Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework.

Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED). Designed for real-world use, the Evidence DEFINED Quick Start Guide may help streamline DHI assessment. A checklist is provided summarizing high-priority evidence considerations in digital health. Evidence-to-recommendation guidelines are proposed, specifying degrees of adoption that may be appropriate for a range of evidence quality levels. Evidence DEFINED differs from prior frameworks in its inclusion of unique elements designed for rigor and speed. Rigor is increased by addressing three gaps in prior frameworks. First, prior frameworks are not adapted adequately to address evidence considerations that are unique to digital health. Second, prior frameworks do not specify evidence quality criteria requiring increased vigilance for DHIs in the current regulatory context. Third, extant frameworks rarely leverage established, robust methodologies that were developed for non-digital interventions. Speed is achieved in the Evidence DEFINED Framework through screening optimization and deprioritization of steps that may have limited value. The primary goals of Evidence DEFINED are to a) facilitate standardized, rapid, rigorous DHI evidence assessment in organizations and b) guide digital health solutions providers who wish to generate evidence that drives DHI adoption.

Behavior science in the evolving world of digital health: considerations on anticipated opportunities and challenges.

Digital health promises to increase intervention reach and effectiveness for a range of behavioral health outcomes. Behavioral scientists have a unique opportunity to infuse their expertise in all phases of a digital health intervention, from design to implementation. The aim of this study was to assess behavioral scientists' interests and needs with respect to digital health endeavors, as well as gather expert insight into the role of behavioral science in the evolution of digital health. The study used a two-phased approach: (a) a survey of behavioral scientists' current needs and interests with respect to digital health endeavors (n = 346); (b) a series of interviews with digital health stakeholders for their expert insight on the evolution of the health field (n = 15). In terms of current needs and interests, the large majority of surveyed behavioral scientists (77%) already participate in digital health projects, and from those who have not done so yet, the majority (65%) reported intending to do so in the future. In terms of the expected evolution of the digital health field, interviewed stakeholders anticipated a number of changes, from overall landscape changes through evolving models of reimbursement to more significant oversight and regulations. These findings provide a timely insight into behavioral scientists' current needs, barriers, and attitudes toward the use of technology in health care and public health. Results might also highlight the areas where behavioral scientists can leverage their expertise to both enhance digital health's potential to improve health, as well as to prevent the potential unintended consequences that can emerge from scaling the use of technology in health care.

An iterative, interdisciplinary, collaborative framework for developing and evaluating digital behavior change interventions.

The rapid expansion of technology promises to transform the behavior science field by revolutionizing the ways in which individuals can monitor and improve their health behaviors. To fully live into this promise, the behavior science field must address distinct challenges, including: building interventions that are not only scientifically sound but also engaging; using evaluation methods to precisely assess intervention components for intervention optimization; and building personalized interventions that acknowledge and adapt to the dynamic ecosystem of individual and contextual variables that impact behavior change. The purpose of this paper is to provide a framework to address these challenges by leveraging behavior science, human-centered design, and data science expertise throughout the cycle of developing and evaluating digital behavior change interventions (DBCIs). To define this framework, we reviewed current models and practices for intervention development and evaluation, as well as technology industry models for product development. The framework promotes an iterative process, aiming to maximize outcomes by incorporating faster and more frequent testing cycles into the lifecycle of a DBCI. Within the framework provided, we describe each phase, from development to evaluation, to discuss the optimal practices, necessary stakeholders, and proposed evaluation methods. The proposed framework may inform practices in both academia and industry, as well as highlight the need to offer collaborative platforms to ensure successful partnerships that can lead to more effective DBCIs that reach broad and diverse populations.

Interest and Attitudes about Hypnosis in a Large Community Sample.

