Regulating digital therapeutics for mental health: Opportunities, challenges, and the essential role of psychologists.

With so many promising digital therapeutics for anxiety and obsessive-compulsive (OC) spectrum problems, there is an urgent need to consider how evolving regulatory oversight of digital therapeutics is poised to shift how these tools are developed, evaluated, reimbursed, and delivered. In this commentary, we discuss both opportunities and potential pitfalls associated with emerging government regulations of digital therapeutics for mental health, and we consider how applying the traditional 'prescription-based' medical approval paradigm to digital therapeutics for mental health could ultimately undermine and limit the broad accessibility of these software-based innovations that have been explicitly designed to expand the accessibility of care. For example, the vast majority of behavioural and mental health providers do not have 'prescription privileges' (a term originally rooted in pharmacologic practices), and as a result, under current regulations in the U.S. would not be authorized to make FDA-cleared digital therapeutics available to their patients. This is particularly concerning given that most digital therapeutics for mental health are directly rooted in psychological and behavioural science, yet psychologists would not be authorized to incorporate these innovations into their practice. We consider how synchronizing regulatory standards across countries may prove useful, and we conclude by arguing that multidisciplinary teams making regulatory decisions concerning digital therapeutics for mental health must include representation from the discipline and practice of psychology. PRACTITIONER POINTS: Emerging government regulations of digital therapeutics for mental health present both opportunities and potential pitfalls Applying the traditional 'prescription-based' medical approval paradigm to digital therapeutics for mental health could ultimately undermine the broad accessibility of these software-based innovations. Synchronizing regulatory standards across countries may prove useful. Multidisciplinary teams making regulatory decisions concerning digital therapeutics for mental health must include representation from the field of psychology.

IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety.

BACKGROUND: Digital mental health tools have tended to use psychoeducational strategies based on treatment orientations developed and validated outside of digital health. These features do not map well to the brief but frequent ways that people use mobile phones and mobile phone apps today. To address these challenges, we developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style. IntelliCare apps prioritize interactive skills training over education and are designed for frequent but short interactions. OBJECTIVE: The overall objective of this study was to pilot a coach-assisted version of IntelliCare and evaluate its use and efficacy at reducing symptoms of depression and anxiety. METHODS: Participants, recruited through a health care system, Web-based and community advertising, and clinical research registries, were included in this single-arm trial if they had elevated symptoms of depression or anxiety. Participants had access to the 14 IntelliCare apps from Google Play and received 8 weeks of coaching on the use of IntelliCare. Coaching included an initial phone call plus 2 or more texts per week over the 8 weeks, with some participants receiving an additional brief phone call. Primary outcomes included the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) for anxiety. Participants were compensated up to US $90 for completing all assessments; compensation was not for app use or treatment engagement. RESULTS: Of the 99 participants who initiated treatment, 90.1% (90/99) completed 8 weeks. Participants showed substantial reductions in the PHQ-9 and GAD-7 (P<.001). Participants used the apps an average of 195.4 (SD 141) times over the 8 weeks. The average length of use was 1.1 (SD 2.1) minutes, and 95% of participants downloaded 5 or more of the IntelliCare apps. CONCLUSIONS: This study supports the IntelliCare framework of providing a suite of skills-focused apps that can be used frequently and briefly to reduce symptoms of depression and anxiety. The IntelliCare system is elemental, allowing individual apps to be used or not used based on their effectiveness and utility, and it is eclectic, viewing treatment strategies as elements that can be applied as needed rather than adhering to a singular, overarching, theoretical model. TRIAL REGISTRATION: Clinicaltrials.gov NCT02176226; http://clinicaltrials.gov/ct2/show/NCT02176226 (Archived by WebCite at http://www.webcitation/6mQZuBGk1).

New Electronic Tools for Veterans.

The US Department of Veterans Affairs, in partnership with the Department of Defense, has developed a host of new electronic tools designed to address the mental and behavioral health needs of military service members and veterans. These tools include online self-help programs and companion mobile apps, as well as many of the apps available through the VA App Store. This commentary provides a brief overview of these new tools and discusses some of the ways in which physicians and other medical providers in North Carolina can incorporate these tools into their work with veterans.

