Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial.

PURPOSE: Patients with cancer often experience elevated levels of distress. This double-blind, randomized controlled trial compared the impact of an app-based version of cognitive behavioral stress management (CBSM) versus a health education sham app on anxiety and depression symptoms. METHODS: Patients with nonmetastatic (stage I-III) cancer who were receiving or recently completed (≤6 months) systemic treatment were recruited nationwide. The primary outcome of change in anxiety symptoms (PROMIS-Anxiety) over 12 weeks and the top secondary outcome of change in depression symptoms (PROMIS-Depression) over 12 weeks were analyzed using mixed-effects modeling with repeated measures (weeks 0, 4, 8, 12). Patient global impressions of change in anxiety and depression were reported at weeks 4, 8, and 12. In addition, self-reported adverse events were collected throughout the study and adjudicated by the site principal investigator. RESULTS: Four hundred forty-nine patients were enrolled in the trial (age M [standard deviation] = 52.44 [11.46]; 81% female; 76% White; 53% breast cancer). Patients randomly assigned to digitized CBSM showed significantly greater reductions in anxiety (B = -0.03; P = .019) and depression (B = -0.02; P = .042) symptoms over 12 weeks. Patients who received digitized CBSM were also significantly more likely to perceive much or very much improvement (v no/minimal change or much/very much worse) in their symptoms of anxiety (χ2 = 31.76; P < .001) and depression (χ2 = 19.70; P < .001) compared with the control. CONCLUSION: The use of digitized CBSM led to significant improvements in anxiety and depression outcomes compared with the sham app.

Changing cancer mindsets: A randomized controlled feasibility and efficacy trial.

OBJECTIVE: A cancer diagnosis and subsequent treatment can disrupt the full spectrum of physical, social, emotional, and functional quality of life. But existing psychological treatments are focused primarily on specific psychological symptoms as opposed to improving the overall patient experience. We studied the feasibility and efficacy of a novel digital intervention targeting patient mindsets-core assumptions about the nature and meaning of illness-designed to improve overall health-related quality of life (HRQoL) in newly diagnosed cancer patients undergoing treatment with curative intent. METHODS: Recently diagnosed (≤150 days) adult patients with non-metastatic cancers undergoing systemic treatment (N = 361) were recruited from across the United States to participate in this decentralized clinical trial. Patients were randomized 1:1 to receive the Cancer Mindset Intervention (CMI) or Treatment as Usual (TAU). Participants in the CMI group completed seven online modules over 10 weeks (2.5 h total) targeting mindsets about cancer and the body. The primary outcome was overall HRQoL, and secondary outcomes were coping behaviors and symptom distress. RESULTS: Patients in the CMI group reported significant (p < 0.001) improvements in adaptive mindsets about cancer and the body over time. Compared with the TAU condition, the CMI group reported significant improvements in overall HRQoL (B = 0.60; 95% CI 0.34-0.85; p < 0.001), increased engagement in adaptive coping behaviors (B = 0.03; 95% CI 0.02-0.04; p < 0.001), and reduced distress from physical symptoms (B = -0.29; 95% CI -0.44 to -0.14; p < 0.01). Effect sizes of these changes ranged from d = 0.42-d = 0.54. CONCLUSION: A brief mindset-focused digital intervention was effective at improving physical, social, emotional, and functional HRQoL, increasing adaptive coping behaviors, and reducing physical symptom distress in newly diagnosed cancer patients.

Anxiety, Depression, and Stress Reaction/Adjustment Disorders and Their Associations with Healthcare Resource Utilization and Costs Among Newly Diagnosed Patients With Breast Cancer.