Despite the available empirical evidence supporting the efficacy of hypnosis for alleviating symptoms and side effects across a variety of clinical contexts, hypnosis has failed to disseminate widely. One way to try to better understand the lack of hypnosis dissemination is to apply a marketing theory approach, focusing on attitudes and beliefs about a product (hypnosis) held by consumers. Better understanding of such factors can lead to strategies to promote the product among consumers, and in this case, encourage dissemination. The goal of the study was to investigate relationships between interest in hypnosis use and: 1) attitudes about hypnosis; 2) beliefs about the effectiveness of hypnosis (i.e., hypnosis credibility, and hypnosis effectiveness expectancies); 3) past experience with hypnosis; and 4) the perceived hedonic value and utility of hypnosis. The study also explored participants' preferences for hypnosis delivery method (i.e., live or recorded), as well as preferences for hypnosis labeling (i.e., how hypnosis is defined). Participants (N = 509) were recruited through Amazon Mechanical Turk and completed an anonymous online survey. The results revealed that participants' attitudes about hypnosis, their expectancies for the effectiveness of hypnosis, and the perceived hedonic value of hypnosis accounted for unique variance in participants' interest in hypnosis, ps < .05. Together, these variables accounted for 73% of the variance in participants' interest in hypnosis use. Based on these findings, we recommend that these key variables should be considered when planning for greater dissemination and uptake of empirically supported hypnosis interventions.

Cancer Victim Identity for Individuals with Histories of Cancer and Childhood Sexual Abuse.

Identifying as a 'cancer victim' has been linked to adverse psychosocial sequelae in individuals who have been diagnosed with cancer. Being a childhood sexual abuse (CSA) survivor may predispose individuals towards a "victim" identity in general. The aim of this study was to determine the prevalence of identifying as a 'cancer victim' among CSA survivors who were diagnosed with cancer as adults, and to explore psychological factors associated with identification as a cancer victim. 105 adults reporting both a history of CSA and of having been diagnosed with cancer as an adult were recruited through Amazon Mechanical Turk. Variables assessed included CSA severity, abuse-related powerlessness, general mastery, and cancer victim identity. Fifty-one percent of the sample endorsed a cancer victim identity. Path analysis revealed that abuse-related powerlessness was related to decreased feelings of general mastery, which was in turn associated with cancer victim identification (x2 = .12, DF = 1, p < .73; RMSEA = .00; SRMR = .01: Bentler CFI = 1.0). From a clinical perspective, the results suggest that increasing general mastery in CSA survivors in the cancer setting may be an important mechanism for attenuating the risk for developing a cancer victim identity and, presumably, for downstream adverse psychosocial sequelae.

Cognitive-Behavioral Therapy Plus Hypnosis for Distress During Breast Radiotherapy: A Randomized Trial.

Radiotherapy is a common and effective treatment for women with breast cancer. However, radiotherapy has also been shown to adversely affect patients' emotional well-being. Currently, few mind-body interventions are designed to improve patients' quality of life during radiotherapy. One intervention which has demonstrated clinical efficacy in the breast cancer radiotherapy setting is Cognitive-Behavioral Therapy plus Hypnosis. The goal of this study was to investigate the impact of Cognitive-Behavioral Therapy plus Hypnosis on emotional distress in women with breast cancer undergoing radiotherapy. One hundred patients were randomly assigned to either the Cognitive-Behavioral Therapy plus Hypnosis (n = 50) or Attention Control (n = 50) group. Results revealed significant benefits of Cognitive-Behavioral Therapy plus Hypnosis on emotional distress at the mid-point (d = 0.54), the conclusion (d = 0.64), and 4 weeks following the conclusion (d = 0.65) of radiotherapy (all ps < 0.05). In summary, results support further study of Cognitive-Behavioral Therapy plus Hypnosis as an evidence-based intervention to reduce emotional distress in women with breast cancer. Cognitive-Behavioral Therapy plus Hypnosis has the benefits of being brief, noninvasive, lacking side-effects, and producing beneficial effects which last beyond the conclusion of radiotherapy. Given these strengths, we propose that Cognitive-Behavioral Therapy plus Hypnosis is a strong candidate for greater dissemination and implementation in cancer populations.

A Systematic Review and Taxonomy of Published Quality Criteria Related to the Evaluation of User-Facing eHealth Programs.

