Self-guided Intervention Research Articles

Reducing HIV-related stigma and discrimination in healthcare settings: A systematic review of quantitative evidence.

IntroductionStigma and discrimination (SAD) related to HIV compromise access and adherence to treatment and support programs among people living with HIV (PLHIV). The ambitious goal of ending the epidemic of HIV by 2030 set by the United Nations Joint Program of HIV/AIDS (UNAIDS) will thus only be achieved if HIV-related stigma and discrimination are reduced. The objective of this review was to locate, appraise and describe international literature reporting on interventions that addressed HIV-related SAD in healthcare settings.MethodsThe databases searched were: Cumulative Index to Nursing and Allied Health (CINAHL), Excerpta Medica Database from Elsevier (EMBASE), PubMed and Psychological Information (PsycINFO) database. Two individuals independently appraised the quality of the papers using appraisal instruments from the Joanna Briggs Institute (JBI). Data were extracted from papers included in the review using the standardized data extraction tool from JBI. Quality of evidence for major outcomes was assessed using Grading of Recommendations, Assessment, Development and Evaluation (GRADE).ResultsWe retained 14 records reporting on eight studies. Five categories of SAD reduction (information-based, skills building, structural, contact-based and biomedical interventions) were identified. Training popular opinion leaders (POLs) resulted in significantly lower mean avoidance intent scores (MD = -1.87 [95% CI -2.05 to -1.69]), mean prejudicial attitude scores (MD = -3.77 [95% CI -5.4 to -2.09]) and significantly higher scores in mean compliance to universal precaution (MD = 1.65 [95% CI 1.41 to 1.89]) when compared to usual care (moderate quality evidence). The Summary of Findings table (SOF) is shown in Table 1.ConclusionsEvidence of moderate quality indicates that training popular opinion leaders is effective in reducing avoidance intent and prejudicial attitude and improving compliance to universal precaution. Very low quality evidence indicates that professionally-assisted peer group interventions, modular interactive training, participatory self-guided assessment and intervention, contact strategy combined with information giving and empowerment are effective in reducing HIV-related stigma.Further Randomized Controlled Trials (RCTs) are needed. Future trials need to use up-to-date and validated instruments to measure stigma and discrimination.

A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial

BackgroundOnly a small fraction of individuals with pathological or problematic gambling seek professional help despite available evidence-based treatments such as cognitive behavioral therapy (CBT). Anonymous Internet-based interventions may help to overcome treatment barriers. Results of a pilot study using an Internet-based intervention for depression in a sample of individuals with problematic or pathological gambling behavior show that both depressive and gambling-related symptomatology can be reduced with a generic depression program compared with a wait-list control group. Based on encouraging results of the pilot study, we developed a low-threshold, anonymous and cost-free online self-help program (“Restart”) to test whether a program tailored to the needs of gamblers yields better results compared to the effects of the intervention evaluated in the pilot study. The online self-help program is based on CBT, targeting emotional problems and gambling-related symptoms and is accompanied by a smartphone application to sustain treatment benefits.MethodA randomized controlled trial with two conditions (intervention group and wait-list control group), two assessment times (reassessment after 8 weeks) and a total of 136 participants is planned. The primary outcome will be change in pathological gambling measured with the Pathological Gambling Adaptation of Yale-Brown Obsessive-Compulsive Scale from pre to post intervention. The change in depressive symptoms (assessed with the Patient Health Questionnaire - 9 depression module) and gambling-related dysfunctional thoughts (assessed with the Gambling Attitudes and Beliefs Survey) will represent secondary outcomes. The intervention includes modules on debt management, impulse control, gambling-specific cognitive biases, self-esteem, social competence, sleep hygiene, mindfulness and positive activities.DiscussionThis study is one of the first investigations of Internet-based self-help programs in a sample of problematic gamblers. Self-guided Internet-based interventions represent a promising possibility to narrow the existing treatment gap while saving expensive and scarce resources (e.g., psychotherapists). The expected findings will add substantial knowledge in the development of effective Internet-based treatments for individuals with gambling problems. The empirical and clinical implications (e.g., broader use and promotion of such interventions in the future) and the limitations of the study will be discussed.Trial registrationClinicalTrials.gov, NCT03372226. Registered on 13 December 2017.

