Waitlist Control Participants Research Articles

Training to Reconnect With Emotional Awareness Therapy: A Randomized Controlled Trial in Participants With Traumatic Brain Injury

ObjectiveTo examine the efficacy of an intervention, Training to Reconnect with Emotional Awareness Therapy (TREAT) at improving alexithymia, emotion dysregulation, anxiety, depression, anger, and global positive and negative affect in participants with traumatic brain injury (TBI). DesignRandomized, waitlist control (WLC) trial with 3-month follow-up. SettingOutpatient brain injury rehabilitation center. ParticipantsAdult participants, who were on average 11.37 years postcomplicated mild-to-severe TBI and also had elevated alexithymia (n=44), who were randomized to immediate treatment (TREAT; n=20) or WLC (WLC=24). InterventionsEight sessions, structured training program that teaches emotional awareness and discrete labeling of emotions. Main Outcome MeasuresToronto Alexithymia Scale-20, Levels of Emotional Awareness Scale, Difficulty with Emotion Regulation Scale, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9; State-Trait Anger Expression Inventory (STAXI), Positive and Negative Affect Schedule (PANAS); and Patient Global Impression of Change. ResultsThirty-four participants completed the study per protocol. Compared with WLC participants (n=16) who had not yet received the intervention, TREAT participants (n=18) had significantly less alexithymia, emotion dysregulation, anxiety, and depression (all P’s<.05) within approximately 1 week of completing the intervention. Before/after results from the pooled sample (n=34) showed significant improvements, immediately and 3 months after the intervention, on all outcomes except the STAXI and the Positive Affect subscale of the PANAS. On the Patient Global Impression of Change, a noticeable change in global emotional function and quality of life was reported by 80%. Intent-to-treat analyses (n=38) revealed similar results to the per protocol sample. ConclusionsFindings support the efficacy of TREAT for reducing alexithymia and emotion dysregulation in individuals with chronic TBI. Although outcomes were also promising for anxiety and depression, more research using attention-control designs are warranted to control for the attention received during treatment.

O075 Improving Sleep Health in Paramedics through an App-based Intervention: A Randomised Waitlist Control Trial

Abstract Introduction Paramedics engaging in shiftwork arrangements face unique challenges that impact their sleep health, potentially compromising performance and wellbeing. This study investigated whether tailored sleep health advice delivered through the Sleepfit mobile application improved sleep health in paramedics. Methods We conducted a two-group randomised waitlist-controlled trial. Fifty-eight paramedics were randomised to the intervention group (n = 29) or the waitlist group (n = 29). Intervention group participants trialled Sleepfit for 14 days, during which waitlist control participants continued as usual, before being provided with Sleepfit for 14 days. During the 14-day intervention period, Sleepfit provided tailored sleep health education for shift workers, relaxation exercises, and a sleep diary to track sleep quantity and quality. Measures of sleep health (e.g., ISI, FSS, ESS, SHI) were completed at baseline, 14 days following, and 3-month follow-up. Multiple linear regression models were conducted to test the impact of the intervention on sleep health outcomes. Results Participants reported an average two-point reduction in both ISI (p = 0.01) and SHI (p = 0.01) scores, as well as a significant improvement in sleep satisfaction (p = 0.01) at post-intervention measurement. All other measures remained unchanged. This may be due to limited intervention impact, insufficient participant numbers, a short intervention period, or a ceiling effect. Conclusion This study provides preliminary evidence supporting the use of Sleepfit as an intervention in improving measures of sleep health in some shiftworkers. Further investigations, including objective assessments of sleep, are needed to validate these self-report measures in larger cohorts of shiftworkers.

Emotional Availability (EA) Brief: Single Session Feedback and Coaching for Improving Fathers’ Emotional Availability for Children Across a Wide Developmental Spectrum