The purpose of this review was to identify and classify key criteria concepts related to the evaluation of user-facing eHealth programs. In line with the PRISMA statement methodology, computer searches of relevant databases were conducted for studies published between January 1, 2000 and March 1, 2016 that contained explicit quality criteria related to mHealth and eHealth products. Reference lists of included articles, review articles, and grey literature (e.g., books, websites) were searched for additional sources. A team of nine experts led by the first author was gathered to support the classification of these criteria. Identified criteria were extracted, grouped and organized using an inductive thematic analysis. Eighty-four sources - emanating from 26 different courtiers - were included in this review. The team extracted 454 criteria that were grouped into 11 quality domains, 58 criteria concepts and 134 concepts' sub-groups. Quality domains were: Usability, Visual Design, User Engagement, Content, Behavior Change/Persuasive Design, Influence of Social Presence, Therapeutic Alliance, Classification, Credibility/Accountability, and Privacy/Security. Findings suggest that authors around the globe agree on key criteria concepts when evaluating user-facing eHealth products. The high proportion of new published criteria in the second half of this review time-frame (2008-2016), and more specifically, the high proportion of criteria relating to persuasive design, therapeutic alliance and privacy/security within this time-frame, points to the advancements made in recent years within this field.

Building partnerships: a pilot study of stakeholders' attitudes on technology disruption in behavioral health delivery and research.

Collaborations between scientists, care providers, and technology industry professionals are becoming more relevant for developing, testing, and implementing behavioral health technologies. As the need for such partnerships increases, it is important to understand stakeholders' attitudes about their role in partnering for developing such technologies and how much do they expect technology to impact behavioral research and care. The aim of this study was to investigate how much technology disruption do stakeholders expect in healthcare, as well as their perceived contribution in partnering for developing behavioral health technologies. Stakeholders (N = 74) responded to an online convenience sampling survey. Over 89% of participants reported expecting that technology will bring at least a moderate amount of disruption in the current models of behavioral healthcare, with respondents with the most experience in digital health expecting the most disruption. As for their perception of each other's role in partnering for developing behavioral health technologies, one group's weakness was considered to be complemented by another group's strength. Academics were perceived as having more theoretical and research expertise but being less technology-savvy, while industry professionals were considered to excel at technological and marketing activities. Providers were considered to have the most clinical and real-world healthcare industry expertise. Our results indicate that technology is expected to disrupt current healthcare models, while also highlighting the need for collaboration, as no single group was considered to have sufficient expertise and resources to develop successful, effective behavioral health technologies on its own. These results may contribute to a better understanding of how technology disruption is affecting behavioral healthcare from the standpoint of its key players, which may lead to better collaborative models of research and care delivery.

Anxiety: There is an app for that. A systematic review of anxiety apps.

BACKGROUND: Smartphones and mobile devices have become ubiquitous, and with the rapid advance of technology, the number of health applications (apps) that are available for consumers on these devices is constantly growing. In particular, there has been a recent proliferation of anxiety apps. However, there has been no review of the quality or content of these anxiety apps and little is known about their purpose, the features they contain, and their empirical support. The goal of this systematic review was to assess the commercially available anxiety apps. METHODS: A list of anxiety apps was collected in January 2017, using the Power Search function of iTunes and Google Play. Of 5,078 identified apps, 52 met our inclusion criteria (i.e., being defined as an anxiety/worry relief app, and offering psychological techniques aimed primarily at reducing anxiety) and were further reviewed. RESULTS: The majority (67.3%) of the currently available anxiety apps were found to lack the involvement of health care professionals in their development, and very few (3.8%) of them have been rigorously tested. CONCLUSIONS: At the moment, although anxiety apps have the potential to enhance access to mental health care, there is a marked discrepancy between the wealth of commercially available apps, and the paucity of data regarding their efficacy and effectiveness. Although the great promise of apps is their ability to increasing access to evidence-based mental health, the field is not quite there yet and the full potential of apps for treating anxiety has yet to be exploited.

Hypnosis for Symptom Control in Cancer Patients at the End-of-Life: A Systematic Review.