Health-related internet use in older primary care patients.

BACKGROUND: Adults aged 65 years and older stand to benefit from the accumulating wealth of Internet-based health resources, including online interventions to assist in the self-management of chronic health conditions. However, concerns have been expressed that lesser Internet use and familiarity among older adults may limit the utility of web-based health interventions in older age groups. As these interventions become more prevalent, it is important to understand older adults' receptivity to using the Internet as a tool in managing healthcare. OBJECTIVE: The purpose of the present study was to gauge the extent to which older primary care patients are receptive to using web-based health resources, and to explore how health-related Internet use may be related to patient characteristics such as age, income, and health and mental health status. METHODS: We surveyed 50 adults aged 65 years and older in a Veterans Administration primary care clinic regarding: (1) Internet use for any purpose, (2) Internet use to obtain health or mental-related information, and (3) interest in using Internet-based interventions to address various health-related needs. A substantial proportion of respondents were in their 70s, 80s, and 90s, and many had multiple medical conditions. RESULTS: Nearly three-quarters of older primary care patients in our sample were regular Internet users and over half had experience in using the Internet to search for health information. The majority of Internet users endorsed an interest in using web-based resources to manage various aspects of their health and mental healthcare. CONCLUSIONS: Our results support the conclusion that older primary care patients, including those among the oldest-old and those with multiple medical conditions, are amenable to using the Internet as a means of enhancing healthcare.

Correlates of hazardous drinking among Veterans with and without hepatitis C.

Hazardous drinking is a major barrier to antiviral treatment eligibility among hepatitis C (HCV) patients. We evaluated differences in substance-related coping, drinking-related consequences, and importance and confidence in ability to change alcohol use among hazardous drinkers with and without HCV (N = 554; 93.5% male). We examined group differences between HCV+ patients (n = 43) and their negative HCV counterparts (n = 511). Results indicate a higher percentage of HCV+ patients report using substances to cope with possible symptoms of PTSD (P < .05) and depression (P < .01), and endorse more lifetime drinking-related negative consequences than HCV patients (P < .01). Furthermore, HCV+ patients place greater importance on changing alcohol use (P < .01) but report less confidence in their ability to change (P < .01). Use of brief assessment and feedback with skills-based interventions to decrease alcohol use may be well-received by HCV+ patients.

Is computerized cognitive-behavioural therapy a treatment option for depression in late-life? A systematic review.

OBJECTIVE: Computerized cognitive-behavioural therapy (CCBT) may enhance older adults' access to evidence-based depression treatment. Our objective was to determine the extent to which adults aged 65 years and older are represented in existing studies of CCBT for depression and describe available data on recruitment, retention, and outcomes. METHODS: We retrieved all controlled and uncontrolled trials of CCBT for depression published between 2000 and 2010. We obtained data on older adults via the article text or correspondence with authors. RESULTS: Older adults comprised approximately 3% of study participants in reviewed studies. Authors reported that older participants may be less likely than younger adults to drop out, but more likely to experience technical challenges. CONCLUSIONS: Older adults are under-represented in studies of CCBT for depression.

Training research: practical recommendations for maximum impact.

This review offers practical recommendations regarding research on training in evidence-based practices for mental health and substance abuse treatment. When designing training research, we recommend: (a) aligning with the larger dissemination and implementation literature to consider contextual variables and clearly defining terminology, (b) critically examining the implicit assumptions underlying the stage model of psychotherapy development, (c) incorporating research methods from other disciplines that embrace the principles of formative evaluation and iterative review, and (d) thinking about how technology can be used to take training to scale throughout all stages of a training research project. An example demonstrates the implementation of these recommendations.