Background: Breast cancer is the most common cancer among women in the United States. Newly diagnosed patients with breast cancer often experience anxiety, depression, and stress. However, the impact of psychological distress on healthcare resource utilization (HCRU) and costs has not been adequately assessed. Objectives: To evaluate the incidence and prevalence of anxiety, depression, and stress reaction/adjustment disorder among patients newly diagnosed with breast cancer, to examine HCRU and costs, and to assess the association of these psychiatric disorders with costs. Methods: This retrospective observational cohort study was conducted using a large US administrative claims database with an index date of newly diagnosed breast cancer. Demographics and comorbidities (including anxiety, depression, and stress reaction/adjustment disorder) were assessed using data collected 12 months before and after the index date. HCRU and costs were assessed using data collected 12 months after the index date. Generalized linear regressions were performed to examine the association between healthcare costs and anxiety, depression, and stress reaction/adjustment disorder. Results: Of 6392 patients with newly diagnosed breast cancer, 38.2% were diagnosed with psychiatric disorders including anxiety (27.7%), depression (21.9%), or stress reaction/adjustment disorder (6%). The incidence of these psychiatric disorders was 15% and the prevalence was 23.2%. Patients with anxiety, depression, or stress reaction/adjustment disorder had higher rates of several types of HCRU (P < .0001) and higher total all-cause costs compared with patients without these psychiatric disorders (P < .0001). Patients with incident anxiety, depression, or stress reaction/adjustment disorder incurred higher all-cause costs in the first year following breast cancer diagnosis than those with prevalent anxiety, depression, or stress reaction/adjustment disorder (P < .0003), or those without these psychiatric disorders (P < .0001). Discussion: Of patients with anxiety, depression, or stress reaction/adjustment disorder, those with incident psychiatric disorders had higher healthcare costs, suggesting that new-onset psychological distress may contribute to higher costs incurred by the payer. Timely treatment of psychiatric disorders in this population may improve clinical outcomes and reduce HCRU and costs. Conclusions: Anxiety, depression, and stress reaction/adjustment disorder were common among patients newly diagnosed with breast cancer and were associated with increased healthcare costs in the first year following breast cancer diagnosis.

Incremental Health Care Costs of Anxiety and Depression Among Medicare Beneficiaries With Cancer.

PURPOSE: Mental health comorbidities are commonplace among patients with cancer and have been associated with adverse health outcomes and elevated health care costs. Given the rapidly evolving cancer care landscape, an updated understanding of the prevalence and costs of mental health conditions among patients with cancer is needed. This study assessed the incremental costs of anxiety and depression among Medicare beneficiaries with cancer. METHODS: This retrospective cohort study used the SEER-Medicare database. Patients diagnosed with melanoma, breast, lung, prostate, or colorectal cancer between July 2013 and December 2017 were followed for at least 12 months and up to 36 months after cancer diagnosis. Patients were categorized on the basis of anxiety/depression (AD) diagnosis: (1) predating cancer, (2) onset after cancer, or (3) no AD. Multivariable regression was used to estimate differences in all-cause incremental costs (before v after cancer) between the three groups. RESULTS: Of 230,626 patients, 10% had AD before their cancer diagnosis and 22% were diagnosed after cancer. In the first year after cancer diagnosis, average monthly health care costs were $5,750 in US dollars (USD) for patients with newly onset, $5,208 (USD) for patients with preexisting, and $3,919 (USD) for patients without a diagnosis of AD. The incremental cost of cancer was the greatest among patients with newly onset AD-$1,458 (USD) per month greater than those with no AD. Similar patterns were observed across cancer types and stages. CONCLUSION: One in three Medicare beneficiaries with cancer in this study had a diagnosis of anxiety or depression. Newly onset AD is associated with an increase in health care costs of $17,496 (USD) per year. Screening and management of mental health conditions for patients with cancer should be part of coordinated oncology care.

Multimorbidity and Its Associations With Anxiety and Depression Among Newly Diagnosed Patients With Breast Cancer: A Retrospective Observational Cohort Study in a US Commercially Insured and Medicare Advantage Population.

