Randomized Waitlist Control Trial Research Articles

Developing Self-Compassion in Healthcare Professionals Utilising a Brief Online Intervention: A Randomised Waitlist Control Trial.

(1) Background: The level of stress experienced by staff in the healthcare sector is highly prevalent and well documented. Self-compassion may support the health and wellbeing of individuals and enable them to stay well at work. This study aimed to understand whether a brief, online, self-guided, novel intervention improved the health and wellbeing of healthcare professionals. (2) Methods: In a parallel randomised controlled trial, a volunteer sample of healthcare professionals were assigned to an intervention group (n = 110) or a waitlist control group (n = 80). Measures of self-compassion, mental wellbeing, stress and burnout were collected by an online questionnaire at baseline, post-programme and, for the intervention group, at follow-up. (3) Results: This intervention appeared to be effective in increasing self-compassion and mental health and decreasing stress and burnout. Significant group effects and significant time × group interactions for overall self-compassion [F (2, 183) = 32.72, p < 0.001; effect size ηp2 = 0.226], mental wellbeing [F (2, 212) = 17.46, p < 0.001; effect size ηp2 = 0.135], perceived stress [F (2, 205) = 5.42, p = 0.006; effect size ηp2 = 0.46], personal burnout [F (2, 224) = 7.57, p = 0.001; effect size ηp2 = 0.063] and work burnout [F (2, 208) = 7.39, p = 0.001; effect size ηp2 = 0.062] were found. (4) Conclusions: This study shows promise that an affordable and scalable intervention can be effective for busy healthcare professionals operating in a significantly challenging environment.

Understanding and effectively mitigating code review anxiety

Anxiety about giving and receiving code reviews has been documented as a common occurrence that leads to developers avoiding code reviews by procrastinating and limiting their cognitive engagement with them. This avoidance not only increases anxiety in the long term, but also prevents developers, their teams, and their organizations from accessing the technical and sociocognitive benefits of effective and efficient code reviews. However, software research has not yet empirically examined code review anxiety, and from this, tractable intervention targets and strategies for mitigating code review anxiety. In this study, we present an empirical framework for understanding the factors maintaining and exacerbating code review anxiety. Utilizing a randomized waitlist control trial, we also tested the effectiveness of a novel single-session cognitive-behavioral workshop intervention. Our results show evidence that positive impact can be obtained from a brief intervention and suggest code review anxiety can be successfully mitigated by targeting developers’ cost bias, anxiety self-efficacy, and self-compassion.

A randomized waitlist control trial of the Make the Connection® online program for caregivers of infants and young children: Study protocol.

A positive child-caregiver relationship is one of the strongest determinants of child health and development, yet many caregivers report challenges in establishing a positive relationship with their child. For over 20 years, Make the Connection® (MTC), an evidence-based parenting program, has been delivered in-person by child-caring professionals to over 120,000 parents to improve positive parenting behaviours and attitudes. Recently, MTC has been adapted into a 'direct to caregiver' online platform to increase scalability and accessibility. The purpose of this study is to evaluate the effectiveness of the online modality of MTC in increasing parenting knowledge, attitudes, and the perceived relationship with their child, and to understand barriers and facilitators to its access. Two hundred caregivers with children aged 0-3 years old will be recruited through Public Health agencies in Ontario, Canada. Participants will be randomly placed in the intervention or waitlist control group. Both groups will complete a battery of questionnaires at study enrolment and 8 weeks later. The intervention group will receive the MTC online program during the 8-week period, while the waitlist group will receive the program after an 8-week wait. The study questionnaires will address demographic information, caregivers' relational attitudes towards their infant, self-competence in their caregiver role, depression, and caregiver stress, as well as caregivers' and infants' emotion regulation. Results from this study will add critical knowledge to the development, scaling, and roll out of the MTC online program, thus increasing its capacity to reach a greater number of families. The study was registered with ClinicalTrials.gov on 15 March 2023 (NCT05770414).

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.