Fathers are a historically underrepresented population in developmental research and must be considered for their modern presentation in parenting processes. Emotional Availability (EA) is a construct that captures the parent-child relationship quality and predicts positive outcomes for children. A recently developed intervention, the EA Brief, is a program conceptualized for easy administration that may be utilized to improve father-child dyadic functioning across a range of child ages. The final sample of interested fathers was 18 fathers with children between 4-months and 13.5-years. For pretest sessions, all fathers completed surveys (demographic information, the Emotional Availability Self Report, and the Flourishing Scale) via Qualtrics, followed by a 20-minute filmed interaction via Zoom which was later coded for EA. Immediate Intervention Group (IIG) received one pretest before the intervention and one posttest after the intervention over a 3-5 week intervention delivery. The intervention involved a 2-hour interactive Zoom workshop where information about EA, attachment, and mindfulness was provided, a 1-hour individualized, Zoom EA feedback/coaching session, and two weeks of text reminders about the covered content. In contrast to the IIG, the Waitlist Control (WC) participants received two pretests (same assessments as above) separated by the 3-5 week time period corresponding to the timing of intervention delivery for the IIG. After the second pretest, they received the same intervention as the IIG. All IIG and WC fathers received posttest sessions (exact same assessments as for the pretests noted above). Across 16 target variables assessing EA, six observed variables showed post-intervention improvement (α &lt; 0.05) though no significant findings were found on self-reported measures. These findings suggest that fathers respond to programs that provide guidance for clinically informed, research-based parenting despite the program having limited effect on their self-perceptions of how they parent.

Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial

BackgroundPediatric research is crucial for the development of new scientific advancements, treatments, and therapies for adolescents. Yet relatively few pediatric clinical trials are conducted due to barriers to successful recruitment and retention, including knowledge and attitudes about clinical trials. Adolescents tend to experience greater autonomy to make decisions and have expressed interest in being part of the decision to participate in clinical trials. Increasing knowledge, positive attitudes, and self-efficacy related to clinical trials could positively impact the decision to participate in a pediatric clinical trial. However, there are currently few interactive, developmentally appropriate, web-based resources available to educate adolescents about clinical trials. DigiKnowItNews: Teen was created as a multimedia educational website to address the relatively low levels of enrollment in pediatric clinical trials and need for information to empower adolescents to make decisions about participating in clinical trials.MethodsThis is a parallel group randomized controlled superiority trial to test the effectiveness of DigiKnowItNews: Teen, for improving factors related to clinical trial participation among adolescent and parents. Eligible parent-adolescent (ages 12 to 17 years) pairs will be randomly assigned to one of two conditions: intervention or wait-list control. All participants will complete pre- and post-test questionnaires and participants assigned to the intervention will receive access to review the DigiKnowItNews: Teen content for 1 week. Wait-list control participants will have the option to review DigiKnowItNews: Teen after study completion. The primary outcomes are knowledge about clinical research, attitudes, and beliefs toward pediatric clinical trials, self-efficacy for making decisions related to clinical trial participation, willingness to participate in a future clinical trial, procedural fears, and parent-adolescent communication quality. Overall feedback and satisfaction related to DigiKnowItNews: Teen will also be collected.DiscussionThe trial will evaluate the effectiveness of DigiKnowIt News: Teen, an educational website about pediatric clinical trials for adolescents. If found effective in promoting factors related to future pediatric clinical trial participation, DigiKnowIt News: Teen could be used by adolescents, along with their parents, as they make the decision to participate in a clinical trial. Clinical trial researchers can also use DigiKnowIt News: Teen to aid their participant recruitment efforts.Trial registrationClinicalTrials.gov NCT05714943. Registered on 02/03/2023.

Body confident coaching: a pilot randomized controlled trial evaluating the acceptability of a web-based body image intervention for coaches of adolescent girls

Coaches influence athletes’ body image, but often feel ill-equipped to address body image concerns and inadvertently perpetuate harmful body ideals. No evidence-based, empirically-tested body image intervention for coaches exists. This study evaluated the acceptability and preliminary efficacy of a novel web-based intervention (body confident coaching [BCC]), comprising five self-led 20-min modules. A pilot randomized controlled trial was conducted with 97 coaches of adolescent girls (M age = 36.6yrs, SD = 10.4; 70% women). Coaches were randomized into the intervention (n = 52) or waitlist control condition (n = 45). Intervention condition participants completed baseline self-assessments (demographics, target outcomes), took part in BCC over two weeks, and completed post-intervention self-assessments (target outcomes, acceptability, adherence). Waitlist control participants completed baseline (demographics, target outcomes) and post-intervention self-assessments (target outcomes), after which they received unmonitored access to the intervention. Intervention condition participants who completed post-intervention assessments (n = 16) finished all five modules and 75% reported engaging with the additional resources. Coaches found the intervention easy to follow, appropriate, useful, and enjoyable. Preliminary efficacy analyses indicated that the intervention condition reported higher levels of self-efficacy toward body image (η p 2 = .19), and lower levels of fat phobia (η p 2 = .39) and gender essentialist beliefs (η p 2 = .20) at post-intervention, compared to the waitlist condition. A limitation of this study is the small sample size and high attrition rate (51%), which may bias results. Following modifications to the intervention and trial protocol, BCC will be evaluated in a large-scale randomized controlled effectiveness trial. Lay summary: Body dissatisfaction is common among girls in sport, but coaches are unprepared and unskilled to address these concerns, and few resources for coaches exist. A new education program was found to be appropriate, useful, and enjoyable for coaches and improved their ability to recognize and address athletes’ body image concerns.

