Self-administered Intervention Research Articles

Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial

IntroductionPost stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES.Methods and designOverall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation.DiscussionThe results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261).

Strategies to address common sleep disorders among middle-aged and older adults

Abstract Obstructive sleep apnea (OSA) is an underdiagnosed and prevalent condition in middle-aged and older adults, with a disproportionate burden of OSA in marginalized populations. Lack of appropriate and timely treatment puts many at risk of poor quality of life, comorbidity, motor vehicle crashes and increased health care utilization. Furthermore, social and environmental disparities were acknowledged as contributing to sleep health disparities, OSA health literacy and adherence to OSA treatment. This presentation will overview the social and environmental determinants of OSA prevalence and management. The presenter will also cover strategies to improve access and waiting time for OSA diagnosis and treatment in middle-aged and older adults, such as screening for OSA in general and marginalized populations, alternative at-home OSA detection solutions, involvement of alternative care providers in OSA care, alternative OSA targeted therapies, including accessible self-administered interventions, health equity interventions targeting OSA, and promotion of sleep-centered lifestyle approaches, including weight loss, diet and exercise.

Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics.

Adherence to study interventions is critical to the conduct of randomized controlled trials (RCTs). The relationships between participant characteristics and intervention adherence are understudied in pregnant populations. The purpose of this study was to conduct a secondary analysis of adherence to study capsules in a double-masked, placebo-controlled RCT of a probiotic intervention to reduce antenatal Group B Streptococcus colonization, in relationship to participant characteristics. We analyzed the relationship between capsule adherence rates and demographic characteristics among 81 RCT participants. Categorical variables were reported using counts and percentages, and continuous variables were expressed as means along with their standard deviations. For the univariate analyses, we compared demographic variables with adherence scores. A multivariate linear regression model was used to identify predictors of adherence. Average adherence was similar for control and probiotic group participants (P =.86) Univariate analysis showed that average adherence increased directly with age, education, and income. Participants who were partnered or living with others had higher average adherence compared with those who were single and living alone. Asian and White participants had the highest and Black participants had the lowest average, and there was no difference based on Hispanic ethnicity. Adjusting for all the variables in the regression, participants who identified as Black were significantly less likely to adhere to capsules than White participants, and those who were married or living with partners were more likely to adhere than the single participants. Diverse participants are critically important to RCTs. This secondary analysis provides evidence that participant characteristics and the social determinants of health play an important role in adherence to self-administered interventions in RCTs, although more research is needed. Our findings suggest that intentional consideration of RCT participant characteristics may allow for the development and tailoring of strategies to enhance intervention adherence. The study was registered on ClinicalTrials.gov (NCT03696953) on January 10, 2018.

Self-Administered Interventions Based on Natural Language Processing Models for Reducing Depressive and Anxiety Symptoms: Systematic Review and Meta-Analysis.

The introduction of natural language processing (NLP) technologies has significantly enhanced the potential of self-administered interventions for treating anxiety and depression by improving human-computer interactions. Although these advances, particularly in complex models such as generative artificial intelligence (AI), are highly promising, robust evidence validating the effectiveness of the interventions remains sparse. The aim of this study was to determine whether self-administered interventions based on NLP models can reduce depressive and anxiety symptoms. We conducted a systematic review and meta-analysis. We searched Web of Science, Scopus, MEDLINE, PsycINFO, IEEE Xplore, Embase, and Cochrane Library from inception to November 3, 2023. We included studies with participants of any age diagnosed with depression or anxiety through professional consultation or validated psychometric instruments. Interventions had to be self-administered and based on NLP models, with passive or active comparators. Outcomes measured included depressive and anxiety symptom scores. We included randomized controlled trials and quasi-experimental studies but excluded narrative, systematic, and scoping reviews. Data extraction was performed independently by pairs of authors using a predefined form. Meta-analysis was conducted using standardized mean differences (SMDs) and random effects models to account for heterogeneity. In all, 21 articles were selected for review, of which 76% (16/21) were included in the meta-analysis for each outcome. Most of the studies (16/21, 76%) were recent (2020-2023), with interventions being mostly AI-based NLP models (11/21, 52%); most (19/21, 90%) delivered some form of therapy (primarily cognitive behavioral therapy: 16/19, 84%). The overall meta-analysis showed that self-administered interventions based on NLP models were significantly more effective in reducing both depressive (SMD 0.819, 95% CI 0.389-1.250; P<.001) and anxiety (SMD 0.272, 95% CI 0.116-0.428; P=.001) symptoms compared to various control conditions. Subgroup analysis indicated that AI-based NLP models were effective in reducing depressive symptoms (SMD 0.821, 95% CI 0.207-1.436; P<.001) compared to pooled control conditions. Rule-based NLP models showed effectiveness in reducing both depressive (SMD 0.854, 95% CI 0.172-1.537; P=.01) and anxiety (SMD 0.347, 95% CI 0.116-0.578; P=.003) symptoms. The meta-regression showed no significant association between participants' mean age and treatment outcomes (all P>.05). Although the findings were positive, the overall certainty of evidence was very low, mainly due to a high risk of bias, heterogeneity, and potential publication bias. Our findings support the effectiveness of self-administered NLP-based interventions in alleviating depressive and anxiety symptoms, highlighting their potential to increase accessibility to, and reduce costs in, mental health care. Although the results were encouraging, the certainty of evidence was low, underscoring the need for further high-quality randomized controlled trials and studies examining implementation and usability. These interventions could become valuable components of public health strategies to address mental health issues. PROSPERO International Prospective Register of Systematic Reviews CRD42023472120; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023472120.