Hypnosis has been shown to alleviate symptoms and side effects of cancer and its treatment. However, less is known about the use of hypnosis at the end of life in individuals with cancer. Our goal was to systematically review the literature on the use of hypnosis to manage the most common symptoms of end-of-life cancer patients: fatigue, sleep disturbances, pain, appetite loss, and dyspnea. EMBASE, MEDLINE, COCHRANE, PsychINFO, and SCOPUS databases were searched from inception through November 7, 2016. No studies met the inclusion criteria. It appears that hypnosis has never been rigorously tested as a means to ameliorate the most common symptoms in individuals with cancer at the end of their lives. This finding is troubling, as it strongly implies that a population most in need has been largely neglected. However, a clear future research direction is revealed that may have significant clinical impact.

Randomized controlled trial of a cognitive-behavioral therapy plus hypnosis intervention to control fatigue in patients undergoing radiotherapy for breast cancer.

PURPOSE: The objective of this study was to test the efficacy of cognitive-behavioral therapy plus hypnosis (CBTH) to control fatigue in patients with breast cancer undergoing radiotherapy. We hypothesized that patients in the CBTH group receiving radiotherapy would have lower levels of fatigue than patients in an attention control group. PATIENTS AND METHODS: Patients (n = 200) were randomly assigned to either the CBTH (n = 100; mean age, 55.59 years) or attention control (n = 100; mean age, 55.97 years) group. Fatigue was measured at four time points (baseline, end of radiotherapy, 4 weeks, and 6 months after radiotherapy). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue subscale and Visual Analog Scales (VASs; Fatigue and Muscle Weakness). RESULTS: The CBTH group had significantly lower levels of fatigue (FACIT) at the end of radiotherapy (z, 6.73; P < .001), 4-week follow-up (z, 6.98; P < .001), and 6-month follow-up (z, 7.99; P < .001) assessments. Fatigue VAS scores were significantly lower in the CBTH group at the end of treatment (z, 5.81; P < .001) and at the 6-month follow-up (z, 4.56; P < .001), but not at the 4-week follow-up (P < .07). Muscle Weakness VAS scores were significantly lower in the CBTH group at the end of treatment (z, 9.30; P < .001) and at the 6-month follow-up (z, 3.10; P < .02), but not at the 4-week follow-up (P < .13). CONCLUSION: The results support CBTH as an evidence-based intervention to control fatigue in patients undergoing radiotherapy for breast cancer. CBTH is noninvasive, has no adverse effects, and its beneficial effects persist long after the last intervention session. CBTH seems to be a candidate for future dissemination and implementation.

The role of specific and core dysfunctional beliefs in breast cancer radiotherapy patients' fatigue.

The goal of the study was to examine the relationships among fatigue catastrophizing, core dysfunctional beliefs, and fatigue in breast cancer radiotherapy patients. Seventy-eight patients participated in the study (mean age = 56.3, standard deviation = 10.5). Patients completed questionnaires on fatigue catastrophizing, core dysfunctional beliefs, and fatigue in their last week of radiotherapy. Using bootstrapping procedures to obtain estimates and confidence intervals for indirect effects, results showed that core beliefs (Need for Comfort and Demandingness for Fairness) had significant indirect effects on fatigue through fatigue catastrophizing, as indicated by the 95 percent confidence interval (.02-.19 for Need for Comfort; .01-.16 for Demandingness for Fairness).

Hypnosis--there's an app for that: a systematic review of hypnosis apps.

This study systematically reviews the hypnosis apps available via iTunes that were compatible with iPhone or iPad. Of 1455 apps identified on iTunes, 407 met inclusion criteria and were further reviewed. Most common hypnosis app targets were weight loss (23%), boosting self-esteem (20%), and relaxation/stress reduction (19%); 83% of apps delivered hypnosis via audio track, and 37% allowed tailoring. Less than 14% of apps reported disclaimers. None of the apps reported having been tested for efficacy, and none reported being evidence based. Although apps have the potential to enhance hypnosis delivery, it seems as though technology has raced ahead of the supporting science. Recommendations from clinical researchers and policy makers are needed to inform responsible hypnosis app development and use.

Clinicians' attitudes toward therapeutic alliance in E-therapy.