Tailored medication management intervention delivered by occupational therapists for older adults: A study protocol

Introduction: Medication management is an essential instrumental activity of daily living for older adults; however, 40–70% of older adults fail to take their medications correctly. Addressing medication management falls under the scope of occupational therapy, but there is a lack of evidence supporting occupational therapy interventions to improving medication management. This study’s primary aims are to examine the feasibility, acceptability, and preliminary efficacy of a Tailored Intervention for Medication Management delivered by occupational therapists to improve medication management. Method/Design: Single-blind, parallel-group randomized controlled equivalency trial, with two phases. Thirty community-dwelling older adults will be enrolled in this study. In Phase 1, participants in the treatment group will receive Tailored Intervention for Medication Management delivered remotely; those in the waitlist control will receive attention visits. In Phase 2, waitlist control participants will receive Tailored Intervention for Medication Management in person. The primary outcomes are feasibility and acceptability; secondary outcomes include preliminary efficacy of the intervention delivered by an occupational therapist remotely and in person. Additionally, the remote and in-person delivery methods will be compared to each other for equivalency. Discussion: Inability to manage medication and inappropriate polypharmacy are significant and prevalent problems that must be addressed so older adults can safely perform this essential instrumental activity of daily living. Trial Registration: ClinicalTrials.gov identifier NCT04717297.

Treating Young Adult Depression With Text-Delivered Cognitive Behavioral Therapy: A Pilot Randomized Clinical Trial

Young adults (ages 18 to 25) in the U.S. suffer from the highest rates of past-year major depressive episode and are the least likely to receive treatment compared to other age groups. As such, we examined the feasibility, acceptability, and efficacy of a text-message delivered cognitive behavioral therapy: CBT-txt with young adults. The study was a 2-month pilot RCT to test a 4-week intervention for depression that contained 197 text messages (average 12 texts every other day). The sample, recruited via Facebook and Instagram, was 102 U.S. young adults who presented with at least moderate depressive symptomatology. Assessments occurred at baseline prior to randomization and at 1 and 2 months post enrollment. The primary outcome, severity of depressive symptoms, was assessed using the Beck Depression Inventory II. Feasibility benchmarks were met and participants reported high levels of engagement with and acceptability of the intervention. Logistic regression indicated that treatment participants were three times as likely to have minimal or mild depression symptoms at 2 months compared to waitlist control participants. Latent change score modeling found that the strongest significant treatment effect appeared at the 1-month follow-up period, particularly for participants who began with severe depressive symptoms. Mediation analysis revealed significant indirect treatment effects of increases in behavioral activation on reducing depressive symptoms, suggesting a mechanism of change. Limitations were that the sample was relatively small and consisted of primarily women. These results provide initial evidence for the feasibility, acceptability, and efficacy of a text-delivered treatment for young adult depression.

Kundalini Yoga for Post-Treatment Lyme Disease: A Preliminary Randomized Study.

This study examined the adherence to and the potential benefit of Kundalini yoga (KY) for post-treatment Lyme disease syndrome (PTLDS). Participants were randomly assigned to 8 weeks of a KY small-group intervention or a waitlist control (WLC). Adherence was measured as attendance at KY group sessions. Primary outcomes assessed pain, pain interference, fatigue, and global health. Secondary outcomes assessed multisystem symptom burden, mood, sleep, physical and social functioning, cognition, and mindfulness. Linear mixed models were used to test changes in outcomes over time as a function of group assignment; intercepts for participants were modeled as random effects. Although the target sample size was 40 participants, the study concluded with 29 participants due to recruitment challenges. No KY participants dropped out of the study, and participants attended 75% of group sessions on average, but WLC retention was poor (57%). Regarding primary outcomes, there was no significant interaction between group and time. Regarding secondary outcomes, there was a significant interaction between group and time for multisystem symptom burden (p < 0.05) and cognition (p < 0.01); KY participants reported improved multisystem symptom burden and cognition over the course of the study compared to WLC participants. To enhance recruitment and retention, future trials may consider expanding geographic access and including supportive procedures for WLC participants. This preliminary study supports the need for a larger study to determine if KY reduces multisystem symptom burden and enhances cognition among people with PTLDS.