Effect of a Smartphone App (S-Check) on Actual and Intended Help-Seeking and Motivation to Change Methamphetamine Use Among Adult Consumers of Methamphetamine in Australia: Randomized Waitlist-Controlled Trial.

Interventions are required that address delays in treatment-seeking and low treatment coverage among people consuming methamphetamine. We aim to determine whether a self-administered smartphone-based intervention, the "S-Check app" can increase help-seeking and motivation to change methamphetamine use, and determine factors associated with app engagement. This study is a randomized, 28-day waitlist-controlled trial. Consenting adults residing in Australia who reported using methamphetamine at least once in the last month were eligible to download the app for free from Android or iOS app stores. Those randomized to the intervention group had immediate access to the S-Check app, the control group was wait-listed for 28 days before gaining access, and then all had access until day 56. Actual help-seeking and intention to seek help were assessed by the modified Actual Help Seeking Questionnaire (mAHSQ), modified General Help Seeking Questionnaire, and motivation to change methamphetamine use by the modified readiness ruler. χ2 comparisons of the proportion of positive responses to the mAHSQ, modified General Help Seeking Questionnaire, and modified readiness ruler were conducted between the 2 groups. Logistic regression models compared the odds of actual help-seeking, intention to seek help, and motivation to change at day 28 between the 2 groups. Secondary outcomes were the most commonly accessed features of the app, methamphetamine use, feasibility and acceptability of the app, and associations between S-Check app engagement and participant demographic and methamphetamine use characteristics. In total, 560 participants downloaded the app; 259 (46.3%) completed eConsent and baseline; and 84 (32.4%) provided data on day 28. Participants in the immediate access group were more likely to seek professional help (mAHSQ) at day 28 than those in the control group (n=15, 45.5% vs n=12, 23.5%; χ21=4.42, P=.04). There was no significant difference in the odds of actual help-seeking, intention to seek help, or motivation to change methamphetamine use between the 2 groups on the primary logistic regression analyses, while in the ancillary analyses, the imputed data set showed a significant difference in the odds of seeking professional help between participants in the immediate access group compared to the waitlist control group (adjusted odds ratio 2.64, 95% CI 1.19-5.83, P=.02). For participants not seeking help at baseline, each minute in the app increased the likelihood of seeking professional help by day 28 by 8% (ratio 1.08, 95% CI 1.02-1.22, P=.04). Among the intervention group, a 10-minute increase in app engagement time was associated with a decrease in days of methamphetamine use by 0.4 days (regression coefficient [β] -0.04, P=.02). The S-Check app is a feasible low-resource self-administered intervention for adults in Australia who consume methamphetamine. Study attrition was high and, while common in mobile health interventions, warrants larger studies of the S-Check app. Australian New Zealand Clinical Trials Registry ACTRN12619000534189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377288&isReview=true.

Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study

Mindfulness witnessed a substantial popularity surge in the past decade, especially as digitally self-administered interventions became available at relatively low costs. Yet, it is uncertain whether they effectively help reduce stress. In a preregistered (OSF https://doi.org/10.17605/OSF.IO/UF4JZ; retrospective registration at ClinicalTrials.gov NCT06308744) multi-site study (nsites = 37, nparticipants = 2,239, 70.4% women, Mage = 22.4, s.d.age = 10.1, all fluent English speakers), we experimentally tested whether four single, standalone mindfulness exercises effectively reduced stress, using Bayesian mixed-effects models. All exercises proved to be more efficacious than the active control. We observed a mean difference of 0.27 (d = −0.56; 95% confidence interval, −0.43 to −0.69) between the control condition (M = 1.95, s.d. = 0.50) and the condition with the largest stress reduction (body scan: M = 1.68, s.d. = 0.46). Our findings suggest that mindfulness may be beneficial for reducing self-reported short-term stress for English speakers from higher-income countries.

Internet-based self-administered intervention to reduce anxiety and depression symptomatology and improve well-being in 7 countries: protocol of a randomized control trial.

Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants. A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis. This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe.

Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial

BackgroundDepression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, including human support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. ObjectiveThe current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. MethodsThe proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 110 patient participants, with a loss-to-follow-up rate of 30 %. DiscussionA study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services. RegistrationClinicalTrials.gov; NCT06230237.

Utilization of the Keeping Hope Possible Toolkit with parents of children with life limiting and life threatening illnesses during the COVID-19 pandemic: Exploring pediatric nurses and allied healthcare provider opinions

BackgroundFor families with children diagnosed with complex illnesses, the COVID-19 pandemic added many challenges. In order to mitigate inevitable disruptions in pediatric care settings, caregivers may need added supports and resources. The Keeping Hope Possible (KHP) Toolkit is a self-administered intervention intended to enhance caregiving experiences of parents with a child with multiple needs. However, little is known about effectively disseminating the Toolkit. Purpose and methodsA qualitative, thematic analysis was conducted to explore the opinions and perceptions of pediatric nurses and allied healthcare providers (HCPs) in relation to the dissemination and use of the KHP Toolkit for use by families with complex medical needs. Structured interview data were analyzed from a sample of seven pediatric HCPs working in various care settings in one Canadian province. FindingsFive themes were developed including: Recognising Importance of the KHP Toolkit; Needing Support and Direction; Implementation and Use of the KHP Toolkit; Realizing Important Considerations for Success; and, Emphasizing Connection through Isolated Times. DiscussionParticipants recognized the importance of the KHP Toolkit for parents and extended family in a variety of settings to encourage self-care, daily structure, and connectedness. Thus, pediatric nurses' awareness and openness to the initial dissemination of the Toolkit is essential, and a subsequent interprofessional team approach will ensure consistent reminders and support for families. Application to practiceCareful assessment of family readiness for learning about and using the KHP Toolkit is essential, along with an interprofessional approach to consistent inquiry and support at each family encounter.

Guidance on how to involve people with lived experience in research on digital mental health interventions

IntroductionDigital technologies and interventions (defined as patient-facing or self-administered interventions delivered through a digital platform) have an increasing role in mental health care. It is key to ensure that appropriate patient and public involvement (PPI) is not overlooked when developing new digital mental health interventions (DMHIs). The unique perspective offered by those with lived experience can improve study conduct and design as well as ensure that interventions meet the needs of users, which may improve their quality and acceptability.ObjectivesTo develop guidance for the involvement of people with lived experience of severe mental illness in designing and conducting research on DMHIs.MethodsFour co-production workshops were arranged online with people who have lived experience of severe mental illness. Initial ideas were formulated in the first workshop and were then prioritised in the second workshop using the nominal group technique. The prioritised ideas were then refined in workshops three and four. Minutes were generated from each workshop and were validated by the those who took part. These minutes were analysed using thematic analysis.ResultsNineteen people with lived experience participated in the co-production workshops overall. Six people took part in one workshop only and 13 took part in multiple workshops. Two main themes were identified in this study: why do people become and remain involved in PPI?; and what areas should be discussed within PPI consultations? Three subthemes associated with the second theme were also identified. These are: areas related to specific types of DMHI; areas related to any type of DMHI; and what can make a difference within DMHIs? To ensure that people become and remain interested in PPI around DMHIs, it is important to provide a non-judgemental space for people with lived experience to discuss any concerns and ensure they feel valued during consultations. Aspects to consider discussing in PPI consultations around the development of DMHIs include the provision of safety and security within DMHIs, issues around digital exclusion and the potential impact of people’s symptoms on DMHI use. Finally, points that were identified as important to consider when developing DMHIs include offering encouragement throughout the DMHI, accommodating for individual and collective needs within DMHIs and developing a structure within the DMHI which includes adding in attainable goals.ConclusionsIf used, the information provided from this study can generate positive and productive PPI consultations where those with lived experience can make significant contributions to the development of DMHIs. Such contributions will increase the acceptability and efficacy of the DMHIs developed.Disclosure of InterestNone Declared