Facilitating the transition to posttreatment survivorship for adolescent and young adults: A randomized waitlist control trial of a virtual mind-body intervention.

12132 Background: Adolescent and young adults (AYAs) with cancer experience chronic stress and poor quality of life, particularly in early posttreatment as AYAs grapple with a “new normal.” Mind-body programs introduced early posttreatment hold promise for providing AYAs with skills to mitigate the adverse psychosocial and physiological effects of stress. Methods: We adapted and piloted an 8-session virtual, mind-body stress management and resilience group program for AYAs (3RP-AYA) to support the posttreatment transition. AYAs were randomized to receive the 3RP-AYA immediately (intervention group; IG) or after 3 months (waitlist control; WC). Data were collected at baseline (T0), 3 (T1) and 6 months (T2). We assessed feasibility by examining 3RP-AYA participation and survey completion rates. Paired-samples t-tests evaluated within-group effects of the 3RP-AYA on coping, distress (worry, depression, uncertainty intolerance), and resilience from T0-T1 (intervention period for IG, waitlist period for WC). Independent-samples t-tests of T0-T1 change scores for each group tested between-group differences in strength of change. Cohen’s d characterized strength of within- and between- group differences. Acceptability (i.e., content satisfaction and perceived helpfulness) was assessed at progam end (T1 for IG, T2 for WC). Results: From 05/19-09/20, 72 AYAs (77% participation rate; Mage = 23.8; 73.6% female; mean 18-months posttreatment; 59.7% non-Hispanic white; 20.8% Hispanic; 25% international) were randomized to IG (n = 35) or WC (n = 37); 85.9% completed 6/8 sessions (median = 7), and 87.5% completed the T1 survey. At enrollment, AYAs presented with elevated worry (M = 52.5, SD = 12.2) and uncertainty intolerance (M = 33.8, SD = 8.7), resembling patients with generalized anxiety. From T0-T1, the IG demonstrated moderate-to-large improvements in coping (d= 0.78, P &lt; .001), worry ( d =0.45, p = .04), depression ( d= .31, p = .11), tolerance of uncertainty ( d = .37, p = .06 ) and resilience ( d =.34, p = .09). When examining between-group differences, the IG showed significantly greater improvement in coping (d = 0.72, p = .01), with non-significantly greater change in worry, depression, tolerance of uncertainty, and resilience (ds = 0.27-0.49, ps &gt; .09) relative to WC. Notably, 96.6% of participants reported overall content satisfaction, and 91.7% reported the 3RP-AYA was helpful. Conclusions: A virtual mind-body program is feasible, acceptable and shows promising efficacy in improving coping and distress among posttreatment AYAs. Findings offer a paradigm shift in the way survivorship care is delivered, suggesting that integrating a mind-body program into early posttreatment survivorship care can facilitate adjustment to life after treatment. This can have downstream effects on the long-term emotional and physical health of AYAs. Clinical trial information: NCT03768336 .

Evaluation of the effects of the Online and Applied System for Intervention Skills (OASIS) with parents of children with ASD using a randomized waitlist control trial.

Evaluation of the effects of the Online and Applied System for Intervention Skills (OASIS) with parents of children with ASD using a randomized waitlist control trial.