A randomized controlled trial of a therapeutic relational agent for reducing substance misuse during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic disrupted access to treatment for substance use disorders (SUDs), while alcohol and cannabis retail sales increased. During the pandemic, we tested a tailored digital health solution, Woebot-SUDs (W-SUDs), for reducing substance misuse. METHODS: In a randomized controlled trial, we compared W-SUDs for 8 weeks to a waitlist control. U.S. adults (N = 180) who screened positive for substance misuse (CAGE-AID>1) were enrolled June-August 2020. The primary outcome was the change in past-month substance use occasions from baseline to end-of-treatment (EOT). Study retention was 84%. General linear models tested group differences in baseline-to-EOT change scores, adjusting for baseline differences and attrition. RESULTS: At baseline, the sample (age M = 40, SD = 12, 65% female, 68% non-Hispanic white) averaged 30.2 (SD = 18.6) substance occasions in the past month. Most (77%) reported alcohol problems, 28% cannabis, and 45% multiple substances; 46% reported moderate-to-severe depressive symptoms. Treatment participants averaged 920 in-app text messages (SD = 892, Median = 701); 96% of completed lessons were rated positively; and 88% would recommend W-SUDs. Relative to waitlist, W-SUDs participants significantly reduced past-month substance use occasions (M = -9.1, SE = 2.0 vs. M = -3.3, SE = 1.8; p = .039). Secondary substance use and mood outcomes did not change significantly by group; however, reductions in substance use occasions correlated significantly with increased confidence and fewer substance use problems, cravings, depression and anxiety symptoms, and pandemic-related mental health effects (p-value<.05). CONCLUSIONS: W-SUDs was associated with significant reductions in substance use occasions. Reduction in substance use occasions was associated with better outcomes, including improved mental health. W-SUDs satisfaction was high.

Embracing a health services research perspective on personal health records: lessons learned from the VA My HealtheVet system.

BACKGROUND: Personal health records (PHRs) are designed to help people manage information about their health. Over the past decade, there has been a proliferation of PHRs, but research regarding their effects on clinical, behavioral, and financial outcomes remains limited. The potential for PHRs to facilitate patient-centered care and health system transformation underscores the importance of embracing a broader perspective on PHR research. OBJECTIVE: Drawing from the experiences of VA staff to evaluate the My HealtheVet (MHV) PHR, this article advocates for a health services research perspective on the study of PHR systems. METHODS: We describe an organizing framework and research agenda, and offer insights that have emerged from our ongoing efforts regarding the design of PHR-related studies, the need to address PHR data ownership and consent, and the promotion of effective PHR research collaborations. CONCLUSION: These lessons are applicable to other PHR systems and the conduct of PHR research across different organizational contexts.

Exploring potential implementation barriers and facilitators of the SMART Program, a stepped-care package of eHealth HIV prevention interventions for adolescent men who have sex with men.

Little is known about how to best implement eHealth HIV interventions for adolescent men who have sex with men (AMSM) in real-world settings. In response, our current study describes formative implementation research with community-based organizations (CBOs) in preparation for future implementation of the SMART Program, a stepped-care package of three interventions adapted for AMSM. In-depth interviews focusing on eHealth implementation were conducted with a convenience sample of 12 stakeholders from nine CBOs that actively implemented sexual-minority-focused HIV/AIDS prevention programs. Qualitative analysis was conducted using Dedoose to identify salient themes. Most programs implemented at the CBOs engaged adult MSM for HIV prevention, but CBOs reported less experience with outreach of AMSM for HIV prevention. While comfortable with and skilled at implementing traditional in-person HIV prevention programs, interviewees reported that eHealth programs fell outside of their organizations' technical capacities. They suggested specific strategies to facilitate successful implementation of SMART and other eHealth programs, including technical-capacity-building at CBOs, better training of staff, and partnering with a national coordinating center that provides support for the technology. Overall, the CBOs reported enthusiasm for the SMART Program and thought it an efficient way to bridge their current gaps in online programming and lack of AMSM HIV prevention strategies.

A Pilot Trial of Online Training for Family Well-Being and Veteran Treatment Initiation for PTSD.