Yoga at Every Size: A Preliminary Evaluation of a Brief Online Size-Inclusive Yoga and Body Gratitude Journaling Intervention to Enhance Positive Embodiment in Higher Weight College Women.

The present pilot randomized controlled trial (RCT) evaluated the feasibility, acceptability, and preliminary efficacy of a 4-week online yoga and body gratitude journaling intervention for strengthening positive embodiment among racially-diverse higher weight college women. Seventy-five participants were initially randomized to either the yoga condition (n = 36) or to a wait-list control (n = 39). Participants completed measures of positive and negative body image, weight bias internalization, self-compassion, drive for leanness, and physical activity acceptance at both baseline and post. Preliminary results among the 42 analyzed completers (mean age = 20.9, SD = 2.4; 30% Black or African American) revealed acceptable feasibility given the low-intensity nature of the intervention reflected in a 36% attrition rate. Self-reported adherence was strong for the yoga component with 81% of participants indicating that they practiced with the videos ≥3–4 times per week as suggested. Although 71% reported completing the body gratitude journal ≥1–2 times per week, daily adherence was minimal. Acceptability was also high among participants randomized to the yoga condition as indicated by 86% expressing at least moderate levels of satisfaction with the overall program. Qualitative feedback from participants further supported the acceptability of the program and pointed to important areas in further refining the protocol in the future. Preliminary efficacy was supported by significant reductions in internal body shame and gains in body appreciation, functional body appreciation, functional body satisfaction, functional body awareness, and behavioral commitment to physical activity engagement among the yoga vs. wait-list control participants. These promising findings once replicated in larger, higher-powered trials may have important implications for extending the reach and accessibility of mind-body wellness practices like yoga to benefit racially-/ethnically-diverse college women of higher weight. This research is further responsive to the growing need for efficacious remotely-delivered, and scalable behavioral health interventions in the ongoing era of the COVID-19 pandemic. However, additional research is warranted to explore ways of enhancing engagement of participants with lower levels of positive embodiment and to further incentivize the journaling component of the intervention.

Brief Wellness Recovery Action Planning (WRAP®) as a mental health self-management tool for community adults in Hong Kong: A randomized controlled trial

Background Wellness Recovery Action Planning (WRAP ® ) is a recovery-oriented program designed for people with mental illness to improve well-being and self-manage symptoms. Aims This randomized controlled trial investigates the effectiveness of brief Wellness Recovery Action Planning (WRAP ® ) as a mental health self-management tool for adults without formal clinical diagnoses in Hong Kong. Methods 182 adults were randomly assigned to WRAP ® or waitlist control condition to investigate whether WRAP ® can promote mental well-being and reduce psychological distress for community adults with no known diagnosable mental disorders. Results Significant improvements were found in depressive (η p 2 = .11) and anxiety symptoms (η p 2 = .06), empowerment (η p 2 = .09), and personal recovery (η p 2 = .11) among WRAP ® participants compared with waitlist control participants. Moreover, changes in anxiety symptoms, hope, empowerment, and reliance on others were found to sustain at 3-month follow-up. Conclusions Brief WRAP® is an effective self-management tool in enhancing mental health and alleviating psychological distress for millennials living in the community.

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

Study designRandomized-controlled trial (RCT) with immediate intervention (IMM) and wait-list control (WLC) groups; WLC participants received the intervention during delivery to subsequent cohorts.ObjectivesInvestigate the effectiveness and feasibility of a virtually-delivered exercise intervention.SettingHome and community.MethodsA total of 168 middle-aged (49.6 [12.3] years old) men (57%) and women (43%) who lived an average 15.5 (12.3) years with spinal cord injury (SCI) participated. The 16-week program provides users (a) website access with exercise information, resources, and 16 skill-building modules; (b) virtual 60-minute, group-based weekly meetings; and (c) a starter package of exercise equipment. Primary outcomes included subjective physical activity (IPAQ) and objective exercise (Polar A300 wrist-based activity monitor and H7 heart rate strap). Secondary outcomes included fitness indices during a maximal arm crank test, plus self-reported exercise barriers, exercise self-efficacy, and goal-directed thinking.ResultsRCT results indicate significant between group differences in participants’ self-reported weekly time spent in vigorous-intensity PA and goal directed thinking but not for fitness changes. Data combined for IMM and WLC participants from Polar monitoring show participants performed 150 min per week of aerobic exercise plus reported significantly greater time spent in moderate-PA, vigorous-PA, self-efficacy for exercise and nutrition, goal directed thinking, and exercise barriers. Oxygen uptake (V̇O2 peak) and power output (watts max) were the only physiologic measures to demonstrate significant change, with a moderate effect size.ConclusionThis virtually-delivered program offers a promising approach to increase exercise among those with SCI and may help participants perceive fewer motivational barriers and greater self-efficacy.