A web-based self-guided program to promote valued-living in college students: A pilot study

Web-based programs that focus on values, a core process within acceptance and commitment therapy (ACT), may be a promising approach to cultivate positive psychosocial adjustment among undergraduates. The current study tested the usability, acceptability, and receptivity of the Living Your Values (LYV) program, a single-session, web-delivered, self-guided values intervention for undergraduates and its utility to promote valued-living and psychological well-being. In an undergraduate sample (N = 133), while the LYV program was deemed moderately usable, acceptability and receptivity findings were more attenuated. At follow-up (n = 98), a significant pre-intervention to follow-up increase in valued-living was evidenced both overall and for leisure/recreation/community/citizenship values. No significant changes in psychological well-being were demonstrated. Further program development considerations are discussed.

Examining Predictors of Real-World User Engagement with Self-Guided eHealth Interventions: Analysis of Mobile Apps and Websites Using a Novel Dataset.

BackgroundThe literature suggests that the product design of self-guided electronic health (eHealth) interventions impacts user engagement. Traditional trial settings, however, do not enable the examination of these relationships in real-world use.ObjectiveThis study aimed to examine whether the qualities of product design, research evidence, and publicly available data predict real-world user engagement with mobile and Web-based self-guided eHealth interventions.MethodsThis analysis included self-guided mobile and Web-based eHealth interventions available to the public—with their qualities assessed using the Enlight suite of scales. Scales included Usability, Visual Design, User Engagement, Content, Therapeutic Persuasiveness, Therapeutic Alliance, Credibility, and Research Evidence. Behavioral data on real-world usage were obtained from a panel that provides aggregated nonpersonal information on user engagement with websites and mobile apps, based on a time window of 18 months that was set between November 1, 2016 and April 30, 2018. Real-world user engagement variables included average usage time (for both mobile apps and websites) and mobile app user retention 30 days after download.ResultsThe analysis included 52 mobile apps (downloads median 38,600; interquartile range [IQR] 116,000) and 32 websites (monthly unique visitors median 5689; IQR 30,038). Results point to moderate correlations between Therapeutic Persuasiveness, Therapeutic Alliance, and the 3 user engagement variables (.31≤rs≤.51; Ps≤.03). Visual Design, User Engagement, and Content demonstrated similar degrees of correlation with mobile app engagement variables (.25≤rs≤.49; Ps≤.04) but not with average usage time of Web-based interventions. Positive correlations were also found between the number of reviews on Google Play and average app usage time (r=.58; P<.001) and user retention after 30 days (r=.23; P=.049). Although several product quality ratings were positively correlated with research evidence, the latter was not significantly correlated with real-world user engagement. Hierarchical stepwise regression analysis revealed that either Therapeutic Persuasiveness or Therapeutic Alliance explained 15% to 26% of user engagement variance. Data on Google Play (number of reviews) explained 15% of the variance of mobile app usage time above Enlight ratings; however, publicly available data did not significantly contribute to explaining the variance of the other 2 user-engagement variables.ConclusionsResults indicate that the qualities of product design predict real-world user engagement with eHealth interventions. The use of real-world behavioral datasets is a novel way to learn about user behaviors, creating new avenues for eHealth intervention research.

