description:<h4>Introduction</h4>Sexual dysfunction is one of the most common side effects of allogeneic haematopoietic stem cell transplantation (HSCT) for haematological cancers. Problems can persist between 5 and 10?years post-transplant and impact mood, couple intimacy and relationship satisfaction. Few intervention studies, however, target sexual dysfunction in patients post-HSCT. This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual intervention for HSCT survivors and their partners post-transplantation.<h4>Methods and analysis</h4>Fifteen allogeneic HSCT survivors and their partners will be recruited. Patients who are more than 3 months post-transplantation will be sent invitation letters describing the couples' psychosexual intervention that will be offered through this study. The intervention will comprise two components: (1) psychosexual education about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant; (2) emotionally focused therapy-based relationship education programme for couples delivered by a clinical psychologist (four sessions of 1.5?hours each). Couples who consent to participate will be administered a series of measures assessing mood, relationship satisfaction and sexual dysfunction preintervention and post-intervention, as well as satisfaction with the intervention postintervention. Feasibility of the intervention will be examined via recording enrolment rate, adherence, compliance with completing outcome measures and fidelity of intervention delivery.<h4>Ethics and dissemination</h4>Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national and international conferences and published in a peer-reviewed journal so that in can be accessed by clinicians involved in the care of allogeneic HSCT patients. If this intervention is found to be feasible and acceptable, its impact will be examined in a future randomised controlled trial and subsequently implemented as part of routine care in the allogeneic HSCT population.
Project description:OBJECTIVES:The purpose of this randomized controlled trial was to evaluate the effects of a specialized yoga program for individuals with a spinal cord injury (SCI) on pain, psychological, and mindfulness variables. MATERIALS AND METHODS:Participants with SCI (n=23) were outpatients or community members affiliated with a rehabilitation hospital. Participants were randomized to an Iyengar yoga (IY; n=11) group or to a 6-week wait-list control (WLC; n=12) group. The IY group participated in a twice-weekly 6-week seated IY program; the WLC group participated in the same yoga program, after the IY group's yoga program had ended. Pain, psychological, and mindfulness measures were collected at two time points for both groups (within 1-2 weeks before and after program 1 and at a third time point for the WLC group (within 1 week after program 2). RESULTS:Linear mixed-effect growth models were conducted to evaluate the main effects of group at T2 (postintervention), controlling for T1 (preintervention) scores. T2 depression scores were lower (F1,18=6.1, P<0.05) and T2 self-compassion scores higher (F1,18=6.57, P< 0.05) in the IY group compared to the WLC group. To increase sample size and power, the two groups were combined and analyzed across time by comparing pre- and postintervention scores. Main effects of time were found for depression scores, (F1,14.83=6.62, P<0.05), self-compassion, (F1,16.6=4.49, P<0.05), mindfulness (F1,16.79=5.42, P<0.05), mindful observing (F1,19.82=5.06, P<0.05), and mindful nonreactivity, (F1,16.53=4.92, P<0.05), all showing improvement after the intervention. DISCUSSION:The results indicated that a specialized 6-week yoga intervention reduced depressive symptoms and increased self-compassion in individuals with SCI, and may also have fostered greater mindfulness.
Project description:Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles.
Project description:Background:Risky behaviors are related to poor outcomes among young adolescents. This study piloted a mindfulness based intervention, Learning 2 Breath Mindfulness Curriculum, focusing on the feasibility of programming and intervention effects on coping, affect, and trait mindfulness among at-risk adolescents. Further, the mindfulness based intervention was compared to an attention intervention. Methods:Sixth-grade level female students in a boarding school for at-risk youth randomly allocated to either the mindfulness intervention (n = 12) or an attention intervention (n = 11) for six weeks. Outcomes (i.e., primary coping, positive affect, and trait mindfulness) were assessed before and after the interventions. Results:Intervention groups did not differ in demographics or outcomes at baseline. Twenty-two of 23 (95.7%) registered participants attended all of the sessions. Participants completed 86.4% of study tools. Separate repeated measures ANOVAs revealed no significant interactions among group and time for primary coping, positive affect, or mindfulness. However, positive affect did increase [F(1, 17) = 10.675, p = 0.005, partial η 2 = 0.39] over time for both groups and there was a slight increase in trait mindfulness over time (although not statistically significant; p = 0.095, partial η 2 = 0.155]). Primary coping did not change with time. Conclusion:The mindfulness intervention utilized in the present study exhibited feasibility in this population. Although preliminary, mindfulness based interventions may contribute to positive affect among at-risk youth in a boarding school. Limitations and future directions are discussed.
Project description:Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.
Project description:The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators.This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety.Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables.We enrolled 45 patients (23 mindfulness and 22 control; age, 43-83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta =?-1.15; p = 0.059) improved in the mindfulness group.Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.