Caregiver Nutritional Health Outcomes of the Simple Suppers Study: Results from a 10 Week, Two-Group Quasi-Experimental Family Meals Intervention.

Individuals from racial minority backgrounds, especially those in low income situations, are at increased risk for obesity. Family meals positively impact child nutritional health; however, there is limited evidence examining the impact on caregivers, particularly racial minority and income-restricted individuals. The objective of this intervention study was to determine the effect of Simple Suppers, a 10 week family meals program, on caregiver diet and nutrition outcomes. Intervention versus waitlist control participants were compared from baseline (T0) to post-intervention (T1). In addition, intervention participants were assessed at a 10 week follow-up time point (T2). This study was a two-group quasi-experimental intervention trial. Lessons (10 total) were delivered on a weekly basis for 90 min. Data were collected from intervention and waitlist control participants at T0 and T1, and intervention participants at T2. After baseline (T0) data collection, families enrolled in the immediate upcoming session of Simple Suppers (intervention group) or waited for 10 weeks (waitlist control group) to begin the program. Participants were caregivers of children ages 4–10 years. This study was conducted in a faith-based community center for underserved families in Columbus, Ohio. Primary outcomes were: diet quality assessed by Healthy Eating Index (HEI) total and component scores, and total energy intake (kcal/day); body mass index (BMI) (kg/m2), waist circumference (cm), systolic and diastolic blood pressure (BP) (mmHG); and self-efficacy for having healthy meals and menu planning (both scalar). The impact of the intervention (T0:T1) was assessed using generalized mixed-effects linear regression models. Maintenance of change in study outcomes among intervention participants (T1:T2) was examined with paired t-tests. 109 caregivers enrolled in this study. The retention rate at T1 was 90% (i.e., 98 participants). 56 of 68 intervention participants completed T2, resulting in a retention rate of 82%. Almost all (99%) were female, 61% were Black, and 50% were between 31 and 40 years old. In total, 40% had low income and 37% had low or very low food security. At T1, intervention vs. waitlist controls had a lower daily energy intake (p = 0.04), but an HEI-2010 component score for fatty acids (adequacy) that was lower indicating a lower dietary intake of fatty acids (p = 0.02), and a component score for empty calories (moderation) that was significantly lower indicating a higher intake of empty calorie foods (p = 0.03). At T1, intervention vs. waitlist controls also had a lower BMI (p < 0.001) and systolic BP (p = 0.04), and higher self-efficacy (p = 0.03). There were no group differences in other outcomes. At T2, intervention participants maintained the changes in daily energy intake, BMI, systolic BP, and self-efficacy that improved during the intervention period. There was no change (improvement) in the component score for fatty acids; however, the component score for empty calories significantly improved (p = 0.02). Engagement in the Simple Suppers program led to improvements in caregivers’ daily caloric intake, weight status, systolic blood pressure, and self-efficacy for family meals. Future research should further explore the dietary and nutritional health benefits of family meals among caregivers at the highest risk for obesity.

Pesky gNATs for children experiencing low mood and anxiety – A pragmatic randomised controlled trial of technology-assisted CBT in primary care

BackgroundCompared to the evidence base for adult populations, less is known about the effectiveness of technology-assisted CBT interventions for children aged 12 and under in real-world settings. AimsThis study aimed to evaluate the effectiveness of a technology-assisted CBT intervention called Pesky gNATs in primary care psychology services. MethodsA 2 × 3 (group by time) waitlist randomised controlled trial design was applied (n = 122), using the total internalising score from the Child Behaviour Checklist (CBCL) as the primary outcome measure; and a range of secondary outcomes. Participants were recruited from primary care services across Ireland and were assessed at baseline (Time 1), post-intervention (Time 2), and a follow-up at 3 months (Time 3). Repeated measures ANOVAs were used to analyse the data; in addition to Cohen's d for effect sizes, and the reliable change index (RCI) for clinically meaningful change. ResultsOverall, no significant between-group differences were found on primary or secondary measures. Both intervention and waitlist control groups experienced significantly positive change across all timepoints. However, participant retention rate at Time 2 was 66%; and fell to 44% at Time 3. Intervention group feedback from children and parent at Time 2 indicated high levels of acceptability and satisfaction with Pesky gNATs. The RCI showed a statistically significant result at Time 2: more participants from the intervention group (n = 9) moved from clinical to non-clinical levels on the primary outcome than did waitlist control participants (n = 0); but no differences were found at Time 3. ConclusionThis RCT did not demonstrate that Pesky gNATs is effective in providing clinically significant levels of change for low mood and anxiety. However, participant feedback showed high levels of acceptability and positive experiences However, given the high attrition rate and implementation challenges, further research is required to ascertain the effectiveness of technology-assisted CBT interventions such as Pesky gNATs.