Development of a self-guided web-based intervention to promote physical activity using the multi-process action control framework

PurposePhysical activity promotion has mostly focused on theories of intention-formation, with the assumption that positive intentions will lead to behaviour. Though necessary, exercise intentions alone are often not sufficient to improve physical activity behaviour. The Multi-Process Action Control (M-PAC) framework builds on previous intention-based theories by including both determinants of intention formation and its translation into behaviour. The purpose of this study was to describe the process of developing a self-guided web-based intervention to promote physical activity among adults using the M-PAC model. ProceduresThe development process consisted of the following three phases: 1) Intervention planning: determine intervention needs and requirements; 2) Intervention development: use an iterative process to design a web-based physical activity intervention based on the M-PAC framework; 3) Pilot testing: conduct usability and acceptability assessment on the web-based intervention to further enhance user experience. Principal resultsThe intervention planning phase suggested that there is a need for web-based physical activity interventions and there is currently no web-based intervention designed using the M-PAC model. In phase two, we adopted an iterative process to develop a 10-week self-guided web-based intervention to help adults (>18 years of age) to meet 150 min of moderate to vigorous physical activity per week. The pilot testing phase yielded valuable feedback on usability, content, and design of the web-based intervention. Major conclusionsThe development of a web-based physical activity intervention using the M-PAC model could further enhance the effectiveness of web-based interventions and have a significant impact on extending the reach of existing physical activity promotion programs. This study has reinforced the importance of an iterative development process that involves a multi-disciplinary team to design a web-based intervention to promote physical activity. The process enabled the team to clarify the needs for an intervention for our target users, and provided valuable feedback on the design and content of the web-based intervention. Future studies are now needed to evaluate the effectiveness of our web-based intervention.

A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma.

This study assessed the feasibility and acceptability of an online mindfulness-based intervention (MBI) for people diagnosed with melanoma. The potential benefit of the MBI on fear of cancer recurrence (FCR), worry, rumination, perceived stress and trait mindfulness was also explored. Participants who have completed treatment for stage 2c or 3 melanoma were recruited from an outpatient clinic and randomly allocated to either the online MBI (intervention) or usual care (control). The 6-week online MBI comprised short videos, daily guided meditations and automated email reminders. Participants were asked to complete questionnaires at baseline and at 6-week post-randomisation. Study feasibility and acceptability were assessed through recruitment rates, retention and participant feedback. Clinical and psychosocial outcomes were compared between groups using linear mixed models. Sixty-nine (58%) eligible participants were randomised (46 in the intervention; 23 in the control group); mean age was 53.4 (SD 13.1); 54% were female. Study completion rate across both arms was 80%. The intervention was found helpful by 72% of the 32 respondents. The intervention significantly reduced the severity of FCR compared to the control group (mean difference = - 2.55; 95% CI - 4.43, - 0.67; p = 0.008). There was no difference between the intervention and control groups on any of the outcome measures. This online MBI was feasible and acceptable by people at high risk of melanoma recurrence. It significantly reduced FCR severity in this sample. Patients valued accessing the program at their own pace and convenience. This self-guided intervention has the potential to help survivors cope with emotional difficulties. An adequately powered randomised controlled trial to test study findings is warranted.

Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.

This multicentre randomised controlled trial examined the efficacy of Finding My Way (FMW), a 6-week/6-module online self-guided psychotherapeutic intervention for newly diagnosed curatively treated cancer survivors, in reducing cancer-related distress and improving quality of life compared to an online attention control. Participants were randomised on a 1:1 ratio using a gender-stratified block design to intervention (n = 94) or attention control (n = 97), and were blinded to condition. Assessments were completed at baseline (T0), post-intervention (T1), 3months (T2), and 6months (T3) post-intervention. Mixed model repeated measures analyses examined differences between groups for cancer-specific distress (primary outcome) and general distress, quality of life (QoL), coping, and health service utilisation (secondary outcomes). While both groups reported reduced cancer-specific and general distress over time, between-group differences were not significant. Intervention participants reported lower total health service utilisation and supportive care utilisation post-intervention than controls (total HS use: between-group mean difference = - 1.07 (- 1.85 to - 0.28); supportive care use: between-group mean difference = - 0.64 (- 1.21 to - 0.06)) and significantly higher emotional functioning at 3months (between-group mean difference = 7.04 (0.15 to 13.9)). At 6months, the supportive care utilisation finding reversed (between-group mean difference = 0.78 points (0.19 to 1.37). Across remaining QoL and coping outcomes, no significant group differences emerged. While both groups experienced reductions in distress, between-group differences were not significant. This contrasts with the significantly improved emotional functioning observed in FMW participants at 3months and the short-term reductions in health service utilisation. Long-term increases in supportive care service utilisation suggest FMW only met needs while being actively used. ACTRN12613000001796; http://www.ANZCTR.org.au/ACTRN12613000001796.aspx.