BACKGROUND: Multimorbidity is common in patients with breast cancer, thus increasing the complexity of cancer care and economic burden, worsening their prognosis and quality of life. The prevalence of multimorbidity and its influence on psychological distress among patients with breast cancer have not been well characterized. OBJECTIVES: To examine the prevalence of multimorbidity and its associations with anxiety and depression among newly diagnosed patients with breast cancer. METHODS: We conducted a retrospective observational cohort study using a large administrative claims database. Patients with breast cancer (ICD-10-CM: C50.x) were identified during the study period (1/1/2017-12/31/2020). The index date was defined as the diagnosis date of breast cancer. Demographics and comorbid conditions were assessed using data within 12 months prior to the index date. Multimorbidity was defined as the presence of ≥2 comorbid conditions. Anxiety and depression were examined using data within 12 months after the index date. Multivariable logistic regressions were performed to examine the associations between multimorbidity and anxiety and depression, adjusting for sociodemographic factors. RESULTS: Of the 6392 patients with newly diagnosed breast cancer, 86.9% had multimorbidity at the time of breast cancer diagnosis. The median number of comorbid conditions was 5. Overall, 27.7% experienced anxiety, and 21.9% experienced depression in the first year following breast cancer diagnosis. An increased number of comorbid conditions was associated with elevated prevalence of both anxiety and depression. After adjusting for possible confounding factors, number of comorbid conditions was significantly associated with risk of anxiety (adjusted odds ratio [95% confidence interval (CI)]: 1.17 [1.15-1.19]), and depression (1.24 [1.21-1.26]); all P < .0001. CONCLUSIONS: Multimorbidity was highly prevalent among patients with breast cancer and was strongly associated with increased risk of anxiety and depression in the first year following breast cancer diagnosis. The presence of multimorbidity, anxiety, and depression should be considered in the context of clinical decision making to optimize cancer care and improve mental health and quality of life.

Association of illness mindsets with health-related quality of life in cancer survivors.

OBJECTIVE: This study aimed to examine the association between mindsets-established, but mutable beliefs that a person holds-and health-related quality of life in survivors of breast and gynecologic cancer. METHOD: A cross-sectional survey study was conducted with breast and gynecologic cancer survivors. Measures included the Illness Mindset Questionnaire and Functional Assessment of Cancer Therapy-General (FACT-G). RESULTS: Two hundred seventy-three survivors (74% breast/26% gynecologic) who were on average 3.9 years post-diagnosis (SD = 4.2), Mage 55 (SD = 12) completed the survey (response rate 80%). Of the survivors, 20.1% (N = 55) endorsed ("agree" or "strongly agree") that Cancer is a Catastrophe, 52.4% (N = 143) endorsed that Cancer is Manageable, and 65.9% (N = 180) endorsed that Cancer can be an Opportunity (not mutually exclusive). Those who endorsed a maladaptive mindset (Cancer is a Catastrophe) reported lower health-related quality of life (HRQOL) compared with those who did not hold this belief (p < .001). Alternatively, those who endorsed more adaptive mindsets (Cancer is Manageable or Cancer can be an Opportunity) reported better HRQOL compared with those who disagreed (all p-values < .05). All three mindsets were independent correlates of HRQOL, explaining 6-15% unique variance in HRQOL, even after accounting for demographic and medical factors. CONCLUSIONS: Mindsets about illness are significantly associated with HRQOL in cancer survivors. Our data come from a one-time evaluation of cancer survivors at a single clinic and provide a foundation for future longitudinal studies and RCTs on the relationship between mindsets and psychosocial outcomes in cancer survivors. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Making sense of a pandemic: Mindsets influence emotions, behaviors, health, and wellbeing during the COVID-19 pandemic.

RATIONALE: As the SARS-COV-2 virus spread across the world in the early months of 2020, people sought to make sense of the complex and rapidly evolving situation by adopting mindsets about what the pandemic was and what it meant for their lives. OBJECTIVE: We aimed to measure the mindsets of American adults over the first six months of the COVID-19 pandemic to understand their relative stability over time and their relationship with emotions, behaviors, experiences, and wellbeing. METHODS: American adults (N = 5,365) were recruited in early March of 2020 to participate in a longitudinal survey with follow-up surveys at 6-weeks and 6-months. Three mindsets that people formed about the COVID-19 pandemic were measured: 'the pandemic is a catastrophe', 'the pandemic is manageable' and 'the pandemic can be an opportunity'. RESULTS: In line with our pre-registered hypotheses, these mindsets were associated with a unique and largely self-fulfilling pattern of emotions (positive, negative), behaviors (healthy, unhealthy, and compliance with CDC guidelines), experiences (growth/connection, isolation/meaninglessness) and wellbeing (physical health, mental health, quality of life). Moreover, mindsets formed in the first week of the pandemic were associated with quality of life 6 months later, an effect that was mediated by emotions and health behaviors. CONCLUSION: The mindsets that people adopted about the COVID-19 pandemic - that it is 'a catastrophe', 'manageable', or 'an opportunity' may explain some of the heterogeneity in the lived experiences of Americans through their self-fulfilling impact on peoples' emotions, health behaviors, and wellbeing.

