A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE

Background People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. Objective The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. Methods Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. Results Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. Conclusions We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. Trial Registration ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467

Dramaturgical Accounts of Transgender Individuals: Impression Management in the Presentation of Self to Specialist Gender Services

Demand for gender dysphoria (GD) treatment has increased markedly over the past decade. Access to gender-affirming treatments is challenging for most people. For dysphoric individuals, much is at stake. Little is known about the specific needs, challenges, and coping strategies of this hard-to-reach group. We examined the experiences of treatment-seeking adolescents and adults using in-depth unstructured interviews with 26 people attending specialist gender services and 14 transgender people not referred to services. Patients with gender dysphoria distrust clinical services and describe considerable anxiety in sustaining their impression management strategies to obtain treatment. An authentic presentation is regarded by some participants, especially non-binary individuals, as inauthentic and emotionally difficult to maintain. Impression management strategies have partial success in accessing services. The presentation of “idealized” selves may result in unmet mental health needs of patients, and the receipt of interventions incongruent with their authentic selves.

Food insufficiency and mental health service utilization in the U.S. during the COVID-19 pandemic

Objective: To estimate the association between food insufficiency and mental health service utilization in the U.S. during the COVID-19 pandemic. Design: Cross-sectional study. Multiple logistic regression models were used to estimate the associations between food insufficiency and mental health service utilization. Setting: U.S. Census Household Pulse Survey data collected in October 2020. Participants: Nationally representative sample of 68,611 U.S. adults. Results: After adjusting for sociodemographic factors, experiencing food insufficiency was associated with higher odds of unmet mental health need (adjusted odds ratio [AOR] 2.90; 95% CI 2.46-3.43), receiving mental health counseling or therapy (AOR 1.51; 95% CI 1.24-1.83), and psychotropic medication use (AOR 1.56; 95% CI 1.35-1.80). Anxiety and depression symptoms mediated most of the association between food insufficiency and unmet mental health need but not the associations between food insufficiency and either receiving mental health counseling/therapy or psychotropic medication use. Conclusions: Clinicians should regularly screen patients for food insufficiency, especially in the wake of the COVID-19 pandemic. Expanding access to supplemental food programs may help to mitigate the need for higher mental health service utilization during the COVID-19 pandemic.

College student interest in teletherapy and self-guided mental health supports during the COVID-19 pandemic

Objective: The COVID-19 pandemic has worsened college students’ mental health while simultaneously creating new barriers to traditional in-person care. Teletherapy and online self-guided mental health supports are two potential avenues for addressing unmet mental health needs when face-to-face services are less accessible, but little is known about factors that shape interest in these supports. Participants: 1,224 U.S. undergraduate students (mean age=20.7; 72.5% female; 40.0% White) participated. Methods: Students completed an online questionnaire assessing interest in teletherapy and self-guided supports. Predictors included age, sex, ethnicity, sexual minority status, and anxiety and depression symptomatology. Results: Interest rates were 20% and 25% for at-cost supports and 70% and 72% for free supports. Older age, higher anxiety symptomatology, and identifying as Asian significantly predicted greater interest levels. Conclusions: Results may inform universities’ efforts to optimize students’ engagement with nontraditional, digital mental health supports, including teletherapy and self-guided programs.

Online Problem-Solving Training with and without Peer Support in Veterans with Unmet Mental Health Needs: A Pilot Study of Feasibility, User Acceptability and Patient Engagement (Preprint)

BACKGROUND Electronic health (eHealth) tools have the potential to meet the mental health needs of individuals who have barriers to accessing in-person treatment. However, most users have less than optimal engagement with eHealth tools. Coaching from peer specialists may increase engagement with eHealth. OBJECTIVE This pilot study aimed to 1) test the feasibility and acceptability of a novel, completely automated online system to recruit, screen, enroll, assess, randomize and then deliver an intervention to a national sample of military veterans with unmet mental health needs, 2) investigate whether phone-based peer support increased usage of an online problem-solving training compared to self-directed use and 3) generate hypotheses about potential mechanisms of action for problem-solving and peer support for future full-scale research. METHODS Veterans (n=81) with unmet mental health needs were recruited via social media advertising and enrolled and randomized to self-directed use of an online problem-solving training called Moving Forward (n=28), peer supported Moving Forward (n=27), or a waitlist control (n=26) (ClinicalTrials.gov NCT03555435). Participants completed pre and post study measures (8 weeks later) of problem-solving skills and confidence as well as mental health symptoms. Satisfaction was assessed at post-treatment and objective use of Moving Forward was measured with number of log-ins. RESULTS Automated recruitment, enrollment and initial assessment methods were feasible and resulted in a diverse sample of veterans with unmet mental health needs from 38 states. Automated follow-up methods resulted in 46% retention. Peer support was delivered with high fidelity and was associated with favorable patient satisfaction. Participants randomized to receive peer support had significantly more Moving Forward logins than self-directed Moving Forward participants, and those who received peer support had greater decreases in depression. Problem-solving confidence was associated with greater Moving Forward use and improvements in mental health symptoms among participants both with and without peer support. CONCLUSIONS Enrolling and assessing individuals in eHealth studies without human contact is feasible, but different methods or designs are necessary to achieve acceptable participant engagement and follow-up rates. Peer support shows potential for increasing engagement in online interventions and in reducing symptoms. Future research should investigate when and for whom peer support of eHealth is helpful. Problem-solving confidence should be further investigated as a mechanism of action for online problem-solving training. CLINICALTRIAL ClinicalTrials.gov NCT03555435

A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE (Preprint)

BACKGROUND People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (<i>F</i>_1,313=13.38; <i>P&lt;</i>.001), GAD-7 (<i>F</i>_1,313=5.87; <i>P</i>=.01), RAS (<i>F</i>_1,313=23.42; <i>P&lt;</i>.001), RSES (<i>F</i>_1,313=19.28; <i>P&lt;</i>.001), and SDS (<i>F</i>_1,313=10.73; <i>P</i>=.001). Large effects were observed for the BDI-II (<i>d=</i>0.58), RAS (<i>d=</i>0.61), and RSES (<i>d=</i>0.64); a moderate effect size was observed for the SDS (<i>d=</i>0.44), and a small effect size was observed for the GAD-7 (<i>d=</i>0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. CLINICALTRIAL ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467