Physical Therapies for Delayed Onset Muscle Soreness: A Protocol for an Umbrella and Mapping Systematic Review with Meta-Meta-Analysis.

Delayed onset muscle soreness (DOMS), also known as exercise-induced muscle damage (EIMD), is typically caused by strenuous and/or unaccustomed physical exercise. DOMS/EIMD manifests itself in reduced muscle strength and performance levels, increased muscle soreness, swelling, and elevated levels of inflammatory biomarkers. Numerous randomised controlled trials (RCTs) and systematic reviews (SRs) of a wide variety of physiotherapy interventions for reducing the signs and symptoms of DOMS/EIMD have been published. However, these SRs often arrive at contradictory conclusions, impeding decision-making processes. We will systematically review the current evidence on clinical outcomes (efficacy, safety) of physiotherapy interventions for the treatment of DOMS/EIMD in healthy adults. We will also assess the quality of the evidence and identify, map, and summarise data from the available SRs. Umbrella review with evidence map and meta-meta-analyses. MEDLINE, Embase, Cochrane Database of Systematic Reviews, Epistemonikos and PEDro will be searched from January 1998 until February 2024. SRs of RCTs of any treatment used by physiotherapists (e.g., low-level laser therapy, electrical stimulation, heat/cold therapy, ultrasound, magnets, massage, manual therapies) to treat DOMS/EIMD in healthy adults will be eligible. Narrative/non-systematic reviews, studies of adolescents/children and medically compromised individuals, of complementary therapies, dietary, nutritional, or pharmacological interventions, as well as self-administered interventions, or those published before 1998, will be excluded. AMSTAR 2 will be used to evaluate the methodological quality of the included SRs. Corrected covered area, will be computed for assessing overlaps among included SRs, and an evidence map will be prepared to describe the credibility of evidence for interventions analysed in the relevant SRs. DOMS/EIMD is a complex condition, and there is no consensus regarding the standard of clinical/physiotherapeutic care. By critically evaluating the existing evidence, we aim to inform clinicians about the most promising therapies for DOMS/EIMD. This umbrella review has the potential to identify gaps in the existing evidence base that would inform future research. The protocol has been registered at PROSPERO (CRD42024485501].

Improving lexical retrieval with LingoTalk: an app-based, self-administered treatment for clients with aphasia

IntroductionLingoTalk is a German speech-language app designed to enhance lexical retrieval in individuals with aphasia. It incorporates automatic speech recognition (ASR) to provide therapist-independent feedback. The execution and effectiveness of a self-administered intervention with LingoTalk was explored in a case series study.MethodsThree individuals with chronic aphasia participated in a highly individualized, supervised self-administered intervention lasting 3 weeks. The LingoTalk app closely monitored the frequency, intensity and progress of the intervention. Treatment efficacy was assessed using a multiple baseline design, examining both item-specific treatment effects and generalization to untreated items, an untreated task, and spontaneous speech.ResultsAll participants successfully completed the intervention with LingoTalk, although one participant was not able to use the ASR feature. None of the participants fully adhered to the treatment protocol. All participants demonstrated significant and sustained improvement in the naming of practiced items, although there was limited evidence of generalization. Additionally, there was a slight reduction in word-finding difficulties during spontaneous speech.DiscussionThis small-scale study indicates that self-administered intervention with LingoTalk can improve oral naming of treated items. Thus, it has the potential to complement face-to-face speech-language therapy, such as within in a “flipped speech room” approach. The choice of feedback mode is discussed. Transparent progress monitoring of the intervention appears to positively influence patients' motivation.