SCI Thrive: Impact of a peer-led online self-management program

Objective To test the effectiveness of a peer-led online self-management program for individuals with spinal cord injury (SCI). Design Randomized waitlist control trial. Setting Community. Participants 184 adults with SCI. Interventions SCI Thrive is a peer-led self-management program with self-paced online content and video-sessions for live discussion. Outcome Measures Perceived quality of life, self-efficacy for health, participation. Results A total of 97 individuals (86 randomized plus 9 assigned to the final group) were assigned to treatment and 86 randomized to the waitlist. Participants were 51 years old on average (SD = 14.9), with 58% male, mean of 15.5 (SD = 14.0) years injured, with 59% cervical injuries and 64% incomplete injuries. The treatment group had significantly higher scores on CHART occupational subscale (P = .022), but no other differences were found at the end of 6 weeks. Analysis of all participants who completed SCI Thrive showed significant increase in self-efficacy between baseline (6.32) and 6 weeks (6.81; P < .001) which was maintained at 3 months post treatment (6.83; P = .001). Those who were more engaged in SCI Thrive reported higher quality of life (P = .001), self-efficacy (P = .007), and increased mobility on the CHART (P = .026). Conclusion SCI Thrive is a highly accessible program for individuals with SCI and shows promise for improving self-efficacy. Strategies to increase engagement should be added to maximize benefits. Measurement tools may have been impacted by COVID-19 pandemic. Further research on the efficacy of SCI Thrive is needed given feedback on benefit of a group focus area, such as on physical activity.

Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

IntroductionThis trial tests the efficacy of implementing a hybrid digital cognitive–behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol...

Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study.

BackgroundThe emotional health of adolescent and young adult (AYA) cancer survivors is compromised both during and after cancer treatment. Targeted programs designed to support AYAs’ ability to cope with stress in the years following treatment completion are lacking. Mind-body programs may ameliorate the negative psychological and emotional effects of stress and assist AYAs with managing the psychosocial challenges of early survivorship.ObjectiveOur randomized waitlist-control trial aims to assess the feasibility, acceptability, and preliminary efficacy of a virtual group program (Bounce Back) to promote stress management and resiliency among posttreatment AYAs.MethodsBounce Back is a stress management and resiliency program delivered via videoconference by a trained mental health clinician. Sessions were adapted from an evidence-based mind-body program (Stress Management and Resiliency Training - Relaxation Response Resiliency Program [SMART-3RP]) grounded in relaxation response elicitation, mindfulness, cognitive behavioral therapy, and positive psychology. Seventy-two AYAs (diagnosed with cancer between ages 14 years and 29 years and had completed cancer treatment within the last 5 years) were randomly assigned to the Bounce Back program or waitlist-control group and completed assessments at baseline, 3 months postbaseline, and 6 months postbaseline. The primary aim of the study is to determine the feasibility and acceptability of the Bounce Back program. Descriptive statistics, including means, frequencies, and ranges supplemented by qualitative exit interview feedback will be used to characterize the sample and to summarize feasibility and acceptability. The exploratory aims are to evaluate the preliminary effects of the program on stress coping and psychosocial outcome measures (ie, anxiety, depression) collected across the 3 time points.ResultsThis study was funded by the National Cancer Institute in July 2017. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board in October 2018 (Protocol 18-428). The randomized trial was conducted from July 2019 to March 2021. Quantitative data collection is complete, and qualitative exit interview data collection is ongoing. Results are expected to be published in peer-reviewed journals and presented at local, national, or international meetings in the coming years.ConclusionsFew evidence-based programs exist that tackle the key transitional issues faced by AYA cancer survivors. Future analyses will help us determine the feasibility and acceptability of the Bounce Back program and its impact on AYA stress coping and psychological well-being.Trial RegistrationClinicalTrials.gov NCT03768336; https://clinicaltrials.gov/ct2/show/NCT03768336International Registered Report Identifier (IRRID)DERR1-10.2196/34033

Integrating Financial Coaching and Referrals into a Smoking Cessation Program for Low-income Smokers: a Randomized Waitlist Control Trial.