Examining the Effectiveness of Two Types of Forgiveness Intervention to Enhance Well-Being in Adults from Young to Older Adulthood

Background: The present study examined the efficacy of two self-guided interventions, which aimed at enhancing adults’ wellbeing through the cultivation of forgiveness skills. Methods: A total of 11 men and 31 women aged 34-80 years were involved (M = 56.57, S.D. = 13.44). The participants were asked to complete questionnaires measuring the sense of wellbeing, the trait of forgiveness, and avoidance, revenge, and benevolence motivations. Subsequently, they were randomly divided into two groups which were matched in age, gender and educational level, and one group followed the General (n = 22), and the other one the Orthodox-Tradition-Enhanced Intervention (n = 20). The two interventions included six steps towards forgiveness. For their completion a combination of individual sessions and a personal study were implemented. The process was completed in one week. Participants were also asked to complete the same questionnaires immediately after the intervention as well as two weeks after the intervention (follow-up measurement). Results: The results showed that forgiveness skills and subjective wellbeing were strengthened via both interventions and significantly more in the Orthodox. The primacy of the Orthodox approach has been demonstrated to reduce negative emotions and to promote a sense of wellbeing over time. Possible mechanisms for the effectiveness of the intervention are discussed. Conclusions: The findings are promising for the ability of forgiveness interventions, and especially of that based on the Orthodox tradition, to improve the forgiving skills and increase mental wellbeing in adults.

A Mobile App-Based Intervention for Depression: End-User and Expert Usability Testing Study.

BackgroundDespite the growing number of mental health apps available for smartphones, the perceived usability of these apps from the perspectives of end users or health care experts has rarely been reported. This information is vital, particularly for self-guided mHealth interventions, as perceptions of navigability and quality of content are likely to impact participant engagement and treatment compliance.ObjectiveThe aim of this study was to conduct a usability evaluation of a personalized, self-guided, app-based intervention for depression.MethodsParticipants were administered the System Usability Scale and open-ended questions as part of a semistructured interview. There were 15 participants equally divided into 3 groups: (1) individuals with clinical depression who were the target audience for the app, (2) mental health professionals, and (3) researchers who specialize in the area of eHealth interventions and/or depression research.ResultsThe end-user group rated the app highly, both in quantitative and qualitative assessments. The 2 expert groups highlighted the self-monitoring features and range of established psychological treatment options (such as behavioral activation and cognitive restructuring) but had concerns that the amount and layout of content may be difficult for end users to navigate in a self-directed fashion. The end-user data did not confirm these concerns.ConclusionsEncouraging participant engagement via self-monitoring and feedback, as well as personalized messaging, may be a viable way to maintain participation in self-guided interventions. Further evaluation is necessary to determine whether levels of engagement with these features enhance treatment effects.

Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review.