A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy

Insomnia is highly prevalent among military veterans but access to cognitive-behavioral therapy for insomnia (CBT-I) is limited. Thus, this study examined the feasibility, acceptability, and potential efficacy of Insomnia Coach, a CBT-I-based, free, self-management mobile app. Fifty U.S. veterans, who were mostly male (58%) and mean age 44.5 (range = 28–55) years with moderate insomnia symptoms were randomized to Insomnia Coach (n = 25) or a wait-list control condition (n = 25) for 6 weeks. Participants completed self-report measures and sleep diaries at baseline, posttreatment, and follow-up (12 weeks postrandomization), and app participants (n = 15) completed a qualitative interview at posttreatment. Findings suggest that Insomnia Coach is feasible to use, with three quarters of participants using the app through 6 weeks and engaging with active elements. For acceptability, perceptions of Insomnia Coach were very favorable based on both self-report and qualitative interview responses. Finally, for potential efficacy, at posttreatment, a larger proportion of Insomnia Coach (28%) than wait-list control participants (4%) achieved clinically significant improvement (p = .049) and there was a significant treatment effect on daytime sleep-related impairment (d = −0.6, p = .044). Additional treatment effects emerged at follow-up for insomnia severity (d = −1.1, p = .001), sleep onset latency (d = −0.6, p = .021), global sleep quality (d = −0.9, p = .002), and depression symptoms (d = −0.8, p = .012). These findings provide preliminary evidence that among veterans with moderate insomnia symptoms, a CBT-I-based self-management app is feasible, acceptable, and promising for improving insomnia severity and other sleep-related outcomes. Given the vast unmet need for insomnia treatment in the population, Insomnia Coach may provide an easily accessible, convenient public health intervention for individuals not receiving care.

Online-Delivered Group and Personal Exercise Programs to Support Low Active Older Adults' Mental Health During the COVID-19 Pandemic: Randomized Controlled Trial.

BackgroundIn response to the COVID-19 pandemic, experts in mental health science emphasized the importance of developing and evaluating approaches to support and maintain the mental health of older adults.ObjectiveThe aim of this study was to assess whether a group-based exercise program relative to a personal exercise program (both delivered online) and waitlist control (WLC) can improve the psychological health of previously low active older adults during the early stages of the COVID-19 pandemic.MethodsThe Seniors COVID-19 Pandemic and Exercise (SCOPE) trial was a 3-arm, parallel randomized controlled trial conducted between May and September 2020 in which low active older adults (aged ≥65 years) were recruited via media outlets and social media. After baseline assessments, consented participants were randomized to one of two 12-week exercise programs (delivered online by older adult instructors) or a WLC condition. A total of 241 older adults (n=187 women) provided baseline measures (via online questionnaires), were randomized (ngroup=80, npersonal=82, ncontrol=79), and completed measures every 2 weeks for the duration of the trial. The trial’s primary outcome was psychological flourishing. Secondary outcomes included global measures of mental and physical health, life satisfaction, and depression symptoms.ResultsThe results of latent growth modeling revealed no intervention effects for flourishing, life satisfaction, or depression symptoms (P>.05 for all). Participants in the group condition displayed improved mental health relative to WLC participants over the first 10 weeks (effect size [ES]=0.288-0.601), and although the week 12 effect (ES=0.375) was in the same direction the difference was not statistically significant (P=.089). Participants in the personal condition displayed improved mental health, when compared with WLC participants, in the same medium ES range (ES=0.293-0.565) over the first 8 weeks, and while the effects were of a similar magnitude at weeks 10 (ES=0.455, P=.069) and 12 (ES=0.258, P=.353), they were not statistically significant. In addition, participants in the group condition displayed improvements in physical health when compared with the WLC (ES=0.079-0.496) across all 12 weeks of the study following baseline. No differences were observed between the personal exercise condition and WLC for physical health (slope P=.271).ConclusionsThere were no intervention effects for the trial’s primary outcome (ie, psychological flourishing). It is possible that the high levels of psychological flourishing at baseline may have limited the extent to which those indicators could continue to improve further through intervention (ie, potential ceiling effects). However, the intervention effects for mental and physical health point to the potential capacity of low-cost and scalable at-home programs to support the mental and physical health of previously inactive adults in the COVID-19 pandemic.Trial RegistrationClinicalTrials.gov NCT04412343; https://clinicaltrials.gov/ct2/show/NCT04412343