Financial distress is a barrier to cessation among low-income smokers. To evaluate an intervention that integrated financial coaching and benefits referrals into a smoking cessation program for low-income smokers. Randomized waitlist control trial conducted from 2017 to 2019. Adult New York City residents were eligible if they reported past 30-day cigarette smoking, had income below 200% of the federal poverty level, spoke English or Spanish, and managed their own funds. Pregnant or breastfeeding people were excluded. Participants were recruited from two medical centers and from the community. The intervention (n = 208) offered smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial benefits and empowerment services. The waitlist control (n=202) was usual care during a 6-month waiting period. Treatment engagement, self-reported 7-day abstinence, and financial stress at 6 months. At 6 months, intervention participants reported higher abstinence (17% vs. 9%, P=0.03), lower stress about finances (β, -0.8 [SE, 0.4], P=0.02), and reduced frequency of being unable to afford activities (β, -0.8 [SE, 0.4], P=0.04). Outcomes were stronger among participants recruited from the medical centers (versus from the community). Among medical center participants, the intervention was associated with higher abstinence (20% vs. 8%, P=0.01), higher satisfaction with present financial situation (β, 1.0 [SE, 0.4], P=0.01), reduced frequency of being unable to afford activities (β, -1.0 [SE, 0.5], P=0.04), reduced frequency in getting by paycheck-to-paycheck (β, -1.0 [SE, 0.4], P=0.03), and lower stress about finances in general (β, -1.0 [SE, 0.4], P = 0.02). There were no group differences in outcomes among people recruited from the community (P>0.05). Among low-income smokers recruited from medical centers, the intervention produced higher abstinence rates and reductions in some markers of financial distress than usual care. The intervention was not efficacious with people recruited from the community. ClinicalTrials.gov Identifier: NCT03187730.

The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial

IntroductionLike many helping professionals in emotional labor occupations, clergy experience high rates of mental and physical comorbidities. Regular stress management practices may reduce stress-related symptoms and morbidity, but more research is needed into what practices can be reliably included in busy lifestyles and practiced at a high enough level to meaningfully reduce stress symptoms.Methods and analysisThe overall design is a preference-based randomized waitlist control trial. United Methodist clergy in North Carolina will be eligible to participate. The intervention and waitlist control groups will be recruited by email. The interventions offered are specifically targeted to clergy preference and include mindfulness-based stress reduction, Daily Examen, and stress inoculation training. Surveys will be conducted at 0, 12, and 24 weeks with heart rate data collected at 0 and 12 weeks. The primary outcomes for this study are self-reported symptoms of stress and heart rate at week 12 for each intervention compared to waitlist control; the secondary outcome is symptoms of anxiety comparing each intervention vs waitlist control.Ethics and disseminationEthical approval was obtained from the Duke University Campus IRB (2019-0238). The results will be made available to researchers, funders, and members of the clergy community.Strengths and limitations of this studyWhile evidence-based stress reduction practices such as mindfulness-based stress reduction (MBSR) exist, a wider variety of practices should be tested to appeal to different individuals.Clergy in particular may prefer, and consequently enact, spiritual practices like the Daily Examen, and individuals such as clergy who spend most of their time thinking and feeling may prefer experiential-based practices like stress inoculation training.If efficacious, the Daily Examen and stress inoculation training practices have high feasibility in that they require few minutes per day.This study is limited by the inclusion of Christian clergy of only one denomination.Trial registrationClinicalTrials.gov NCT04625777. November 12, 2020.

A randomized controlled trial of an app-delivered mindfulness program among university employees: effects on stress and work-related outcomes

PurposeThe purpose of this paper is to evaluate the impact on stress and work-related outcomes of an app-delivered mindfulness-based program (MBP; Headspace®) offered to employees in a UK higher education (HE) institution.Design/methodology/approachUsing a randomized waitlist control trial design, participants were randomly allocated to be offered a mindfulness-based program (MBP) immediately for 2 months or after a waiting list period of 2 months (WLC). Data were analyzed using Intention to Treat (ITT; MBP n = 62; WLC n = 63); with supplementary analysis restricting to those who completed all measures; (MBP n = 45; WLC n = 56) and then further restricting the MBP group to those who completed at least foundation level 1 of the app; (MBP n = 31; WLC n = 56).FindingsThe ITT analysis showed significant increases in several aspects of mindfulness and a significant reduction in perceived stress but no significant effects for work-related outcomes. Analysis restricted to MBP participants who completed the app foundation course showed a similar pattern but in addition showed significant increases in work-life balance and the emotional aspect of job engagement.Practical implicationsThe offer of the Headspace® app in the HE sector may result in reduced perceived stress. If improvements in work-related outcomes are also to be seen, then users need to be encouraged to complete a minimum level of practice.Originality/valueEffect size estimates for stress and work-related outcomes of an app-delivered MBP contribute to the evolving picture of MBPs in the workplace.