BackgroundInternet-supported mindfulness-based interventions (MBIs) are increasingly being used to support people with a chronic condition. Characteristics of MBIs vary greatly in their mode of delivery, communication patterns, level of facilitator involvement, intervention period, and resource intensity, making it difficult to compare how individual digital features may optimize intervention adherence and outcomes.ObjectiveThe aims of this review were to (1) provide a description of digital characteristics of internet-supported MBIs and examine how these relate to evidence for efficacy and adherence to the intervention and (2) gain insights into the type of information available to inform translation of internet-supported MBIs to applied settings.MethodsMEDLINE Complete, PsycINFO, and CINAHL databases were searched for studies assessing an MBI delivered or accessed via the internet and engaging participants in daily mindfulness-based activities such as mindfulness meditations and informal mindfulness practices. Only studies using a comparison group of alternative interventions (active compactor), usual care, or wait-list were included. Given the broad definition of chronic conditions, specific conditions were not included in the original search to maximize results. The search resulted in 958 articles, from which 11 articles describing 10 interventions met the inclusion criteria.ResultsInternet-supported MBIs were more effective than usual care or wait-list groups, and self-guided interventions were as effective as facilitator-guided interventions. Findings were informed mainly by female participants. Adherence to interventions was inconsistently defined and prevented robust comparison between studies. Reporting of factors associated with intervention dissemination, such as population representativeness, program adoption and maintenance, and costs, was rare.ConclusionsMore comprehensive descriptions of digital characteristics need to be reported to further our understanding of features that may influence engagement and behavior change and to improve the reproducibility of MBIs. Gender differences in determinants and patterns of health behavior should be taken into account at the intervention design stage to accommodate male and female preferences. Future research could compare MBIs with established evidence-based therapies to identify the population groups that would benefit most from internet-supported programs.Trial RegistrationPROSPERO CRD42017078665; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=78665 (Archived by WebCite at http://www.webcitation.org/71ountJpu)

Using Mobile Apps to Assess and Treat Depression in Hispanic and Latino Populations: Fully Remote Randomized Clinical Trial.

BackgroundMost people with mental health disorders fail to receive timely access to adequate care. US Hispanic/Latino individuals are particularly underrepresented in mental health care and are historically a very difficult population to recruit into clinical trials; however, they have increasing access to mobile technology, with over 75% owning a smartphone. This technology has the potential to overcome known barriers to accessing and utilizing traditional assessment and treatment approaches.ObjectiveThis study aimed to compare recruitment and engagement in a fully remote trial of individuals with depression who either self-identify as Hispanic/Latino or not. A secondary aim was to assess treatment outcomes in these individuals using three different self-guided mobile apps: iPST (based on evidence-based therapeutic principles from problem-solving therapy, PST), Project Evolution (EVO; a cognitive training app based on cognitive neuroscience principles), and health tips (a health information app that served as an information control).MethodsWe recruited Spanish and English speaking participants through social media platforms, internet-based advertisements, and traditional fliers in select locations in each state across the United States. Assessment and self-guided treatment was conducted on each participant's smartphone or tablet. We enrolled 389 Hispanic/Latino and 637 non-Hispanic/Latino adults with mild to moderate depression as determined by Patient Health Questionnaire-9 (PHQ-9) score≥5 or related functional impairment. Participants were first asked about their preferences among the three apps and then randomized to their top two choices. Outcomes were depressive symptom severity (measured using PHQ-9) and functional impairment (assessed with Sheehan Disability Scale), collected over 3 months. Engagement in the study was assessed based on the number of times participants completed active surveys.ResultsWe screened 4502 participants and enrolled 1040 participants from throughout the United States over 6 months, yielding a sample of 348 active users. Long-term engagement surfaced as a key issue among Hispanic/Latino participants, who dropped from the study 2 weeks earlier than their non-Hispanic/Latino counterparts (P<.02). No significant differences were observed for treatment outcomes between those identifying as Hispanic/Latino or not. Although depressive symptoms improved (beta=–2.66, P=.006) over the treatment course, outcomes did not vary by treatment app.ConclusionsFully remote mobile-based studies can attract a diverse participant pool including people from traditionally underserved communities in mental health care and research (here, Hispanic/Latino individuals). However, keeping participants engaged in this type of “low-touch” research study remains challenging. Hispanic/Latino populations may be less willing to use mobile apps for assessing and managing depression. Future research endeavors should use a user-centered design to determine the role of mobile apps in the assessment and treatment of depression for this population, app features they would be interested in using, and strategies for long-term engagement.Trial RegistrationClinicaltrials.gov NCT01808976; https://clinicaltrials.gov/ct2/show/NCT01808976 (Archived by WebCite at http://www.webcitation.org/70xI3ILkz)

Towards a framework for reporting self-guided interventions for people with cancer.