Within-subject evaluation of interim buprenorphine treatment during waitlist delays

BackgroundThe effectiveness of opioid agonist treatment for opioid use disorder (OUD) is well established, and delays to treatment are still common, particularly in rural geographic areas. In a randomized 12-week pilot study, we demonstrated initial efficacy of a technology-assisted Interim Buprenorphine Treatment (IBT) vs. continued waitlist control (WLC) for reducing illicit opioid use and other risk behaviors during waitlist delays. Upon completion of that parent trial, WLC participants were given the opportunity to receive 12 weeks of IBT, permitting an additional within-subject examination of IBT effects. MethodsSixteen WLC participants crossed over to receive IBT, involving buprenorphine maintenance with bi-monthly visits, medication administration at home via a computerized device, daily monitoring calls using an Interactive Voice Response (IVR) phone system, and IVR-generated random call-backs. Biochemically-verified illicit opioid abstinence, changes in psychosocial functioning, and HIV + HCV knowledge were examined among participants originally randomized to the WLC phase and who subsequently crossed over to IBT (IBTc). ResultsParticipants submitted a higher percentage of illicit opioid negative specimens at Weeks 4, 8, and 12 during IBT (75 %, 63 %, and 50 %) vs. WLC (0%, 0%, and 0%), respectively (p’s<.01). Participants also demonstrated improvements in anxiety, depression, and HIV and HCV knowledge (p’s<.01). Medication administration, daily IVR call and random call-back adherence and treatment satisfaction were also favorable. ConclusionsThis within-subject evaluation provides additional support for interim buprenorphine’s efficacy in reducing illicit opioid use and improving health outcomes during waitlist delays for more comprehensive treatment.

Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder

IntroductionIndividuals with social anxiety disorder (SAD) are at elevated risk of loneliness, yet little research has examined loneliness in this population. Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR) have demonstrated efficacy in treating SAD, yet research has not examined whether they lead to reductions in loneliness. MethodsThis sample comprised 108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to CBGT or MBSR following WL. Assessments were completed pre- and post-treatment, and 3-, 6-, 9-, and 12-month follow-up assessments. ResultsCompared to WL, individuals in CBGT and MBSR were less lonely at post-treatment; there was no difference between treatments after treatment or during follow-up. Greater reductions in social anxiety from pre- to post-treatment predicted lower levels of loneliness during follow-up. Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up. DiscussionIndividuals who experience reductions in their social anxiety during treatment may also feel less lonely following treatment. Reductions in loneliness also lead to improvements in social anxiety. Future research should continue to examine the relationship between social anxiety and loneliness and how interventions for SAD may help reduce loneliness.

Moving Online: A Pilot Clinical Trial of the Changing Talk Online Communication Education for Nursing Home Staff.

Staff-resident communication is a critical part of nursing home (NH) care. Reducing elderspeak and increasing person-centered communication has been shown to reduce behavioral symptoms experienced by persons living with dementia. An online version of a successful classroom-based communication-training program that reduced staff elderspeak and resident behavioral symptoms was evaluated. The objective of this study was to establish feasibility and determine the preliminary effects of the online program in preparation for a national pragmatic clinical trial. Seven NHs were randomized to immediate intervention or wait-list control conditions. The NHs were provided with the web-based training program that staff individually accessed. Primary outcomes were knowledge scores and communication ratings of a video-recorded interaction, using pre- to posttraining comparisons. Knowledge increased from a mean pretest score of 61.9% (SD = 20.0) to a mean posttest score of 84.6% (SD = 13.5) for the combined group. Knowledge significantly improved between Time 1 and Time 2 for the immediate intervention participants (p < .001), but not for the wait-list control participants (p = .091), and this difference was statistically significant (p < .001). Ability to recognize ineffective, inappropriate, nonperson-centered, and elderspeak communication improved after training (p < .001). The magnitude of improvement in communication recognition was comparable to that of the original classroom format. The adapted communication intervention was feasible and improved knowledge and communication. Online instruction can improve access to quality education and is an effective means to improve dementia care by overcoming barriers to in-person training. Clinical Trials Registration Number: NCT03849937.

