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      UNIPDES - An internet-based transdiagnostic intervention for college students’ psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol

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          Abstract

          University students often face significant mental health challenges, including depression, anxiety, and difficulties in adjustment, which can be exaggerated by the demands of independent living and increased life responsibilities. These challenges are often compounded by barriers to seeking help, such as stigma and limited access to university resources, which can further deteriorate students' well-being. This protocol was created to assist college students in overcoming these obstacles and to assess, in comparison to a control group, the impact of a guided and unguided online intervention platform based on transdiagnostic CBT (UNIPDES) on depression, anxiety, and adjustment levels. The calculated sample size for the study will include 330 students, and the participants will be selected from five different universities located in Türkiye. Participants will be randomly assigned to either guided, unguided, or control groups. Guided and unguided group participants will receive six weeks of intervention, and the waitlist control group will receive the unguided version of the program after twelve weeks of randomization. Assessments will take place at baseline, post-test (8 weeks post-baseline) and follow-up (12 weeks post-baseline). A Mixed ANOVA will be employed to analyze the data, with Group (Guided, Unguided, Control) as the between-subjects factor and Time (Baseline, Post-Test, Follow-Up) as the within-subjects factor, as well as to assess the interaction effect between Group and Time on the primary outcomes—changes in depression, anxiety, and adjustment levels. Additionally, students’ reasons for dropout will be assessed qualitatively. The results from this study can build evidence for the effectiveness of transdiagnostic guided and unguided internet-based intervention for treating depression, anxiety, and adjustment problems of students. UNIPDES can provide a flexible, easy-to-access, and cost-effective treatment for the problems that students commonly face. Trial registration is registered at ClinicalTrials.gov Protocol Registration and Results System (Trial number: NCT06245200).

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          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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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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              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
                Contemp Clin Trials Commun
                Contemp Clin Trials Commun
                Contemporary Clinical Trials Communications
                Elsevier
                2451-8654
                06 February 2025
                April 2025
                06 February 2025
                : 44
                : 101443
                Affiliations
                [a ]Department of Guidance and Psychological Counseling, Anadolu University, Eskisehir, Turkey
                [b ]Department of Guidance and Psychological Counseling, Middle East Technical University, Ankara, Turkey
                [c ]Department of Psychiatry, Eskisehir Osmangazi University, Eskisehir, Turkey
                [d ]Department of Guidance and Psychological Counseling, Tokat Gaziosmanpasa University, Tokat, Turkey
                [e ]Department of Guidance and Psychological Counseling, Mugla Sitki Kocman University, Mugla, Turkey
                [f ]Department of Psychology, Ankara Social Sciences University, Ankara, Turkey
                [g ]Department of Educational Sciences, Eskisehir Osmangazi University, Eskisehir, Turkey
                [h ]Department of Psychology, University of Groningen, Groningen, Netherlands
                Author notes
                Article
                S2451-8654(25)00017-1 101443
                10.1016/j.conctc.2025.101443
                11969404
                8f3fa016-2945-4fcc-b872-84e12b129496
                © 2025 The Authors

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 19 August 2024
                : 30 January 2025
                : 1 February 2025
                Categories
                Article

                internet-based intervention,transdiagnostic cognitive behavioral therapy,university students

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