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      Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial

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          Abstract

          Background

          Many university students experience mental health problems such as anxiety and depression. To support their mental health, a transdiagnostic mobile app intervention has been developed. The intervention provides short exercises rooted in various approaches (eg, positive psychology, mindfulness, self-compassion, and acceptance and commitment therapy) that aim to facilitate adaptive emotion regulation (ER) to help students cope with the various stressors they encounter during their time at university.

          Objective

          The goals of this study are to investigate whether the intervention and its components function as intended and how participants engage with them. In addition, this study aims to monitor changes in distress symptoms and ER skills and identify relevant contextual factors that may moderate the intervention’s impact.

          Methods

          A sequential explanatory mixed methods design combining a microrandomized trial and semistructured interviews will be used. During the microrandomized trial, students (N=200) will be prompted via the mobile app twice a day for 3 weeks to evaluate their emotional states and complete a randomly assigned intervention (ie, an exercise supporting ER) or a control intervention (ie, a health information snippet). A subsample of participants (21/200, 10.5%) will participate in interviews exploring their user experience with the app and the completed exercises. The primary outcomes will be changes in emotional states and engagement with the intervention (ie, objective and subjective engagement). Objective engagement will be evaluated through log data (eg, exercise completion time). Subjective engagement will be evaluated through exercise likability and helpfulness ratings as well as user experience interviews. The secondary outcomes will include the distal outcomes of the intervention (ie, ER skills and distress symptoms). Finally, the contextual moderators of intervention effectiveness will be explored (eg, the time of day and momentary emotional states).

          Results

          The study commenced on February 9, 2023, and the data collection was concluded on June 13, 2023. Of the 172 eligible participants, 161 (93.6%) decided to participate. Of these 161 participants, 137 (85.1%) completed the first phase of the study. A subsample of participants (18/172, 10.5%) participated in the user experience interviews. Currently, the data processing and analyses are being conducted.

          Conclusions

          This study will provide insight into the functioning of the intervention and identify areas for improvement. Furthermore, the findings will shed light on potential changes in the distal outcomes of the intervention (ie, ER skills and distress symptoms), which will be considered when designing a follow-up randomized controlled trial evaluating the full-scale effectiveness of this intervention. Finally, the results and data gathered will be used to design and train a recommendation algorithm that will be integrated into the app linking students to relevant content.

          Trial Registration

          ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/46603

          Related collections

          Most cited references116

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          Using thematic analysis in psychology

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            A brief measure for assessing generalized anxiety disorder: the GAD-7.

            Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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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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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2023
                27 October 2023
                : 12
                : e46603
                Affiliations
                [1 ] Department of Psychology, Education, and Child Studies Erasmus School of Social and Behavioural Sciences Erasmus University of Rotterdam Rotterdam Netherlands
                [2 ] Dornsife Center for Economic & Social Research University of Southern California Los Angeles, CA United States
                [3 ] Keck School of Medicine University of Southern California Los Angeles, CA United States
                [4 ] Department of Psychology University of Southern California Los Angeles, CA United States
                [5 ] Department of Statistics Harvard University Boston, MA United States
                [6 ] Digital Health Center Hasso Plattner Institute for Digital Engineering University of Potsdam Potsdam Germany
                [7 ] Icahn School of Medicine at Mount Sinai Hasso Plattner Institute for Digital Health at Mount Sinai New York, NY United States
                Author notes
                Corresponding Author: Tajda Laure laure@ 123456essb.eur.nl
                Author information
                https://orcid.org/0000-0001-6854-7668
                https://orcid.org/0000-0003-1944-9126
                https://orcid.org/0000-0001-7865-6673
                https://orcid.org/0000-0002-3884-4300
                https://orcid.org/0000-0002-9966-6819
                https://orcid.org/0000-0003-4730-7838
                Article
                v12i1e46603
                10.2196/46603
                10638637
                37889525
                e8ba7ef3-7f13-4730-a32b-a53508006b8f
                ©Tajda Laure, Rutger C M E Engels, Danielle Remmerswaal, Donna Spruijt-Metz, Stefan Konigorski, Marilisa Boffo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.10.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 18 February 2023
                : 29 June 2023
                : 20 July 2023
                : 22 August 2023
                Categories
                Protocol
                Protocol

                transdiagnostic,mobile intervention,microrandomized trial,mental health,emotion regulation,university students,mobile app,mobile phone

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