The purpose of this article is to provide an updated review exploring the recent developments in the field of self-guided interventions and describe the state of knowledge. This article builds on a previous systematic review on self-guided interventions, finding that the recent literature demonstrates that evidence for these interventions is mixed. The field is limited by descriptions of these interventions, and it is not possible to ascertain what aspects of interventions are more successful. Development of a reporting framework whereby self-guided interventions could be clearly presented, would be a substantial contribution to understanding the evidence for these studies. Recent findings also support the need to understand patient adherence and engagement, which could be achieved within a reporting framework. Additionally, ensuring patient safety is paramount and all studies should develop strategies to ensure patients can engage with these studies in a way that allows them to access more help and support if required. Self-guided interventions have potential for implementation and further translation because of being cost-effective and requiring few resources; and a reporting framework has the capacity to lead to clearer definitions and descriptions; and significantly improve the quality of evidence for these studies.

A randomized controlled trial of MoodSwings 2.0: An internet-based self-management program for bipolar disorder.

MoodSwings 2.0 is an online self-guided intervention for bipolar disorder that includes educational modules, interactive tools, and discussion forums. The primary aim of the study was to determine if participation in MoodSwings 2.0 would result in decreased symptoms of depression and mania compared to the control condition. Secondary aims were to identify improvements in core depression symptoms, quality of life, medication adherence, functioning, and time to relapse. This was a three-arm randomized controlled trial that compared two intervention arms against a peer support control group (forum). A total of 304 adults aged 21 to 65 years with a diagnosis of bipolar disorder were assigned to a forum-only control group (Group 1; n=102), a forum plus modules treatment group (Group 2; n=102), or a forum, modules, and tools treatment group (Group 3; n=100), in addition to usual care. There was a significant intervention impact showing improvement on the primary outcome of depression for Group 2 compared to Group 1 (P=.05) with effect sizes (Cohen's d) ranging from 0.17 to 0.43. There was also a significant intervention impact showing improvement on the secondary outcome of core depression for Group 2 (P=.02) and Group 3 (P=.05), but worse physical functioning for Group 3 (P=.01), compared to Group 1. This study provides evidence of the efficacy of internet-based psychoeducation interventions for bipolar disorder in reducing depressive symptoms. Further investigation is needed to assess effectiveness in a public program.

Quantitative and qualitative testing of DARWeb: An online self-guided intervention for children with functional abdominal pain and their parents.

The main objective of this study was to preliminary explore the effects of DARWeb on different outcomes. A Quasi-experimental, one-group, pretest-posttest design was used. Parents and children were asked to complete questionnaires and questions (separately) about quality of life, abdominal pain severity, and satisfaction. Semi-structured interviews with families were also performed. This study focuses on 17 families. Results showed that parent's ratings of children's abdominal pain severity were significantly lower after finishing the intervention and at the 3-month follow-up, and quality of life scores had increased significantly after 3 months. From children's ratings, mean abdominal pain severity scores were significantly lower after the intervention compared to the preintervention assessment. Both parents and children were quite satisfied with the intervention. In qualitative interviews, families suggested that DARWeb helped them to give less importance to pain and to learn coping strategies. In conclusion, this study showed the potential usefulness of DARWeb for children with functional abdominal pain and for their parents.