Mindset is associated with future physical activity and management strategies in individuals with knee osteoarthritis.

BACKGROUND: Despite the benefits of physical activity for individuals with knee osteoarthritis (KOA), physical activity levels are low in this population. OBJECTIVES: We conducted a repeated cross-sectional study to compare mindset about physical activity among individuals with and without KOA and to investigate whether mindset relates to physical activity. METHODS: Participants with (n = 150) and without (n = 152) KOA completed an online survey at enrollment (T1). Participants with KOA repeated the survey 3 weeks later (T2; n = 62). The mindset questionnaire, scored from 1 to 4, assessed the extent to which individuals associate the process of exercising with less appeal-focused qualities (e.g., boring, painful, isolating, and depriving) versus appeal-focused (e.g., fun, pleasurable, social, and indulgent). Using linear regression, we examined the relationship between mindset and having KOA, and, in the subgroup of KOA participants, the relationship between mindset at T1 and self-reported physical activity at T2. We also compared mindset between people who use medication for management and those who use exercise. RESULTS: Within the KOA group, a more appeal-focused mindset was associated with higher future physical activity (ß=38.72, p = 0.006) when controlling for demographics, health, and KOA symptoms. Individuals who used exercise with or without pain medication or injections had a more appeal-focused mindset than those who used medication or injections without exercise (p<0.001). A less appeal-focused mindset regarding physical activity was not significantly associated with KOA (ß = -0.14, p = 0.067). Further, the mindset score demonstrated strong internal consistency (α = 0.92; T1; n = 150 and α = 0.92; T2; n = 62) and test-retest reliability (intraclass correlation coefficient (ICC) > 0.84, p < 0.001) within the KOA sample. CONCLUSIONS: In individuals with KOA, mindset is associated with future physical activity levels and relates to the individual's management strategy. Mindset is a reliable and malleable construct and may be a valuable target for increasing physical activity and improving adherence to rehabilitation strategies involving exercise among individuals with KOA.

Using social and behavioural science to support COVID-19 pandemic response.

The COVID-19 pandemic represents a massive global health crisis. Because the crisis requires large-scale behaviour change and places significant psychological burdens on individuals, insights from the social and behavioural sciences can be used to help align human behaviour with the recommendations of epidemiologists and public health experts. Here we discuss evidence from a selection of research topics relevant to pandemics, including work on navigating threats, social and cultural influences on behaviour, science communication, moral decision-making, leadership, and stress and coping. In each section, we note the nature and quality of prior research, including uncertainty and unsettled issues. We identify several insights for effective response to the COVID-19 pandemic and highlight important gaps researchers should move quickly to fill in the coming weeks and months.

What constitutes a 'successful' recovery? Patient perceptions of the recovery process after a traumatic injury.