Non-pharmacological interventions to manage psychological distress in patients living with cancer: a systematic review

BackgroundPsychological distress is common in patients with cancer; interfering with physical and psychological wellbeing, and hindering management of physical symptoms. Our aim was to systematically review published evidence on non-pharmacological interventions for cancer-related psychological distress, at all stages of the disease.MethodsWe followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The review was registered on PROSPERO (CRD42022311729). Searches were made using eight online databases to identify studies meeting our inclusion criteria.Data were collected on outcome measures, modes of delivery, resources and evidence of efficacy. A meta-analysis was planned if data allowed. Quality was assessed using the Mixed Methods Appraisal Tool (MMAT).ResultsFifty-nine studies with 17,628 participants were included. One third of studies included mindfulness, talking or group therapies. Half of all studies reported statistically significant improvements in distress. Statistically significant intervention effects on distress were most prevalent for mindfulness techniques. Four of these mindfulness studies had moderate effect sizes (d = -0.71[95% CI: -1.04, -0.37] p < 0.001) (d = -0.60 [95% CI: -3.44, -0.89] p < 0.001) (d = -0.77 [CI: -0.146, -1.954] p < 0.01) (d = -0.69 [CI: -0.18, -1.19] p = 0.008) and one had a large effect size (d = -1.03 [95% CI: -1.51, -0.54] p < 0.001). Heterogeneity of studies precluded meta-analysis. Study quality was variable and some had a high risk of bias.ConclusionsThe majority of studies using a mindfulness intervention in this review are efficacious at alleviating distress. Mindfulness—including brief, self-administered interventions—merits further investigation, using adequately powered, high-quality studies.Systematic review registrationThis systematic review is registered on PROSPERO, number CRD42022311729.

Using group-based interactive video teleconferencing to make self-compassion more accessible: A randomized controlled trial

ObjectiveMany interventions designed to increase self-compassion are either (1) intense, group-based, and face-to-face delivered programs, such as Mindful Self-Compassion, or (2) less intense, self-administered interventions, such as self-compassionate writing or following guided meditations. This study explores if self-compassion can be increased in a novel intervention that is both intense and accessible using online group-based interactive video teleconferencing. MethodOne-hundred-fifty-five healthy participants (130 women, 25 men) were randomized to a wait-list control group or to an intervention group that participated in two online workshops (via Zoom) and completed a self-compassionate writing exercise. Participants filled out the Self-Compassion Scale (SCS) before, directly after, and 1-week after the intervention. We assessed overall self-compassion, in addition to its six constituent subfactors: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. We analyzed all results using an intent-to-treat approach. In addition, participants’ impressions and feasibility of the intervention were assessed. ResultsUsing linear mixed models, we found that the intervention increased total self-compassion as indicated by a significant interaction of Time and Treatment, F(2, 203.38) = 5.47, p = .005, with a small-to-medium effect, f = 0.22. Contrasts indicated significant differences between the intervention and the control group at the 1-week follow-up, but not directly after the intervention. We found similar effects for self-kindness, common humanity, and isolation. Qualitative answers indicated that participants liked the intervention and were pleased with the opportunity to interact with other participants. ConclusionsSelf-compassion can be trained using interactive video teleconferencing interventions. The study highlights the potential benefits of group-based interventions as they allow for more interactions among participants, which in turn could reduce feelings of isolation. Finally, interactive video teleconferencing interventions have large unexplored potential for improving various resources that improve mental health or other facets of well-being other than self-compassion and this article gives recommendations for how to structure such interventions.

Preliminary Efficacy of Let's Talk Tech: Technology Use Planning for Dementia Care Dyads.

Care partners of people living with dementia require support to knowledgeably navigate decision making about how and when to use monitoring technologies for care purposes. We conducted a pilot study of a novel self-administered intervention, "Let's Talk Tech," for people living with mild dementia and their care partners. This paper presents preliminary efficacy findings of this intervention designed to educate and facilitate dyadic communication about a range of technologies used in dementia care and to document the preferences of the person living with dementia. It is the first-of-its-kind decision-making and planning tool with a specific focus on technology use. We used a 1-group pretest-post-test design and paired t tests to assess change over 2 time periods in measures of technology comprehension, care partner knowledge of the participant living with mild Alzheimer's disease's (AD) preferences, care partner preparedness to make decisions about technology use, and mutual understanding. Thematic analysis was conducted on postintervention interview transcripts to elucidate mechanisms and experiences with Let's Talk Tech. Twenty-nine mild AD dementia care dyads who live together completed the study. There was statistically significant improvement with medium and large effect sizes on outcome measures of care partners' understanding of each technology, care partners' perceptions of the person living with dementia's understanding of each technology, knowledge of the person living with dementia's preferences, decision-making preparedness, and care partners' feelings of mutual understanding. Participants reported that it helped them have important and meaningful conversations about using technology. Let's Talk Tech demonstrated promising preliminary efficacy on targeted measures that can lead to informed, shared decision making about technologies used in dementia care. Future studies should assess efficacy with larger samples and more diverse sample populations in terms of race, ethnicity, and dementia type.

Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial

BackgroundTranscranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. MethodsFEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a ‘washout’ period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. ResultsClinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = −0.5 [95% CI −1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. ConclusionstDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step.Trial registration: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049

Self-applied topical interventions for melasma: a systematic review and meta-analysis of data from randomized, investigator-blinded clinical trials.

Melasma is a common dermatological condition. Although its relevance as a skin condition is primarily of a cosmetic nature, it may affect the patient's wellbeing and quality of life. A broad range of treatment options is available, which makes it difficult to choose the most appropriate of those treatments. To summarize and critically appraise evidence from investigator-blinded randomized controlled trials (RCTs) on the efficacy and safety of self-applied topical interventions for melasma. We systematically searched MEDLINE and the Cochrane CENTRAL trials database for RCTs on topical, self-administered interventions for patients diagnosed with melasma. Eligibility was limited to RCTs that explicitly stated in their methods section (i) how they generated the random allocation sequence, and (ii) that the study outcome assessor was blinded to the participants' group allocation. Outcomes of interest included evaluator-assessed clinical scores (such as the Melasma Area and Severity Index), quality of life and patient-reported outcomes, as well as safety outcomes. The study findings were meta-analysed, pooling data from studies on the same comparisons, if this was possible. We assessed confidence in effect estimates using the GRADE approach. Our searches yielded 1078 hits. We included 36 studies reporting on 47 different comparisons of interventions. These included medical treatments such as 'triple combination cream' (TCC), over-the-counter cosmetic and herbal products, as well as sun creams covering different light spectra. Pooling data was possible for only two comparisons, topical tranexamic acid (TXA) vs. hydroquinone (HQ) and cysteamine vs. placebo. Direct comparisons were available for a variety of interventions; however, the reported outcomes varied greatly. Overall, our confidence in the effect estimates ranged from very low to high. Our findings indicate that TCC and its individual components HQ and tretinoin are effective in lightening melasma. Besides these established self-applied treatment options, we identified further medical treatments as well as promising cosmetic and herbal product treatment approaches. Furthermore, evidence suggests that using broad-spectrum sunscreen covering both the visible and ultraviolet-light spectrum enhances the treatment efficacy of HQ. However, with mostly small RCTs comparing treatments directly using a broad range of outcomes, further research is needed to draw conclusions about which treatment is most effective. What is already known about this topic? Melasma is a common dermatological disease. Although it is primarily a cosmetic condition, it can severely affect the patient's wellbeing and quality of life. Treatment options for melasma include a broad range of medical, cosmetic and herbal products. Given the large number of available interventions, it is difficult for clinicians and for patients to make informed decisions about which treatment to choose. What does this study add? We systematically assessed data from investigator-blinded randomized controlled trials of self-applied topical interventions. Our GRADE evaluations of confidence in the findings ranged from very low to high and may help clinicians and patients navigate treatment decisions. Besides the established self-applied medical treatment options, we identified promising cosmetic and herbal treatment approaches. Evidence suggests sunscreen covering the ultraviolet (UV)- and visible light spectra increases treatment efficacy compared with UV-only protection.

Self-help Digital Interventions Targeted at Improving Psychological Well-being in Young People With Perceived or Clinically Diagnosed Reduced Well-being: Systematic Review.

