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| Name | Class |
|---|---|
| Universidad Autonoma de Ciudad Juarez | OTHER |
| University of Guadalajara | OTHER |
| Universidad Internacional del Ecuador | OTHER |
| Universidad Santo Tomas |
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This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.
Anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. Furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system.
Considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. Thus, the online modality of the intervention presented in this project can benefit a significant number of people in Mexico, Ecuador, Chile, Brazil, Peru, the Netherlands and Spain. The online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach.
The participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. The self-report measures will include the following Psychometrics:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive intervention | Experimental | The participants will receive a self-applied intervention composed by 10 sessions following a multi component structure. The participants assigned to this condition will count with interactive resources such as Videos, Online Forum and Exercises embedded on the platform. |
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| non-interactive intervention | Experimental | Self-administered treatment with 10 sessions will be provided through care manuals in PDF format within the same web platform. Participants in this group will receive a manual within the platform with the same content of the sessions as the experimental group but in PDF format. |
|
| Waiting List group | No Intervention | The control condition consists of a 30-day waiting list, in which participants will not be able to access the interventions. After the waiting process, they will be given access to either the interactive intervention or the non-interactive intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Well-being online | Behavioral | Multi component Intervention composed 10 sessions following a structure based on Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Positive Psychology (PP), Mindfulness and Behavioral Activation Therapy (BAT). |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale | Center for Epidemiologic Studies Depression (CES-D) is a structured self-report scale for evaluation depression symptoms. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where ^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P < 0.05) in depression symptoms. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale | Is a short scale with items that measure the severity of generalized anxiety disorder symptoms. Responses are based on symptoms perceived during the past week. The questions of this scale are answered in Likert format with 0-3, where the maximum total score is 21. A score between 0 and 4 points indicates that anxiety is not perceived, and a score between 15 and 21 is an indicator of perceived severe anxiety.It is expected a statistically significant decrease (P < 0.05) in anxiety symptoms. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Increase in Mental Psychological Well-being, the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | It consists of 14 items, including hedonic (i.e. affects, life satisfaction) and eudaimonic (i.e. positive relationships, psychological functioning) items, which together measure mental well-being. Each item is responded in a Likert scale (i.e. 1 = none of the time to 5 = all of the time) and the total score ranges from 14 to 70. The higher the score, the higher the mental well-being | Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in The Perceived Stress Scale (PSS-10) | The PSS-10 has ten items with 5 response options (0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Often, 4 = Very often). The interpretation is that the higher the score, the higher the stress level | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Domínguez Rodríguez, PhD | Contact | +521 664 471 3277 | alejandro.dominguez.r@campusviu.es | |
| Paulina Erika Herdoiza-Arroyo, PhD | Contact | +593 95 862 5451 | pherdoiza@uide.edu.ec |
| Name | Affiliation | Role |
|---|---|---|
| Mercedes Almela Zamorano, PhD | Tilburg University | Study Chair |
| Reyna Jazmín Martínez Arriaga, PhD | University of Guadalajara | Study Chair |
| David Villarreal Zegarra, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal da Bahia | Not yet recruiting | Ondina | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Piqueras Rodríguez, J. A., Martínez González, A. E., Ramos Linares, V., Rivero Burón, R., García López, L. J., & Oblitas Guadalupe, L. A. (2008). Ansiedad, depresión y salud (Anxiety, depression and health). Suma Psicológica, 15, 43-74. | ||
| 28317414 | Background | Podlogar MC, Rogers ML, Stanley IH, Hom MA, Chiurliza B, Joiner TE. Anxiety, depression, and the suicidal spectrum: a latent class analysis of overlapping and distinctive features. Cogn Emot. 2018 Nov;32(7):1464-1477. doi: 10.1080/02699931.2017.1303452. Epub 2017 Mar 20. | |
| 23459093 |
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The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
This data will be available approximately in September 2023 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
Through the servers of the journal(s) where we will publish the articles.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| OTHER |
| Tilburg University | OTHER |
The Well-being Online study will implement a randomized controlled trial at five points for the intervention groups and six evaluation periods for the control group: 1)pretest, 2)middle of the treatment, 3) post-test, 4) follow up at 3 months and 5) follow up at six months. 6) Participants in the control group will be re-assigned to the intervention group after the post-waiting list period.
The study will implement a three-arm design (parallel group), comparing:
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The patients are not aware that there are another experimental group and a control group. The conditions of the study are only known by the researcher and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.