BACKGROUND: As the number of patients surviving traumatic injuries has grown, understanding the factors that shape the recovery process has become increasingly important. However, the psychosocial factors affecting recovery from trauma have received limited attention. We conducted an exploratory qualitative study to better understand how patients view recovery after traumatic injury. METHODS: This qualitative, descriptive study was conducted at a Level One university trauma center. Participants 1-3 years postinjury were purposefully sampled to include common blunt-force mechanisms of injuries and a range of ages, socioeconomic backgrounds and injury severities. Semi-structured interviews explored participants' perceptions of self and the recovery process after traumatic injury. Interviews were transcribed verbatim; the data were inductively coded and thematically analyzed. RESULTS: We conducted 15 interviews, 13 of which were with male participants (87%); average hospital length of stay was 8.9 days and mean injury severity score was 18.3. An essential aspect of the patient experience centered around the recovery of both the body and the 'self', a composite of one's roles, values, identities and beliefs. The process of regaining a sound sense of self was essential to achieving favorable subjective outcomes. Participants expressed varying levels of engagement in their recovery process, with those on the high end of the engagement spectrum tending to speak more positively about their outcomes. Participants described their own subjective interpretations of their recovery as most important, which was primarily influenced by their engagement in the recovery process and ability to recover their sense of self. DISCUSSION: Patients who are able to maintain or regain a cohesive sense of self after injury and who are highly engaged in the recovery process have more positive assessments of their outcomes. Our findings offer a novel framework for healthcare providers and researchers to use as they approach the issue of recovery after injury with patients. LEVEL OF EVIDENCE: III-descriptive, exploratory study.

Targeting Mindsets, Not Just Tumors.

Mindsets - core assumptions about the nature and workings of things in the world - are a critical but relatively understudied variable that can influence mental and physical health in patients with cancer. Precise, targeted psychological interventions aimed at instilling adaptive mindsets have the potential to transform supportive care in oncology.

Implementation Challenges Using a Novel Method for Collecting Patient-Reported Outcomes After Injury.

BACKGROUND: Monitoring longitudinal patient-reported outcomes after injury is important for comprehensive trauma care. Current methodologies are resource-intensive and struggle to engage patients. MATERIALS AND METHODS: Patients ≥18 y old admitted to the trauma service were prospectively enrolled. The following inclusion criteria were used: emergency operation, ICU length of stay ≥2 midnights, or hospital length of stay ≥4 d. Validated and customized questionnaires were administered using a novel internet-based survey platform. Three-month follow-up surveys were administered. Contextual field notes regarding barriers to enrollment/completion of surveys and challenges faced by participants were recorded. RESULTS: Forty-seven patients were eligible; 26 of 47 (55%) enrolled and 19 of 26 (73%) completed initial surveys. The final sample included 14 (74%) men and 5 (26%) women. Primary barriers to enrollment included technological constraints and declined participation. Contextual field notes revealed three major issues: competing hospital tasks, problems with technology, and poor engagement. The average survey completion time was 43 ± 27 min-21% found this too long. Seventy-four percent reported the system "easy to use" and 95% reported they would "very likely" or "definitely" respond to future surveys. However, 10 of 26 (38%) patients completed 3-mo follow-up. CONCLUSIONS: Despite a well-rated internet-based survey platform, study participation remained challenging. Lack of email access and technological issues decreased enrollment and the busy hospitalization posed barriers to completion. Despite a thoughtful operational design and implementation plan, the trauma population presented a challenging group to engage. Next steps will focus on optimizing engagement, broadening access to survey reminders, and enhancing integration into clinical workflows.

Mindsets Matter: A New Framework for Harnessing the Placebo Effect in Modern Medicine.

The clinical utility of the placebo effect has long hinged on physicians deceptively administering an objective placebo treatment to their patients. However, the power of the placebo does not reside in the sham treatment itself; rather, it comes from the psychosocial forces that surround the patient and the treatment. To this end, we propose a new framework for understanding and leveraging the placebo effect in clinical care. In outlining this framework, we first present the placebo effect as a neurobiological effect that is evoked by psychological processes. Next, we argue that along with implicit learning and expectation formation, mindsets are a key psychological process involved in the placebo effect. Finally, we illustrate the critical role of the social environment and treatment context in shaping these psychological processes. In doing so, we offer a guide for how the placebo effect can be understood, harnessed, and leveraged in the practice of modern medicine.

Efficacy and Safety of Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, and Placebo for Common Psychiatric Disorders Among Children and Adolescents: A Systematic Review and Meta-analysis.

