Clinical trial NCT05443139: Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries
Official title: Well-being Online: Internet-based Self-administered Intervention to Reduce Anxiety and Depression Symptomatology: Randomized Clinical Trial in 7 Countries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Wellbeing
Stress
Lead sponsor: Universidad Internacional de Valencia
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Ciudad Juarez
name: University of Guadalajara
name: Universidad Internacional del Ecuador
name: Universidad Santo Tomas
name: Tilburg University
First posted: 2022-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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:

1. Interactive Intervention Group ,
2. Intervention delivered through PDF files.
3. Control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. General Anxiety Disorder with 7-items (GAD-7)
2. Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R).
3. Perceived Stress Scale (PSS-10)
4. Pittsburgh Sleep Quality scale (PSQI)
5. Action Acceptance Questionnaire II (AAQ-II)
6. The Satisfaction with Life scale
7. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
8. Perceived Deficits Questionnaire (PDQ-5)
9. The Positive and Negative Affect Schedule (PANAS)
10. Opinion on the treatment.
11. System usability scale.
12. Client Satisfaction Questionnaire (CSQ-8S)
13. The Telehealth Usability Questionnaire (TUQ)

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Completion of 100% of the basal evaluation through the form
* Residence in one of the countries participating in the study
* Fluency/ proficiency in Spanish (Mexico, Ecuador, Chile, Peru and Spain), Dutch or English (Netherlands) or Portuguese (Brazil), depending on the country.

Exclusion Criteria:

* Participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder.
* Participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, Attention-Deficit/Hyperactivity Disorder, or others.
* Participants taking medication for symptoms of depression and/or anxiety

Primary outcomes:
measure: Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Increase in Mental Psychological Well-being, the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
Secondary outcomes:
measure: Decrease in The Perceived Stress Scale (PSS-10)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Decrease in the score of The Pittsburgh Sleep Quality Index
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Decrease in the Action Acceptance Questionnaire II (AAQ-II)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Increase in The Satisfaction with Life scale
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Decrease in the Perceived Deficits Questionnaire or PDQ-5
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Decrease negative affect in the Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
measure: Increase positive affect in the Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
Other outcomes:
Locations:
city: Ondina
country: Brazil
facility: Universidade Federal da Bahia
city: Quito
country: Ecuador
facility: Universidad Internacional de Ecuador
city: Juarez
country: Mexico
facility: Universidad Autónoma de Ciudad Juárez
state: Chihuahua
city: Guadalajara
country: Mexico
facility: Tecnólogico de Monterrey
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
city: Tilburg
country: Netherlands
facility: University of Tilburg
city: Lima
country: Peru
facility: Instituto Peruano de Orientación Psicológica
city: Valencia
country: Spain
facility: Universidad Internacional de Valencia
Study officials:
affiliation: Tilburg University
name: Mercedes Almela Zamorano, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Reyna Jazmín Martínez Arriaga, PhD
role: STUDY_CHAIR
affiliation: Instituto Peruano de Orientación Psicológica
name: David Villarreal Zegarra, MD
role: STUDY_CHAIR
affiliation: Tecnologico de Monterrey
name: Leivy Patricia González Ramírez, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Adrián Antonio Cisneros Hernández, PhD
role: STUDY_CHAIR
affiliation: Independent Researcher
name: Marinna Simões Mensorio, PhD
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Rosa Olimpia Castellanos-Vargas, PhD
role: STUDY_CHAIR
affiliation: Independent Researcher
name: Rogéria Lourenço dos Santos, PhD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Joel Omar González Cantero, PhD
role: STUDY_CHAIR
affiliation: Independent Researcher
name: Viviana Sylvia Vargas Salinas, PhD
role: STUDY_CHAIR
affiliation: Universidad Internacional de Valencia
name: Joaquín Mateu Mollá, PhD
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Flor Rocío Ramírez Martínez, PhD
role: STUDY_CHAIR
affiliation: Universidad Federal da Bahia
name: Antonio Carlos Santos da Silva, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.