Internet- and Mobile-Based Psychological Interventions: Applications, Efficacy, and Potential for Improving Mental Health

Abstract. The majority of mental health disorders remain untreated. Many limitations of traditional psychological interventions such as limited availability of evidence-based interventions and clinicians could potentially be overcome by providing Internet- and mobile-based psychological interventions (IMIs). This paper is a report of the Taskforce E-Health of the European Federation of Psychologists’ Association and will provide an introduction to the subject, discusses areas of application, and reviews the current evidence regarding the efficacy of IMIs for the prevention and treatment of mental disorders. Meta-analyses based on randomized trials clearly indicate that therapist-guided stand-alone IMIs can result in meaningful benefits for a range of indications including, for example, depression, anxiety, insomnia, or posttraumatic stress disorders. The clinical significance of results of purely self-guided interventions is for many disorders less clear, especially with regard to effects under routine care conditions. Studies on the prevention of mental health disorders (MHD) are promising. Blended concepts, combining traditional face-to-face approaches with Internet- and mobile-based elements might have the potential of increasing the effects of psychological interventions on the one hand or to reduce costs of mental health treatments on the other hand. We also discuss mechanisms of change and the role of the therapist in such approaches, contraindications, potential limitations, and risk involved with IMIs, briefly review the status of the implementation into routine health care across Europe, and discuss confidentiality as well as ethical aspects that need to be taken into account, when implementing IMIs. Internet- and mobile-based psychological interventions have high potential for improving mental health and should be implemented more widely in routine care.

Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

BackgroundPostpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa).ObjectiveThis study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety.MethodsPostpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility.ResultsA total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed iWaWa’s accessibility, anonymity, and weekly reminders, as well as the introduction to the principles of cognitive-behavioral therapy (CBT) and mindfulness. However, iWaWa was also experienced as not user-friendly enough, too long, and not smartphone-friendly. Parts of the content were experienced as not always relevant and appropriate. Participants felt that iWaWa could be improved by having it in a smartphone app format and by making the content more concise and inclusive of different parenting styles.ConclusionsDespite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa’s future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence.Trial RegistrationClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd)

Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis

ObjectiveFatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited.Here, we tested the effectiveness of a self-guided , interactive, online fatigue...

Physiotherapy breathing retraining for asthma: a randomised controlled trial

SummaryBackgroundDespite effective pharmacotherapy, asthma continues to impair quality of life for most patients. Non-pharmacological approaches, including breathing retraining, are therefore of great interest to patients. However, clinicians rarely advocate breathing retraining and access to this intervention is restricted for most patients due to the limited availability of suitable physiotherapists and poor integration of breathing retraining into standard care. We aimed to assess the effectiveness of a digital self-guided breathing retraining intervention.MethodsIn this randomised controlled trial, we recruited patients from 34 general practices in the UK. Eligibility criteria for patients with asthma were broad, comprising a physician diagnosis of asthma, age of 16–70 years, receipt of at least one anti-asthma medication in the previous year, and impaired asthma-related quality of life (Asthma Quality of Life Questionnaire [AQLQ] score of <5·5). We developed a self-guided intervention, which was delivered as a DVD plus a printed booklet (DVDB). Participants were randomly assigned to receive either the DVDB intervention, three face-to-face breathing retraining sessions, or standard care, in a 2:1:2 ratio, for 12 months. Randomisation was achieved using the Southampton Clinical Trials Unit telephone randomisation service by use of random number generators. The primary outcome was the AQLQ score in the intention-to-treat population at 12 months. The trial was powered to show equivalence between the two active intervention groups, and superiority of both intervention groups over usual care. Secondary outcomes included patient-reported and physiological measures of asthma control, patient acceptability, and health-care costs. This trial was registered with International Standard Randomised Controlled Trial Number registry, number ISRCTN88318003.FindingsBetween Nov 5, 2012 and Jan 28, 2014, invitations to participate in the study were sent to 15 203 patients with general practitioner-diagnosed asthma, of whom 655 were recruited into the study. AQLQ scores at 12 months were significantly higher in the DVDB group (mean 5·40, SD 1·14) than in the usual care group (5·12, SD 1·17; adjusted mean difference 0·28, 95% CI 0·11 to 0·44), and in the face-to-face group (5·33, SD 1·06) than in the usual care group (adjusted mean difference 0·24, 95% CI 0·04 to 0·44); AQLQ scores were similar between the DVDB group and the face-to-face group (0·04, 95% CI −0·16 to 0·24). There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide. 744 adverse events occurred in 272 patients: 101 (39%) of 261 patients in the DVDB group, 55 (42%) of 132 patients in the face-to-face group, and 132 (50%) of 262 in the usual care group, with patients reporting one or more event. 11 (4%) patients in the DVDB group, four (3%) patients in the face-to-face group, and 20 (8%) patients in the usual care group had a serious adverse event.InterpretationBreathing retraining programmes improve quality of life in patients with incompletely controlled asthma despite having little effect on lung function or airway inflammation. Such programmes can be delivered conveniently and cost-effectively as a self-guided digital audiovisual programme, so might also reduce health-care costs.FundingUK National Institute of Health Research.