Importance: Depressive disorders (DDs), anxiety disorders (ADs), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD) are common mental disorders in children and adolescents. Objective: To examine the relative efficacy and safety of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and placebo for the treatment of DD, AD, OCD, and PTSD in children and adolescents. Data Sources: PubMed, EMBASE, PsycINFO, Web of Science, and Cochrane Database from inception through August 7, 2016. Study Selection: Published and unpublished randomized clinical trials of SSRIs or SNRIs in youths with DD, AD, OCD, or PTSD were included. Trials using other antidepressants (eg, tricyclic antidepressants, monoamine oxidase inhibitors) were excluded. Data Extraction and Synthesis: Effect sizes, calculated as standardized mean differences (Hedges g) and risk ratios (RRs) for adverse events, were assessed in a random-effects model. Main Outcomes and Measures: Primary outcomes, as defined by authors on preintervention and postintervention data, mean change data, and adverse event data, were extracted independently by multiple observers following PRISMA guidelines. Results: Thirty-six trials were eligible, including 6778 participants (3484 [51.4%] female; mean [SD] age, 12.9 [5.1] years); 17 studies for DD, 10 for AD, 8 for OCD, and 1 for PTSD. Analysis showed that SSRIs and SNRIs were significantly more beneficial compared with placebo, yielding a small effect size (g = 0.32; 95% CI, 0.25-0.40; P < .001). Anxiety disorder (g = 0.56; 95% CI, 0.40-0.72; P < .001) showed significantly larger between-group effect sizes than DD (g = 0.20; 95% CI, 0.13-0.27; P < .001). This difference was driven primarily by the placebo response: patients with DD exhibited significantly larger placebo responses (g = 1.57; 95% CI, 1.36-1.78; P < .001) compared with those with AD (g = 1.03; 95% CI, 0.84-1.21; P < .001). The SSRIs produced a relatively large effect size for ADs (g = 0.71; 95% CI, 0.45-0.97; P < .001). Compared with participants receiving placebo, patients receiving an antidepressant reported significantly more treatment-emergent adverse events (RR, 1.07; 95% CI, 1.01-1.12; P = .01 or RR, 1.49; 95% CI, 1.22-1.82; P < .001, depending on the reporting method), severe adverse events (RR, 1.76; 95% CI, 1.34-2.32; P < .001), and study discontinuation due to adverse events (RR, 1.79; 95% CI, 1.38-2.32; P < .001). Conclusions and Relevance: Compared with placebo, SSRIs and SNRIs are more beneficial than placebo in children and adolescents; however, the benefit is small and disorder specific, yielding a larger drug-placebo difference for AD than for other conditions. Response to placebo is large, especially in DD. Severe adverse events are significantly more common with SSRIs and SNRIs than placebo.

Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial.

In randomized controlled trials, medication side effects may lead to beliefs that one is receiving the active intervention and enhance active treatment responses, thereby increasing drug-placebo differences. We tested these hypotheses with an experimental double-blind randomized controlled trial of a nonsteroidal anti-inflammatory drug with and without the addition of atropine to induce side effects. One hundred healthy volunteers were told they would be randomized to either combined analgesics that might produce dry mouth or inert placebos. In reality, they were randomized double blind, double-dummy to 1 of the 4 conditions: (1) 100 mg diclofenac + 1.2 mg atropine, (2) placebo + 1.2 mg atropine, (3) 100 mg diclofenac + placebo, or (4) placebo + placebo, and tested with heat-induced pain. Groups did not differ significantly in demographics, temperature producing moderate pain, state anxiety, or depression. Analgesia was observed in all groups; there was a significant interaction between diclofenac and atropine, without main effects. Diclofenac alone was not better than double-placebo. The addition of atropine increased pain relief more than 3-fold among participants given diclofenac (d = 0.77), but did not enhance the response to placebo (d = 0.09). A chain of mediation analysis demonstrated that the addition of atropine increased dry mouth symptoms, which increased beliefs that one had received the active medication, which, in turn, increased analgesia. In addition to this indirect effect of atropine on analgesia (via dry mouth and beliefs), analyses suggest that among those who received diclofenac, atropine directly increased analgesia. This possible synergistic effect between diclofenac and atropine might warrant future research.