INTRODUCTION: Family members are important supports for veterans with Posttrauamtic Stress Disroder (PTSD), but they often struggle with their own distress and challenges. The Veterans Affairs-Community Reinforcement and Family Training (VA-CRAFT) website was designed to teach family members of veterans with PTSD effective ways to interact with their veterans to encourage initiation of mental health services as well as to care for themselves and improve their relationships. This article presents a pilot investigation of VA-CRAFT. MATERIALS AND METHOD: Spouse/partners of veterans who had screened positive for PTSD but were not in mental health treatment were randomized to either use the VA-CRAFT website (n = 22) or to a waitlist control condition (n = 19) for 3 months. Veteran mental health service initiation was assessed posttreatment. Spouse/partner distress, caregiver burden, quality of life, and relationship quality were assessed pre and posttreatment. The study was approved by the Minneapolis VA Health Care System Institutional Review Board (IRB). RESULTS: Differences between groups on veteran treatment initiation were small (Phi = 0.17) and not statistically significant. VA-CRAFT participants reported large and statistically significantly greater decreases in overall caregiver burden (η2 = 0.10) and objective caregiver burden (η2 = 0.14) than control participants. Effects were larger for those with greater initial distress. Effects sizes for other partner outcomes were negligible (η2 = 0.01) to medium (η2 = 0.09) and not statistically significant. Postintervention interviews suggested that only 33% of the VA-CRAFT participants talked with their veterans about starting treatment for PTSD during the trial. CONCLUSION: Results from this pilot trial suggest that VA-CRAFT holds initial promise in reducing caregiver burden and as such it could be a useful resource for family members of veterans with PTSD. However, VA-CRAFT does not enhance veteran treatment initiation. It may benefit from enhancements to increase effectiveness and caregiver engagement.

Evaluation of a recommender app for apps for the treatment of depression and anxiety: an analysis of longitudinal user engagement.

Objective: While depression and anxiety are common mental health issues, only a small segment of the population has access to standard one-on-one treatment. The use of smartphone apps can fill this gap. An app recommender system may help improve user engagement of these apps and eventually symptoms. Methods: IntelliCare was a suite of apps for depression and anxiety, with a Hub app that provided app recommendations aiming to increase user engagement. This study captured the records of 8057 users of 12 apps. We measured overall engagement and app-specific usage longitudinally by the number of weekly app sessions ("loyalty") and the number of days with app usage ("regularity") over 16 weeks. Hub and non-Hub users were compared using zero-inflated Poisson regression for loyalty, linear regression for regularity, and Cox regression for engagement duration. Adjusted analyses were performed in 4561 users for whom we had baseline characteristics. Impact of Hub recommendations was assessed using the same approach. Results: When compared to non-Hub users in adjusted analyses, Hub users had a lower risk of discontinuing IntelliCare (hazard ratio = 0.67, 95% CI, 0.62-0.71), higher loyalty (2- to 5-fold), and higher regularity (0.1-0.4 day/week greater). Among Hub users, Hub recommendations increased app-specific loyalty and regularity in all 12 apps. Discussion/Conclusion: Centralized app recommendations increase overall user engagement of the apps, as well as app-specific usage. Further studies relating app usage to symptoms can validate that such a recommender improves clinical benefits and does so at scale.

How are substance use disorders addressed in VA psychiatric and primary care settings? Results of a national survey.

OBJECTIVE: This study examined interventions for substance use disorders within the Department of Veterans Affairs (VA) psychiatric and primary care settings. METHODS: National random samples of 83 VA psychiatry program directors and 102 primary care practitioners were surveyed by telephone. The survey assessed screening practices to detect substance use disorders, protocols for treating patients with substance use disorders, and available treatments for substance use disorders. RESULTS: Respondents reported extensive contact with patients with substance use problems. However, a majority reported being ill equipped to treat substance use disorders themselves; they usually referred such patients to specialty substance use disorder treatment programs. CONCLUSIONS: Offering fewer specialty substance use disorder services within the VA may be problematic: providers can refer patients to specialty programs only if such programs exist. Caring for veterans with substance use disorders may require increasing the capacity of and establishing new specialty programs or expanding the ability of psychiatric programs and primary care practitioners to provide such care.