A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children: Protocol for a Waiting-List Randomized Controlled Trial.

BackgroundRural Latino children with asthma suffer high rates of uncontrolled asthma symptoms, emergency department visits, and repeat hospitalizations. This vulnerable population must negotiate micro- and macrolevel challenges that impact asthma management, including language barriers, primary care access, parental time off from work, insurance coverage, distance from specialty sites, and documentation status. There are few proven interventions that address asthma management embedded within this unique context.ObjectiveUsing a bio-ecological approach, we will determine the feasibility of a patient-centered collaborative program between rural Latino children with asthma and their families, school-based nursing programs, and primary care providers, facilitated by the use of a smartphone-based mobile app with a Spanish-language interface. We hypothesize that improving communication through a collaborative, patient-centered intervention will improve asthma management, empower the patient and family, decrease outcome disparities, and decrease direct and indirect costs.MethodsThe specific aims of this study include the following: (1) Aim 1: produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma, (2) Aim 2: develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in Aim 1, and (3) Aim 3: investigate the feasibility of the patient-centered asthma intervention from Aim 2 using a waiting-list randomized controlled trial (RCT) to investigate the effects of the intervention on school days missed and medication adherence.ResultsMobile app translation, initial usability testing, and app software refinement were completed in 2019. Analysis is in progress. Preliminary protocol testing is underway; we anticipate that the waiting-list RCT, using the refined protocol developed in Aim 2, will commence in fall 2020.ConclusionsTailored, technology-based solutions have the potential to successfully address issues affecting asthma management, including communication barriers, accessibility issues, medication adherence, and suboptimal technological interventions.Trial RegistrationClinicalTrials.gov NCT04633018; https://www.clinicaltrials.gov/ct2/show/NCT04633018International Registered Report Identifier (IRRID)DERR1-10.2196/18977

Efficacy of a two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol for depression and generalized anxiety disorder: A randomized waitlist control trial.

This parallel randomized controlled trial aimed to evaluate the effect of acceptance and commitment therapy (ACT) focused on disrupting repetitive negative thinking (RNT) versus a waitlist control (WLC) in the treatment of depression and generalized anxiety disorder (GAD). Forty-eight participants with a main diagnosis of depression and/or GAD were allocated by means of simple randomization to a 2-session RNT-focused ACT intervention or to the WLC. The primary outcomes were emotional symptoms as measured by the Depression, Anxiety, and Stress Scales-21. Process outcomes included ACT- and RNT-related measures: general RNT, experiential avoidance, cognitive fusion, values, and generalized pliance. At the 1-month follow-up, linear mixed effects models showed that the intervention was efficacious in reducing emotional symptoms (d = 2.42, 95% confidence interval [1.64, 3.19]), with 94.12% of participants in the RNT-focused ACT condition showing clinically significant change in the Depression, Anxiety, and Stress Scales-21 total scores versus 9.09% in the WLC condition (70% vs. 8% in intention-to-treat analysis). The intervention effects were maintained at the 3-month follow-up. No adverse events were found. A very brief RNT-focused ACT intervention was highly effective in the treatment of depression and GAD. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Effect of acceptance and commitment therapy in improving interpersonal skills in adolescents: A randomized waitlist control trial

This parallel randomized controlled trial evaluated the effect of acceptance and commitment therapy (ACT) focused on repetitive negative thinking (RNT) versus a waitlist control (WLC) in improving interpersonal skills in adolescents with problems of social and school adaptation. Forty-two adolescents (11–17 years) agreed to participate. Participants were allocated through simple randomization to the intervention condition or the waitlist control condition. The intervention was a 3-session, group-based, RNT-focused ACT protocol. The primary outcome was the performance on a test of interpersonal skills (Interpersonal Conflict Resolution Assessment, ESCI). At posttreatment, repeated measures ANOVA showed that the intervention was efficacious in increasing overall interpersonal skills (d = 2.62), progress in values (d = 1.23), and reducing emotional symptoms (d = 0.98). No adverse events were found. A brief RNT-focused ACT intervention was highly efficacious in improving interpersonal skills and reducing emotional symptoms in adolescents.

