A Coached Digital Cognitive Behavioral Intervention Reduces Anxiety and Depression in Adults With Functional Gastrointestinal Disorders.
Traditional cognitive behavioral interventions (CBIs) improve mood and gastrointestinal symptom severity in patients with functional gastrointestinal disorders (FGIDs) but face substantial barriers to implementation. Integrating behavioral health technology into medical clinic workflows could overcome these barriers. We evaluated the feasibility and impact of a coached digital CBI (dCBI) as a first-line intervention in a prospective cohort of emotionally distressed patients with FGID.
Patients with anxiety and/or depressive symptoms were offered a dCBI (an app called RxWell) during routine clinic visits. RxWell provides cognitive behavioral techniques enhanced by within-app text messaging with a health coach. Both gastroenterology and behavioral health-care providers electronically prescribed RxWell. We tracked patient interactions with RxWell, and patients completed anxiety (General Anxiety Disorder-7) and depression (Personal Health Questionniare Depression Scale) measures through the app. Our primary study outcome was the change in General Anxiety Disorder-7 and Personal Health Questionniare Depression Scale scores.
Of 364 patients with FGID (mean age 43 years [SD 16 years]; 73.1% women) prescribed the dCBI, 48.4% enrolled (median use, 3 techniques [interquartile range 1-14]). About half of RxWell enrollees communicated with health coaches. The mean baseline anxiety score was 11.4 (SD 5.5), and the depression score was 11.5 (SD 6.1). RxWell users experienced improvements in anxiety (mean change 2.71 [t = 3.7, df = 58; P < 0.001]) and depression (mean change 2.9 [t = 4.2, df = 45; P < 0.001]) at 4 months.
Patients with FGIDs and moderately severe anxiety and depressive symptoms are willing to use dCBI tools recommended by their providers. Our pilot data demonstrate that dCBI usage is associated with clinically and statistically significant mood symptom reductions.
Szigethy E
，Tansel A
，Pavlick AN
，Marroquin MA
，Serio CD
，Silfee V
，Wallace ML
，Kingsley MJ
，Levinthal DJ
... -
《Clinical and Translational Gastroenterology》
SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery.
Mood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial.
This is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not. The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH.
Our trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.
Kaynar AM
，Lin C
，Sanchez AG
，Lavage DR
，Monroe A
，Zharichenko N
，Strassburger M
，Saucier K
，Groff YJ
，Klatt BA
，O'Malley MJ
，Szigethy E
，Wasan AD
，Chelly JE
... -
《Trials》
Health Care Provider Perspectives on the Use of a Digital Behavioral Health App to Support Patients: Qualitative Study.
Despite the growing evidence indicating the efficacy of digital cognitive behavioral interventions (dCBIs) for behavioral health (BH) treatment, broad and consistent use of such interventions has been limited by knowledge obtained in real-world settings, including factors that impact provider uptake/referral. Engaging providers early in the implementation process offers an opportunity to explore their needs and behaviors, integrate interventions into workflows, and better understand provider setting capabilities.
This study assessed providers' views on the feasibility and acceptability of delivering a cognitive behavioral therapy (CBT)-based mobile app in multiple care settings.
Participating providers included BH and physical health (PH) providers from a women's health center, an outpatient BH clinic, and both rural/urban primary care settings. All participating providers cocreated workflows through facilitated workshops, including establishing feedback loops between the project team and providers and identifying clinical champions at each site. Over a 12-week period, the providers referred adult patients experiencing anxiety or depression to a mobile app-based dCBI, RxWell, and provided other indicated treatments as part of usual care. Referrals were completed by the providers through the electronic medical record. To better understand facilitators of and challenges in integrating RxWell into routine practice and perceptions of sustainability, a series of qualitative interviews was conducted. Interview data were analyzed to identify major themes using an inductive content analysis approach.
A total of 19 provider interviews were conducted to discover motivators and barriers for referring RxWell. The providers benefited from a focused discussion on how to incorporate the referral process into their workflow, and knowing the app content was rooted in evidence. Although the providers believed engaging in experiential learning was important, they indicated that more education on the digital health coach role and how to monitor patient progress is needed. The providers thought patient engagement may be impacted by motivation, a lack of comfort using a smartphone, or preference for in-person therapy. The providers also expressed enthusiasm in continuing to refer the app. They liked the ability to provide patients with support between sessions, to have an extra treatment option that teaches BH exercises, and to have a CBT treatment option that overcomes barriers (eg, wait times, copays, travel) to traditional therapy modalities.
Digital intervention success in health care settings relies heavily on engagement of key stakeholders, such as providers, in both design and implementation of the intervention and focused evaluation within intended care setting(s). Scaling digital interventions to meet the mental health needs of patients in usual care settings leans on thoughtfully constructed and streamlined workflows to enable seamless referral of patients by providers. Our findings strongly suggest that providers are supportive of digital tool integration to support the mental health of patients and endorse its use within their routine workflow.
Silfee V
，Williams K
，Leber B
，Kogan J
，Nikolajski C
，Szigethy E
，Serio C
... -
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