Prevalence and predictors of research participant eligibility criteria in alcohol treatment outcome studies, 1970-98.

AIMS: To describe the eligibility criteria (i.e. study participant inclusion and exclusion rules) employed in alcohol treatment outcome research and to identify predictors of their use. DESIGN: The eligibility criteria of 683 alcohol treatment outcome studies conducted between 1970 and 1998 were coded reliably into 14 general categories. Predictors of the use of eligibility criteria were then examined. FINDINGS: Patients were most often ruled ineligible for research studies because of their level of alcohol problems (39.1% of studies), comorbid psychiatric problems (37.8%), past or concurrent utilization of alcohol treatment (31.8%), co-occurring medical conditions (31.6%), and because they were deemed non-compliant and unmotivated (31.5%). The number of eligibility criteria employed in studies increased from the 1970s through the 1990s, and was positively associated with funding from the US National Institute of Alcohol Abuse and Alcoholism (NIAAA) and from the private sector, lack of an inpatient/residential treatment condition, presence of a pharmacotherapy, and use of a randomized, multiple-condition design. Principal investigators with doctoral degrees used more eligibility criteria than those with lower degrees. CONCLUSION: Participant eligibility criteria are extensively employed in alcohol treatment outcome research, and vary significantly across historical periods, funders and research designs. Researchers should report the details of subject eligibility criteria and excluded patients more fully, and, evaluate how eligibility criteria affect the cost, feasibility, and generalizability of treatment outcome research.

Satisfaction with substance use treatment and 12-step groups predicts outcomes.

INTRODUCTION: Satisfaction is a critical component of patient-centered care, yet little is known about the degree to which patient satisfaction is linked to subsequent outcomes, especially in substance use disorder (SUD) treatments and 12-step groups. The current study assessed the degree to which satisfaction with Department of Veterans Affairs (VA) outpatient SUD treatment and with 12-step groups, both measured at 6 months after treatment initiation, was associated with additional treatment utilization and better substance-related outcomes during the next 6 months, that is, up to 1 year after treatment initiation. METHODS: Participants were 345 patients entering the VA SUD treatment program. RESULTS: More satisfaction with treatment and with 12-step groups at 6 months was associated with less alcohol use severity and more abstinence at 1 year. More treatment satisfaction was related to less subsequent medical severity, whereas more 12-step group satisfaction was related to less subsequent psychiatric severity. More 12-step group satisfaction was related to subsequent increases in 12-step group attendance and involvement. A single item assessing overall satisfaction appeared best related to subsequent outcomes. CONCLUSIONS: Satisfied SUD treatment patients and 12-step mutual help members appeared to have better subsequent service utilization patterns and treatment outcomes. SUD treatments can improve outcomes by monitoring and enhancing patient satisfaction.

Brief alcohol counseling improves mental health functioning in veterans with alcohol misuse: results from a randomized trial.

BACKGROUND: Alcohol misuse occurs at high rates among U.S. Military Veterans presenting to primary care and is linked to numerous negative social and health consequences. The Veterans Health Administration has recently implemented brief alcohol interventions (BAI) in VA primary care settings. An emerging literature suggests that BAIs that target alcohol consumption may also have secondary health benefits such as reducing symptoms of depression and anxiety in civilian samples. The present study sought to examine whether secondary health benefits of BAIs observed in civilians generalize to a sample of alcohol misusing Veterans presenting to primary care. METHODS: Veterans (N=167) screening positive for alcohol misuse during a routine primary care visit were randomized to receive treatment-as-usual (TAU) or TAU plus a web-delivered BAI. Assessment of overall mental health functioning, posttraumatic stress disorder, and depression occurred at baseline, three- and six-month post-treatment. RESULTS: Veterans receiving both BAI protocols demonstrated significant improvements in mental health functioning, depressive symptoms, and use of approach coping from baseline to six-month follow-up. No differential treatment effects on these outcomes were observed. LIMITATIONS: Findings are limited by the lack of a no-treatment control group, and the potential impact of regression to the mean and assessment effects on outcomes. CONCLUSIONS: Our findings replicate prior studies suggesting that a single-dose BAI may have some secondary mental health benefits for Veterans presenting to primary care with alcohol misuse.

