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      Internet-based self-administered intervention to reduce anxiety and depression symptomatology and improve well-being in 7 countries: protocol of a randomized control trial

      methods-article
      1 , * , , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 4 , 10 , 2 , 2 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19
      Frontiers in Psychology
      Frontiers Media S.A.
      randomized controlled trial, anxiety, depression, internet-based intervention, self-guided, well-being

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          Abstract

          Background

          Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants.

          Methods

          A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis.

          Discussion

          This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe.

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          Most cited references103

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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 Pittsburgh sleep quality index: A new instrument for psychiatric practice and research

            Despite the prevalence of sleep complaints among psychiatric patients, few questionnaires have been specifically designed to measure sleep quality in clinical populations. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" sleepers (healthy subjects, n = 52) and "poor" sleepers (depressed patients, n = 54; sleep-disorder patients, n = 62). Acceptable measures of internal homogeneity, consistency (test-retest reliability), and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.
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              A Global Measure of Perceived Stress

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                Author and article information

                Contributors
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                Journal
                Front Psychol
                Front Psychol
                Front. Psychol.
                Frontiers in Psychology
                Frontiers Media S.A.
                1664-1078
                07 May 2024
                2024
                : 15
                : 1279847
                Affiliations
                [1] 1Department of Psychology, Health and Technology, University of Twente , Enschede, Netherlands
                [2] 2Faculty of Medicine, Health and Life Sciences, School of Psychology, Universidad Internacional del Ecuador , Quito, Ecuador
                [3] 3School of Medicine and Health Sciences, Tecnologico de Monterrey , Guadalajara, Mexico
                [4] 4Departamento de Clínicas de Salud Mental, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara , Guadalajara, Mexico
                [5] 5Instituto Peruano de Orientación Psicológica , Lima, Peru
                [6] 6Escuela de Psicología, Universidad Continental , Lima, Peru
                [7] 7Federal University of Bahia , Salvador, Brazil
                [8] 8Departamento de Ciencias del Comportamiento, Centro Universitario de los Valles, Universidad de Guadalajara , Ameca, Mexico
                [9] 9Departamento de Psicología Social, Universitat de València , Valencia, Spain
                [10] 10Independent researcher , São Paulo, Brazil
                [11] 11Health Sciences Area, Valencian International University , Valencia, Spain
                [12] 12Rectory, Autonomous University of Ciudad Juarez , Juarez, Mexico
                [13] 13Plan estratégico de Juarez , Juarez, Mexico
                [14] 14Department of Psychology, European University of Valencia , Valencia, Spain
                [15] 15Department of Nursing and Physiotherapy, University of Lleida , Lleida, Spain
                [16] 16Faculty of Psychology and Humanities, University San Sebastián , Valdivia, Chile
                [17] 17Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay , Santiago, Chile
                [18] 18School of Psychology, University Adolfo Ibañez , Santiago, Chile
                [19] 19Health Sciences Department, Autonomous University of Ciudad Juarez , Juarez, Mexico
                Author notes

                Edited by: Mojtaba Vaismoradi, Nord University, Norway

                Reviewed by: Fei Zhao, Northwest University for Nationalities, China

                Pierluigi Diotaiuti, University of Cassino, Italy

                Abbas Mardani, Zanjan University of Medical Sciences, Iran

                *Correspondence: Alejandro Dominguez-Rodriguez, a.dominguezrodriguez@ 123456utwente.nl
                Article
                10.3389/fpsyg.2024.1279847
                11107906
                38774723
                80addfeb-0096-4f8c-abfc-b41659bef434
                Copyright © 2024 Dominguez-Rodriguez, Herdoiza-Arroyo, González-Ramírez, Martínez-Arriaga, Villarreal-Zegarra, Silva, González-Cantero, Vargas Salinas, Mensorio, Cisneros Hernández, Lourenço dos Santos, Nieto Ramos, Albán-Terán, Mateu-Mollá, Ramírez-Martínez, Colmenero Guadián, Martínez-Rubio, Langer, Araya and Castellanos-Vargas.

                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
                : 18 August 2023
                : 01 April 2024
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 111, Pages: 16, Words: 12821
                Funding
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. The Autonomous University of Ciudad Juárez provided the funds to develop the Well-being Online Intervention. The funding body had no role in the study design, writing of the manuscript, or the decision to submit the paper to a specific journal.
                Categories
                Psychology
                Study Protocol
                Custom metadata
                Psychology for Clinical Settings

                Clinical Psychology & Psychiatry
                randomized controlled trial,anxiety,depression,internet-based intervention,self-guided,well-being

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