Prevalence of harm in mindfulness-based stress reduction.

Mindfulness meditation has become a common method for reducing stress, stress-related psychopathology and some physical symptoms. As mindfulness programs become ubiquitous, concerns have been raised about their unknown potential for harm. We estimate multiple indices of harm following Mindfulness-Based Stress Reduction (MBSR) on two primary outcomes: global psychological and physical symptoms. In secondary analyses, we estimate multiple indices of harm on anxiety and depressive symptoms, discomfort in interpersonal relations, paranoid ideation and psychoticism. Intent-to-treat analyses with multiple imputations for missing data were used on pre- and post-test data from a large, observational dataset (n = 2155) of community health clinic MBSR classes and from MBSR (n = 156) and waitlist control (n = 118) participants from three randomized controlled trials conducted contemporaneous to community classes in the same city by the same health clinic MBSR teachers. We estimate the change in symptoms, proportion of participants with increased symptoms, proportion of participants reporting greater than a 35% increase in symptoms, and for global psychological symptoms, clinically significant harm. We find no evidence that MBSR leads to higher rates of harm relative to waitlist control on any primary or secondary outcome. On many indices of harm across multiple outcomes, community MBSR was significantly preventative of harm. Engagement in MBSR is not predictive of increased rates of harm relative to no treatment. Rather, MBSR may be protective against multiple indices of harm. Research characterizing the relatively small proportion of MBSR participants that experience harm remains important.

Effect of a Videoconference-Based Online Group Intervention for Traumatic Stress in Parents of Children With Life-threatening Illness

A substantial proportion of parents whose child is diagnosed with a life-threatening illness experience high levels of distress that can lead to long-term mental health difficulties. This can affect the child's recovery. To evaluate the efficacy of an acceptance and commitment therapy-based group intervention, delivered using videoconferencing, in reducing posttraumatic stress symptoms (PTSS) in these parents. This study was a randomized clinical trial of an intervention for parents with elevated acute stress symptoms. It was a single-site study conducted in a tertiary pediatric hospital in Australia. Parents of children aged 0 to 18 years admitted for a life-threatening illness or injury to the oncology, cardiology, or pediatric intensive care departments were eligible. Participants were screened for eligibility within the first month after diagnosis or admission and then were randomized to the intervention group or the waiting list control group 4 to 10 months after diagnosis or admission. Recruitment commenced January 2014, and final postintervention follow-up was completed in February 2018. Data analysis was performed from July to September 2018. Treatment was a psychological acceptance and commitment therapy-based group therapy program called Take a Breath, which consisted of a 6-session parent-mediated psychological intervention delivered via online videoconferences over the course of 8 weeks. Waiting list control participants received treatment as usual and were offered the intervention 3 months after randomization. The primary outcome was PTSS, as measured by the Posttraumatic Stress Disorder Checklist-Version 5 (total score range, 0-80, with higher scores indicating greater symptom severity). The PTSS was measured both before and immediately after the intervention. Changes in psychological skills taught within the intervention were also evaluated, including acceptance, mindfulness, values-based living, and psychological flexibility. Of 1232 parents who were assessed for eligibility, 313 were randomized; 161 were allocated to the waiting list control group, and 152 were allocated to the intervention group. Of those allocated, 44 parents in the waiting list group and 37 in the intervention group completed the postintervention questionnaire and were analyzed (81 participants total; mean [SD] age, 37.17 [6.43] years). Sixty-five participants (80.2%) were women, 48 participants (59.3%) were married, and 40 participants (49.4%) lived in rural or regional areas, or in a different state. In addition, 24 parents (29.6%) were in the cardiology illness group, 32 parents (39.5%) were in the oncology group, and 25 parents (30.9%) were in the pediatric intensive care unit group. The intervention group demonstrated significantly greater improvements in PTSS compared with the waiting list group (Cohen d = 1.10; 95% CI, 0.61-1.59; P = .03). The mean Posttraumatic Stress Disorder Checklist-Version 5 scores decreased from 31.7 (95% CI, 27.0-36.4) to 26.2 (95% CI, 21.8-30.7) in the waiting list control group and from 23.3 (95% CI, 18.6-28.1) to 17.8 (95% CI, 13.8-21.8) in the intervention group. The findings of this study support the use of acceptance and commitment therapy to reduce PTSS in parents of very ill children, regardless of diagnosis. These findings also suggest that a brief, group format using a videoconferencing platform can be used effectively to access hard-to-reach populations, particularly fathers and caregivers living in nonmetropolitan areas. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12611000090910.