Although therapeutic alliance is a crucial factor in face-to-face therapies, no data exist on clinicians' attitudes towards alliance in E-therapy. The study explored clinicians' perceived importance of alliance in E-therapy, clinicians' confidence in their skills to develop alliance in E-therapy, and whether attitudes towards alliance in E-therapy are associated with intended E-therapy practice. Clinicians (n = 106) responded to an online survey. The majority of clinicians considered alliance to be extremely important in both face-to-face therapy and E-therapy. However, clinicians' ratings of the importance of alliance in face-to-face therapies were significantly higher than their ratings of the importance of alliance in E-therapy. Clinicians reported less confidence in their skills to develop alliance in E-therapy than in face-to-face therapy. Intended E-therapy practice correlated with confidence in one's ability to develop alliance in E-therapy and with previous E-therapy practice.

The therapeutic relationship in e-therapy for mental health: a systematic review.

BACKGROUND: E-therapy is defined as a licensed mental health care professional providing mental health services via e-mail, video conferencing, virtual reality technology, chat technology, or any combination of these. The use of e-therapy has been rapidly expanding in the last two decades, with growing evidence suggesting that the provision of mental health services over the Internet is both clinically efficacious and cost effective. Yet there are still unanswered concerns about e-therapy, including whether it is possible to develop a successful therapeutic relationship over the Internet in the absence of nonverbal cues. OBJECTIVE: Our objective in this study was to systematically review the therapeutic relationship in e-therapy. METHODS: We searched PubMed, PsycINFO, and CINAHL through August 2011. Information on study methods and results was abstracted independently by the authors using a standardized form. RESULTS: From the 840 reviewed studies, only 11 (1.3%) investigated the therapeutic relationship. The majority of the reviewed studies were focused on the therapeutic alliance-a central element of the therapeutic relationship. Although the results do not allow firm conclusions, they indicate that e-therapy seems to be at least equivalent to face-to-face therapy in terms of therapeutic alliance, and that there is a relationship between the therapeutic alliance and e-therapy outcome. CONCLUSIONS: Overall, the current literature on the role of therapeutic relationship in e-therapy is scant, and much more research is needed to understand the therapeutic relationship in online environments.

Distress and emotional well-being in breast cancer patients prior to radiotherapy: an expectancy-based model.

Understanding precursors to distress and emotional well-being (EWB) experienced in anticipation of radiotherapy would facilitate the ability to intervene with this emotional upset (i.e. higher distress, lower EWB). Thus, this study tested an expectancy-based model for explaining emotional upset in breast cancer patients prior to radiotherapy. Women affected by breast cancer (N = 106) were recruited and participants completed questionnaires prior to commencing radiotherapy. Structural equation modelling was used to test a cross-sectional model, which assessed the ability of dispositional optimism (Life Orientation Test-Revised - two factors), response expectancies (Visual Analog Scale items), medical (type of surgery, cancer stage and chemotherapy history) and demographic (age, race, ethnicity, education and marital status) variables to predict both EWB (Functional Assessment of Chronic Illness Therapy - Emotional Well-being Subscale) and distress (Profile of Mood States - short version). The model represented a good fit to the data accounting for 65% of the variance in EWB and 69% in distress. Significant predictors of emotional upset were pessimism, response expectancies, Latina ethnicity, cancer stage and having had a mastectomy. These variables explained a large portion of emotional upset experienced prior to radiotherapy for breast cancer and are important to consider when aiming to reduce distress and improve EWB in this context.

Slowing down the clock: a review of experimental studies investigating psychological time dilation.

A review of 24 experiments investigated the factors that produce a subjective time dilation. The aim of this review was to investigate the magnitude of the obtained time dilation. The mean time duration judgment ratio of subjective time to objective time for the selected studies was 1.31, SD = .24. The analyses revealed that experimental studies investigating subjective time dilation tend to obtain small to moderate time dilation and that several factors can be manipulated in order to make a specific time interval appear longer than it is. Highlighting the factors that lead to a subjective time dilation has both research implications, by pointing to the underlying cognitive mechanisms of time perception, and practical implications, by indicating the factors that can be manipulated in order to control how we perceive time.