BackgroundLevels of well-being are declining, whereas rates of mental health problems remain high in young people. The World Health Organization defines mental health as not merely the absence of mental disorder but also includes social and psychological well-being as integral to positive mental health, highlighting that mental health is applicable to young people with mental health conditions and those without a diagnosis of a mental health condition. Reduced mental well-being have been identified in studies of young people with clinical populations, as well as in populations consisting of nonclinical young people. Self-help digital interventions can be delivered at mass at a low cost and without the need for trained input, thereby facilitating access to support for well-being. Self-help interventions are effective in young people with mental health conditions, but systematic reviews of such studies have been limited to randomized controlled trials, have not included reduced well-being as an inclusion criterion, and do not consider engagement factors such as retention.ObjectiveThe objective of this study was to systematically review all controlled studies of digitally delivered, self-administered interventions for young people aged 9 to 25 years, with perceived or clinically diagnosed reduced psychological well-being. Participant retention and effectiveness of the interventions were also explored.MethodsA systematic search of the PsycInfo, EMBASE, Cochrane, Scopus, and MEDLINE databases from inception to 2021, reference searches of relevant papers, and gray literature was carried out for digitally controlled studies conducted with young people with perceived or clinically diagnosed reduced well-being, aimed at improving psychological well-being. Data were extracted to identify the effectiveness and retention rates of the interventions and the quality of the studies.ResultsOverall, 1.04% (12/1153) of studies met the inclusion criteria: 83% (10/12) of studies were randomized controlled trials and 17% (2/12) were controlled pre-post studies. Most (6/12, 50%) studies aimed to improve symptoms of depression; 3 interventions aimed at both anxiety and depressive symptoms and 2 studies aimed at improving social functioning difficulties. Owing to the high risk of bias across interventions and lack of similar outcome measures, a meta-analysis was not conducted. Retention rates across studies were regarded as good, with moderate to high retention. Overall, the findings indicated that predominantly self-administered self-help interventions improved well-being in the areas targeted by the intervention and identified additional areas of well-being that were positively affected by interventions. Few interventions supported psychological well-being that was different from those used by young people with a clinical diagnosis of mental illness or young people from neurodiverse backgrounds.ConclusionsThe findings, along with the advantages of self-help interventions, highlight the need for upscaling self-help interventions to better support vulnerable populations of young people who experience poor psychological well-being.Trial RegistrationPROSPERO CRD42019129321; https://tinyurl.com/4fb2t4fz

Evaluating the Efficacy of a Smartphone App for Tinnitus Relief Using Behavioral and Brain Imaging Measures.

In this exploratory, open-label study, we used behavioral and brain imaging measures to assess the effectiveness of a smartphone application (ReSound Relief app), which aims to help reduce tinnitus-related distress. Fourteen participants with a wide range of tinnitus-related symptoms and who were not currently undergoing any external treatment participated. They completed the 6-month study and reported different levels of engagement with the app. Across a range of tinnitus questionnaires, most participants showed either no change or decrease in tinnitus handicap. Resting-state and task-based functional magnetic resonance imaging (fMRI) data were collected at baseline and the end of the study. Resting-state fMRI of 12 participants revealed alterations in interregional connectivity of default mode, salience, emotion, auditory, and visual processing networks at the end of the intervention period compared to baseline. Ratings of affective sounds (as pleasant, neutral, or unpleasant) were assessed using fMRI, and comparison after 6 months of app usage revealed reduced activity in the left superior temporal gyrus (secondary auditory cortex), right superior occipital gyrus, and left posterior cingulate cortex. Our findings were not significant at a false discovery rate level of p < .05. The reported changes were not significant, possibly due to the small sample size, heterogeneity of the tinnitus handicap among subjects at the start of the project, and the length of the intervention period. Nevertheless, this study underscores the ease of usage of the app and the potential use of brain imaging to assess changes due to a passive, self-administered intervention for individuals with varying levels of tinnitus severity.

Randomized trial of a self-administered parenting intervention for selective eating in young children

Selective eating is a common childhood feeding problem associated with family stress and micronutrient deficiencies. While there are empirically-supported behavioral strategies for addressing selective eating, there are significant systems-level barriers to implementing them. The aim of this study was to develop and test a self-administered intervention for parents of children with selective eating. Participants were 156 parents of children with selective eating ages 18 months-6 years who were randomly assigned to either the handout + video condition (8-module video intervention and detailed handout) or handout condition (detailed handout only). Outcome measures were administered pre-intervention and 4 weeks post-intervention. Only 23 % of participants in the handouts plus video condition played more than one video module. Both groups had significant decreases in maladaptive mealtime parenting practices, undesired child mealtime behaviors, and number of foods offered. No significant effect of study condition was found on the outcome measures. Further research is needed to determine how to encourage engagement of parents with self-administered intervention materials.