Effects of an Interactive Web Training to Support Parents in Reducing Challenging Behaviors in Children with Autism.

Many children with autism spectrum disorder (ASD) engage in challenging behaviors, which may interfere with their daily functioning, development, and well-being. To address this issue, we conducted a four-week randomized waitlist control trial to examine the effects of a fully self-guided interactive web training (IWT) on (a) child engagement in challenging behaviors and (b) parental intervention. After 4 weeks, parents in the treatment group reported lower levels of challenging behaviors in their children and more frequent use of behavioral interventions than those in the waitlist groups. Furthermore, within-group analyses suggest that these changes persisted up to 12 weeks following completion of the IWT. Our results highlight the potential utility of web training, but our high attrition rate and potential side effects prevent us from recommending the training as a standalone treatment.

Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial.

BackgroundMany cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs.ObjectiveThe aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app.MethodsThe Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use.ResultsParticipants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019.ConclusionsThis mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF.Trial RegistrationNetherlands Trial Register NL6642; https://www.trialregister.nl/trial/6642.International Registered Report Identifier (IRRID)DERR1-10.2196/15969

Supplemental Material for Efficacy of a Two-Session Repetitive Negative Thinking-Focused Acceptance and Commitment Therapy (ACT) Protocol for Depression and Generalized Anxiety Disorder: A Randomized Waitlist Control Trial

Supplemental Material for Efficacy of a Two-Session Repetitive Negative Thinking-Focused Acceptance and Commitment Therapy (ACT) Protocol for Depression and Generalized Anxiety Disorder: A Randomized Waitlist Control Trial

Multicentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: protocol for the friends project

IntroductionAdolescents with brain injury frequently have difficulties with social competence, which persist into adulthood affecting their participation in daily life. To date, there has been limited research into the efficacy...

The Effects of an Online Mindfulness Intervention on Perceived Stress, Depression and Anxiety in a Non-clinical Sample: A Randomised Waitlist Control Trial

Mindfulness interventions have been shown to be effective for health and wellbeing, and delivering mindfulness programmes online may increase accessibility and reduce waiting times and associated costs; however, research assessing the effectiveness of online interventions is lacking. We sought to: (1) assess the effects of an online mindfulness intervention on perceived stress, depression and anxiety; (2) assess different facets of mindfulness (i.e. acting with awareness, describing, non-judging and non-reacting) as mechanisms of change and (3) assess whether the effect of the intervention was maintained over time. The sample was comprised of 118 adults (female, n = 95) drawn from the general population. Using a randomised waitlist control design, participants were randomised to either an intervention (INT) or waitlist control (WLC) group. Participants completed the online intervention, with the WLC group starting after a 6-week waitlist period. Participants completed measures of depression (PHQ-9), anxiety (GAD-7) and perceived stress (PSS-10) at baseline, post-treatment, 3- and 6-month follow-up. Participants who completed the mindfulness intervention (n = 60) reported significantly lower levels of perceived stress (d = − 1.25 [− 1.64, − 0.85]), anxiety (d = − 1.09 [− 1.47, − 0.98]) and depression (d = − 1.06 [− 1.44, − 0.67]), when compared with waitlist control participants (n = 58), and these effects were maintained at follow-up. The effect of the intervention was primarily explained by increased levels of non-judging. This study provides support for online mindfulness interventions and furthers our understanding with regards to how mindfulness interventions exert their positive effects.