An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study

“All measures were completed on the REDCap (Research Electronic Data Capture; Vanderbilt University) platform, a web-based data collection platform [32,33].”

“All measures were completed on the REDCap (Research Electronic Data Capture; Vanderbilt University) platform, a web-based data collection platform [32,33].”

“During the COVID-19 pandemic, additional challenges to accessing in-person treatment included physical distancing and self-isolation measures related to COVID-19, in addition to the sharp increase in stress, anxiety, and depression associated with the pandemic [6,7].”

“The in-person delivery of cognitive behavioral therapy (CBT) is an effective, evidence-based approach for treating a wide range of mental health conditions with a substantial amount of research indicating its efficacy for the treatment of anxiety [1] and depression [2].”

“The SUS is the most widely used measure that is validated for testing usability across various iCBT programs [26,27], and it is designed to be tailored to the program being tested.”

“Previous research has found that internet-based CBT (iCBT) interventions provide increased access to evidence-based treatment, which can improve the mental health of the general population by effectively reducing symptoms associated with anxiety and depression [8,9].”

“Co-design has many benefits (eg, improved program tailoring) [16], yet this approach appears underused in the literature.”

“Furthermore, engaging mental health–informed peers (eg, people with lived experience of mental health challenges or peer counselors) in program development and evaluation could further illuminate usability characteristics (ie, aspects that contribute to the technical effectiveness and efficiency of a program) [20,21]…”

“treatment is hindered by lengthy wait lists, therapists’ caseload limitations, and the moderate to low availability of clinicians trained in the delivery of evidence-based CBT [4].”

“Furthermore, a recent study examining mobile apps to treat depression [13] found that few programs followed a CBT approach, even though the literature supports CBT as the gold standard for the treatment of anxiety and depression [14].”

“In sum, there appears to be a gap in the literature pertaining to evidence-based iCBT programs that also follow the iCBT recommendations for development, especially for programs targeting co-occurring depression and anxiety [17].”

“Treatment fidelity is defined as “the extent to which an intervention is delivered as intended by the protocol” [10,11].”

“Furthermore, engaging mental health–informed peers (eg, people with lived experience of mental health challenges or peer counselors) in program development and evaluation could further illuminate usability characteristics (ie, aspects that contribute to the technical effectiveness and efficiency of a program) [20,21]…”

“The integration of therapeutic strategies for depression within an iCBT program for anxiety is likely to be beneficial, given the overlap between the symptoms and the core therapeutic strategies used to treat each disorder [38].”

“It was an expected finding that experts would strongly suggest using interventions such as behavioral activation, given its robust efficacy in depression treatment, including within an iCBT format [37].”

“Similarly, usability testing is critical, and Kushniruk [43] found that usability testing with small groups (ie, 8-10 users) can drastically reduce the number of usability issues experienced by users in the future.”

“During the COVID-19 pandemic, additional challenges to accessing in-person treatment included physical distancing and self-isolation measures related to COVID-19, in addition to the sharp increase in stress, anxiety, and depression associated with the pandemic [6,7].”

“Stawarz et al [36] also conducted a qualitative analysis of app reviews, which highlighted the value of leveraging engagement strategies (eg, personalization) to increase user satisfaction with mental health programs [44].”

“Previous research has found that internet-based CBT (iCBT) interventions provide increased access to evidence-based treatment, which can improve the mental health of the general population by effectively reducing symptoms associated with anxiety and depression [8,9].”

“A recent literature review [39] suggested that guided (eg, coaches or therapist support) programs had similar rates of adherence as in-person CBT treatment, which is higher than self-guided programs—guidance appears to positively impact treatment program use [39,40].”

“The accessibility of treatment is further hindered by the monetary costs of treatment outside the public system and geographic access for those living in rural areas [5].”

“Current guidelines for digital mental health interventions strongly suggest using a co-design process [41,42], and the”

“[15]—one of their core recommendations was the use of a co-design process (ie, involvement of intended users in the development of the iCBT intervention).”

“A recent literature review [39] suggested that guided (eg, coaches or therapist support) programs had similar rates of adherence as in-person CBT treatment, which is higher than self-guided programs—guidance appears to positively impact treatment program use [39,40].”

“CBT: cognitive behavioral therapy ECOUTER: Employing Conceptual Schema for Policy and Translation Engagement in Research iCBT: internet cognitive behavioral therapy REDCap: Research Electronic Data Capture SUS: System Usability Scale 2SLGBTQ+: two-spirit, lesbian, gay, bisexual, transgender, queer, and all other membe…”

“Bowie-DaBreo et al [12] described how there is significant uncertainty about the effectiveness of many mental health apps and programs, and much of that uncertainty appears to stem from a lack of information about treatment fidelity.”

“Similarly, a qualitative study of engagement with an iCBT program found that participants wanted to choose what information to learn, accessible content (eg, audiovisual content and appropriate reading level), and a more tailored coaching experience [16,45].”

“Treatment fidelity is defined as “the extent to which an intervention is delivered as intended by the protocol” [10,11].”

“However, inconsistencies regarding treatment fidelity have been identified as a main contributor to the mixed evidence on the effectiveness of many DMHIs [128].”

“Co-design may help improve engagement and a plain language approach to psychological interventions [57], which may potentially be missed in an intervention without a co-design component.”

“Implementation fidelity in GdCBT refers to the degree to which the coaches delivered their guidance according to the trial design and theory of the digital treatment (Patterson, Rossi, Pencer, & Wozney, 2022; Waltz, Addis, Koerner, & Jacobson, 1993).”

“…research exists that supports both codesign and PD as being helpful in enhancing engagement in iCBT programs, particularly for adults (McCall et al. 2021; Patterson et al. 2022), but it is important to implement these strategies across different age cohorts (Lattie et al. 2022; Muller et al. 2024).”

“Some research conducted with adult populations indicates that using user-centered practices may help increase engagement [46,47], but more research is generally needed.”

“…et al., 2020; Flobak et al., 2021), satisfaction (Callan et al., 2021; Hughes-Barton et al., 2023; Wiberg et al., 2022; Lehavot et al., 2021; Patterson et al., 2022; Hidalgo-Mazzei et al., 2016; MacKinnon et al., 2022; Milgrom et al., 2016), perceived feasibility (Callan et al., 2021; Bucci…”

“As treatment fidelity inconsistencies have been identified as a key contributor to the mixed evidence on the effectiveness of many of the DMHIs [22], there is a need to conceptualize and evaluate fidelity in the context of adapting DMHIs from in-person formats.”

“Across these studies, the number and composition of involved stakeholders have varied, from only including service users (children and/or parents) [21–23] to also involving service providers [19, 20, 24] or CBT experts [18].”

“Prior work has shown that men are typically reluctant to acknowledge struggles with mental health (Arabatzoudis et al., 2021; Jarzabek et al., 2018; Patterson et al., 2022) due to societal stigma and a focus on self-reliance (Reay et al., 2023).”