A randomized controlled trial of a web-delivered brief alcohol intervention in Veterans Affairs primary care.

OBJECTIVE: This study sought to examine whether a web-delivered brief alcohol intervention (BAI) is effective for reducing alcohol misuse in U.S. military veterans presenting to primary care. METHOD: Veterans (N = 167) screening positive for alcohol misuse during a routine primary care visit were randomized to receive a BAI plus treatment as usual (TAU) or TAU alone. An assessment of alcohol-related outcomes was conducted at baseline and 3 and 6 months after treatment. RESULTS: Veterans in both study conditions showed a significant reduction in alcohol quantity and frequency and alcohol-related problems at 6-month follow-up. No differential treatment effects on outcomes were observed between the two treatment groups. CONCLUSIONS: This study is the first to explore whether a web-delivered BAI using normative feedback is effective for veterans with alcohol misuse. Our findings suggest that BAIs using normative feedback may not have any additional benefit beyond TAU for older veterans with high rates of comorbid mental health concerns.

A randomized controlled trial of telephone motivational interviewing to enhance mental health treatment engagement in Iraq and Afghanistan veterans.

OBJECTIVE: To test the efficacy of telephone-administered motivational interviewing (MI) to enhance treatment engagement in Iraq and Afghanistan veterans with mental health (MH) problems. METHOD: Between April 23, 2008, and February 25, 2011, 73 Iraq and Afghanistan veterans who screened positive for ≥1 MH problem(s) on telephone-administered psychometric assessment, but were not engaged in treatment, were randomized to either personalized referral for MH services and four sessions of telephone MI or standard referral and four neutral telephone check-in sessions (control) at baseline, 2, 4 and 8 weeks. Blinded assessment occurred at 8 and 16 weeks. RESULTS: In intent-to-treat analyses, 62% assigned to telephone MI engaged in MH treatment compared to 26% of controls [relative risk (RR)=2.41, 95% confidence interval (CI)=1.33-4.37, P=.004], which represented a large effect size (Cohen's h=0.74). Participants in the MI group also demonstrated significantly greater retention in MH treatment than controls [MI mean visits (S.D.)=1.68 (2.73) and control mean visits (S.D.)=0.38 (0.81), incidence rate ratio (IRR)=4.36, 95% CI=1.96-9.68, P<.001], as well as significant reductions in stigma and marijuana use at 8 weeks (P<.05). CONCLUSIONS: Telephone MI enhances MH treatment engagement in Iraq and Afghanistan veterans with MH problems.

Current trends in using Internet and mobile technology to support the treatment of substance use disorders.

ISSUES: By allowing for the efficient delivery of instructional content and the secure collection of self-report data regarding substance use and related problems, the Internet has tremendous potential to improve the effectiveness and accessibility of Substance Use Disorder (SUD) treatment and recovery-oriented services. APPROACH: This article discusses some of the ways in which Internet and mobile technology can facilitate, complement and support the process of traditional clinician-delivered treatment for individuals with SUDs. KEY FINDINGS: Internet applications are being used to support a range of activities including (a) the assessment and feedback process that constitutes a key feature of brief motivational interventions; and (b) the concurrent monitoring of patients who are receiving treatment for SUDs, to support continuing care, and the ongoing recovery of SUD patients who have completed face-to-face treatment. Internet technology is also being used to (c) support efficient delivery of clinical training in evidence-based practices for treating individuals who may have SUDs. IMPLICATIONS: This emerging body of literature suggests that SUD treatment providers and program administrators can enhance the quality of clinician-delivered treatment by incorporating internet applications into existing processes of care and recovery oriented services. CONCLUSION: Internet applications provide an unparalleled opportunity to engage patients in the treatment process, incorporate real-time data into treatment planning, prevent relapse, and promote evidence-based treatment approaches.