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      A CBT-based mobile intervention as an adjunct treatment for adolescents with symptoms of depression: a virtual randomized controlled feasibility trial

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          Abstract

          Background

          High rates of adolescent depression demand for more effective, accessible treatment options. A virtual randomized controlled trial was used to assess the feasibility and acceptability of a 5-week, self-guided, cognitive behavioral therapy (CBT)-based mobile application, Spark, compared to a psychoeducational mobile application (Active Control) as an adjunct treatment for adolescents with depression during the COVID-19 pandemic.

          Methods

          A community sample aged 13–21, with self-reported symptoms of depression, was recruited nationwide. Participants were randomly assigned to use either Spark or Active Control (N Spark = 35; N Active Control = 25). Questionnaires, including the PHQ-8 measuring depression symptoms, completed before, during, and immediately following completion of the intervention, evaluated depressive symptoms, usability, engagement, and participant safety. App engagement data were also analyzed.

          Results

          60 eligible adolescents (female = 47) were enrolled in 2 months. 35.6% of those expressing interest were consented and all enrolled. Study retention was high (85%). Spark users rated the app as usable (System Usability Scale mean = 80.67) and engaging (User Engagement Scale-Short Form mean = 3.62). Median daily use was 29%, and 23% completed all levels. There was a significant negative relationship between behavioral activations completed and change in PHQ-8. Efficacy analyses revealed a significant main effect of time, F = 40.60, p < .001, associated with decreased PHQ-8 scores over time. There was no significant Group × Time interaction (F = 0.13, p = .72) though the numeric decrease in PHQ-8 was greater for Spark (4.69 vs. 3.56). No serious adverse events or adverse device effects were reported for Spark users. Two serious adverse events reported in the Active Control group were addressed per our safety protocol.

          Conclusion

          Recruitment, enrollment, and retention rates demonstrated study feasibility by being comparable or better than other mental health apps. Spark was highly acceptable relative to published norms. The study's novel safety protocol efficiently detected and managed adverse events. The lack of significant difference in depression symptom reduction between Spark and Active Control may be explained by study design and study design factors. Procedures established during this feasibility study will be leveraged for subsequent powered clinical trials evaluating app efficacy and safety.

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          Most cited references94

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          The PHQ-9: validity of a brief depression severity measure.

          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            The brief resilience scale: assessing the ability to bounce back.

            While resilience has been defined as resistance to illness, adaptation, and thriving, the ability to bounce back or recover from stress is closest to its original meaning. Previous resilience measures assess resources that may promote resilience rather than recovery, resistance, adaptation, or thriving. To test a new brief resilience scale. The brief resilience scale (BRS) was created to assess the ability to bounce back or recover from stress. Its psychometric characteristics were examined in four samples, including two student samples and samples with cardiac and chronic pain patients. The BRS was reliable and measured as a unitary construct. It was predictably related to personal characteristics, social relations, coping, and health in all samples. It was negatively related to anxiety, depression, negative affect, and physical symptoms when other resilience measures and optimism, social support, and Type D personality (high negative affect and high social inhibition) were controlled. There were large differences in BRS scores between cardiac patients with and without Type D and women with and without fibromyalgia. The BRS is a reliable means of assessing resilience as the ability to bounce back or recover from stress and may provide unique and important information about people coping with health-related stressors.
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              Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population.

              The 7-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire that proved valid in primary care. However, the GAD-7 was not yet validated in the general population and thus far, normative data are not available. To investigate reliability, construct validity, and factorial validity of the GAD-7 in the general population and to generate normative data. Nationally representative face-to-face household survey conducted in Germany between May 5 and June 8, 2006. Five thousand thirty subjects (53.6% female) with a mean age (SD) of 48.4 (18.0) years. The survey questionnaire included the GAD-7, the 2-item depression module from the Patient Health Questionnaire (PHQ-2), the Rosenberg Self-Esteem Scale, and demographic characteristics. Confirmatory factor analyses substantiated the 1-dimensional structure of the GAD-7 and its factorial invariance for gender and age. Internal consistency was identical across all subgroups (alpha = 0.89). Intercorrelations with the PHQ-2 and the Rosenberg Self-Esteem Scale were r = 0.64 (P < 0.001) and r = -0.43 (P < 0.001), respectively. As expected, women had significantly higher mean (SD) GAD-7 anxiety scores compared with men [3.2 (3.5) vs. 2.7 (3.2); P < 0.001]. Normative data for the GAD-7 were generated for both genders and different age levels. Approximately 5% of subjects had GAD-7 scores of 10 or greater, and 1% had GAD-7 scores of 15 or greater. Evidence supports reliability and validity of the GAD-7 as a measure of anxiety in the general population. The normative data provided in this study can be used to compare a subject's GAD-7 score with those determined from a general population reference group.
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                Author and article information

                Contributors
                Journal
                Front Digit Health
                Front Digit Health
                Front. Digit. Health
                Frontiers in Digital Health
                Frontiers Media S.A.
                2673-253X
                23 May 2023
                2023
                : 5
                : 1062471
                Affiliations
                [ 1 ]Research Department, Limbix Health , San Francisco, CA, United States
                [ 2 ]Science Department, Limbix Health , San Francisco, CA, United States
                [ 3 ]Product Department, Limbix Health , San Francisco, CA, United States
                [ 4 ]Content Department, Limbix Health , San Francisco, CA, United States
                Author notes

                Edited by: Tim Campellone, Woebot Labs Inc., United States

                Reviewed by: Katrina Prior, The University of Sydney, Australia Arkers Kwan Ching Wong, Hong Kong Polytechnic University, Hong Kong SAR, China

                [* ] Correspondence: Shana A. Hall shana@ 123456limbix.com Jessica I. Lake jess@ 123456limbix.com
                [ † ]

                These authors share first authorship

                [ ‡ ]

                These authors share last authorship

                Article
                10.3389/fdgth.2023.1062471
                10262850
                37323125
                c888ae4f-3132-4c5e-b0e5-9be559038493
                © 2023 Kulikov, Crosthwaite, Hall, Flannery, Strauss, Vierra, Koepsell, Lake and Padmanabhan.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 05 October 2022
                : 27 April 2023
                Page count
                Figures: 7, Tables: 7, Equations: 2, References: 105, Pages: 0, Words: 0
                Funding
                Funded by: Spark was funded in part by NIH
                Award ID: 1R44MH125636
                Product development of Spark was funded in part by NIH grant R44MH125636.
                Categories
                Digital Health
                Clinical Trial
                Custom metadata
                Personalized Medicine

                cognitive behavioral therapy,digital therapeutics,adolescent depression,feasibility,mhealth,mental health

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