Two Novel Cognitive Behavioral Therapy–Based Mobile Apps for Agoraphobia: Randomized Controlled Trial

BackgroundDespite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions.ObjectiveThe objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety.MethodsA Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale.ResultsBoth groups had statistically significant improvements in symptom severity over time (difference –5.97, 95% CI –8.49 to –3.44, P<.001 for Agoraphobia Free and –6.35, 95% CI –8.82 to –3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI –1.96 to 3.20, P=.64).ConclusionsThis is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw)

Self-Guided Web-Based Interventions: Scoping Review on User Needs and the Potential of Embodied Conversational Agents to Address Them.

BackgroundWeb-based mental health interventions have evolved from innovative prototypes to evidence-based and clinically applied solutions for mental diseases such as depression and anxiety. Open-access, self-guided types of these solutions hold the promise of reaching and treating a large population at a reasonable cost. However, a considerable factor that currently hinders the effectiveness of these self-guided Web-based interventions is the high level of nonadherence. The absence of a human caregiver apparently has a negative effect on user adherence. It is unknown to what extent this human support can be handed over to the technology of the intervention to mitigate this negative effect.ObjectiveThe first objective of this paper was to explore what is known in literature about what support a user needs to stay motivated and engaged in an electronic health (eHealth) intervention that requires repeated use. The second objective was to explore the current potential of embodied conversational agents (ECAs) to provide this support.MethodsThis study reviews and interprets the available literature on (1) support within eHealth interventions that require repeated use and (2) the potential of ECAs by means of a scoping review. The rationale for choosing a scoping review is that the subject is broad, diverse, and largely unexplored. Themes for (1) and (2) were proposed based on grounded theory and mapped on each other to find relationships.ResultsThe results of the first part of this study suggest the presence of user needs that largely remain implicit and unaddressed. These support needs can be categorized as task-related support and emotion-related support. The results of the second part of this study suggest that ECAs are capable of engaging and motivating users of information technology applications in the domains of learning and behavioral change. Longitudinal studies must be conducted to determine under what circumstances ECAs can create and maintain a productive user relationship. Mapping the user needs on the ECAs’ capabilities suggests that different kinds of ECAs may provide different solutions for improving the adherence levels.ConclusionsAutonomous ECAs that do not respond to a user’s expressed emotion in real time but take on empathic roles may be sufficient to motivate users to some extent. It is unclear whether those types of ECAs are competent enough and create sufficient believability among users to address the user’s deeper needs for support and empathy. Responsive ECAs may offer a better solution. However, at present, most of these ECAs have difficulties to assess a user’s emotional state in real time during an open dialogue. By conducting future research with relationship theory–based ECAs, the added value of ECAs toward user needs can be better understood.