| Decrease in the score of The Pittsburgh Sleep Quality Index | This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality measure. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Decrease in the Action Acceptance Questionnaire II (AAQ-II) | The instrument measures experiential avoidance and psychological inflexibility. It consists of 7 items that are answered using a 7-point Likert scale. The items ask about the unwillingness to experience unwanted emotions and thoughts (e.g., "I am afraid of my feelings", "I worry about not being able to control my worries and feelings") and the inability to be in the present moment. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Increase in The Satisfaction with Life scale | It consists of 5 items in which participants must indicate how much they agree with each question, with a response option in Likert format from 1 (strongly disagree) to 7 (strongly agree). The scores range from 5 to 35, where higher scores indicate greater satisfaction with life. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Decrease in the Perceived Deficits Questionnaire or PDQ-5 | The scale asks about problems of functioning in daily life associated with possible cognitive problems, with a 5-point Likert-type response format, ranging from 1- Rarely to 5-Always. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Decrease negative affect in the Positive and Negative Affect Schedule (PANAS) | PANAS comprises two groups consisting of ten terms of either positive or negative affect. Partcipants assess their intensity on a 5-point scale ranging from "not at all" to "extremely", indicating the range of emotions at a given moment or over a period of time, and their chronic or transient nature. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Increase positive affect in the Positive and Negative Affect Schedule (PANAS) | PANAS comprises two groups consisting of ten terms of either positive or negative affect. Partcipants assess their intensity on a 5-point scale ranging from "not at all" to "extremely", indicating the range of emotions at a given moment or over a period of time, and their chronic or transient nature. | 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules |
| Instituto Peruano de Orientación Psicológica |
| Study Chair |
| Leivy Patricia González Ramírez, PhD | Tecnologico de Monterrey | Study Chair |
| Adrián Antonio Cisneros Hernández, PhD | University of Guadalajara | Study Chair |
| Marinna Simões Mensorio, PhD | Independent Researcher | Study Chair |
| Rosa Olimpia Castellanos-Vargas, PhD | Universidad Autónoma de Ciudad Juárez | Study Chair |
| Rogéria Lourenço dos Santos, PhD | Independent Researcher | Study Chair |
| Joel Omar González Cantero, PhD | University of Guadalajara | Study Chair |
| Viviana Sylvia Vargas Salinas, PhD | Independent Researcher | Study Chair |
| Joaquín Mateu Mollá, PhD | Universidad Internacional de Valencia | Study Chair |
| Flor Rocío Ramírez Martínez, PhD | Universidad Autónoma de Ciudad Juárez | Study Chair |
| Antonio Carlos Santos da Silva, MD | Universidad Federal da Bahia | Study Chair |
| Universidad Internacional de Ecuador | Not yet recruiting | Quito | Ecuador |
|
| Universidad Autónoma de Ciudad Juárez | Recruiting | Juárez | Chihuahua | 32315 | Mexico |
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| Tecnólogico de Monterrey | Not yet recruiting | Guadalajara | Mexico |
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| Universidad de Guadalajara | Not yet recruiting | Guadalajara | Mexico |
|
| University of Tilburg | Not yet recruiting | Tilburg | Netherlands |
|
| Instituto Peruano de Orientación Psicológica | Not yet recruiting | Lima | Peru |
|
| Universidad Internacional de Valencia | Not yet recruiting | Valencia | Spain |
|
| Background |
| Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31. |
| 25547522 | Background | A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24. |
| 23390882 | Background | Bolier L, Haverman M, Westerhof GJ, Riper H, Smit F, Bohlmeijer E. Positive psychology interventions: a meta-analysis of randomized controlled studies. BMC Public Health. 2013 Feb 8;13:119. doi: 10.1186/1471-2458-13-119. |
| 33049431 | Background | Gal E, Stefan S, Cristea IA. The efficacy of mindfulness meditation apps in enhancing users' well-being and mental health related outcomes: a meta-analysis of randomized controlled trials. J Affect Disord. 2021 Jan 15;279:131-142. doi: 10.1016/j.jad.2020.09.134. Epub 2020 Oct 7. |
| 24936656 | Background | Ekers D, Webster L, Van Straten A, Cuijpers P, Richards D, Gilbody S. Behavioural activation for depression; an update of meta-analysis of effectiveness and sub group analysis. PLoS One. 2014 Jun 17;9(6):e100100. doi: 10.1371/journal.pone.0100100. eCollection 2014. |
| 16717171 | Result | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |
| 23469262 | Result | Carleton RN, Thibodeau MA, Teale MJ, Welch PG, Abrams MP, Robinson T, Asmundson GJ. The center for epidemiologic studies depression scale: a review with a theoretical and empirical examination of item content and factor structure. PLoS One. 2013;8(3):e58067. doi: 10.1371/journal.pone.0058067. Epub 2013 Mar 1. |
| 6668417 | Result | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 2748771 | Result | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| 22035996 | Result | Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25. |
| 16367493 | Result | Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. |
| 27551243 | Result | Strober LB, Binder A, Nikelshpur OM, Chiaravalloti N, DeLuca J. The Perceived Deficits Questionnaire: Perception, Deficit, or Distress? Int J MS Care. 2016 Jul-Aug;18(4):183-90. doi: 10.7224/1537-2073.2015-028. |
| 33325828 | Result | Sevilla-Gonzalez MDR, Moreno Loaeza L, Lazaro-Carrera LS, Bourguet Ramirez B, Vazquez Rodriguez A, Peralta-Pedrero ML, Almeda-Valdes P. Spanish Version of the System Usability Scale for the Assessment of Electronic Tools: Development and Validation. JMIR Hum Factors. 2020 Dec 16;7(4):e21161. doi: 10.2196/21161. |
| 3397865 | Result | Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. |
| 18042300 | Result | Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. |