Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries

Well-being Online: Internet-based Self-administered Intervention to Reduce Anxiety and Depression Symptomatology: Randomized Clinical Trial in 7 Countries

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Wellbeing; Stress; Anxiety
• Intervention / Treatment: Behavioral: Well-being online

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)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Dominguez Rodriguez, PhD; Phone Number: +521 664 471 3277; Email: alejandro.dominguez.r@campusviu.es
• Study Contact Backup: Name: Paulina Erika Herdoiza-Arroyo, PhD; Phone Number: +593 95 862 5451; Email: pherdoiza@uide.edu.ec

Study Locations

• Brazil
  • Ondina, Brazil
    • Not yet recruiting
    • Universidade Federal da Bahia
    • Contact: Antonio Carlos Santos da Silva, MD; Email: antoniosilvapsi@gmail.com
• Ecuador
  • Quito, Ecuador
    • Not yet recruiting
    • Universidad Internacional de Ecuador
    • Contact: Paulina Erika Herdoiza Arroyo, PhD; Email: pherdoiza@uide.edu.ec
• Mexico
  • Guadalajara, Mexico
    • Not yet recruiting
    • Tecnologico de Monterrey
    • Contact: Leivy Patricia González Ramírez, PhD; Email: leivy@tec.mx
  • Guadalajara, Mexico
    • Not yet recruiting
    • Universidad de Guadalajara
    • Contact: Reyna Jazmin Martínez Arriaga, PhD; Email: reyna.martinez@academicos.udg.mx
    • Contact: Adrián Antonio Cisneros Hernández, PhD; Email: adrian.chernandez@academicos.udg.mx
    • Sub-Investigator: Joel Omar González Cantero, PhD
  • Chihuahua
    • Juarez, Chihuahua, Mexico, 32315
      • Recruiting
      • Universidad Autonoma de Ciudad Juarez
      • Contact: Rosa Olimpia Castellanos-Vargas, MD; Phone Number: +52 33 1358 3137; Email: rosa.castellanos@uacj.mx
      • Contact: Flor Rocío Ramírez Martínez, PhD; Email: rocio.ramirez@uacj.mx
• Netherlands
  • Tilburg, Netherlands
    • Not yet recruiting
    • University of Tilburg
    • Contact: Mercedes Almela Zamorano, PhD; Email: M.Almela@tilburguniversity.edu
    • Contact: Geert van Boxtel, PhD; Email: G.J.M.vBoxtel@tilburguniversity.edu
• Peru
  • Lima, Peru
    • Not yet recruiting
    • Instituto Peruano de Orientación Psicológica
    • Contact: David Villarreal Zegarra, PhD; Email: davidvillarreal@ipops.pe
• Spain
  • Valencia, Spain
    • Not yet recruiting
    • Universidad Internacional de Valencia
    • Contact: Joaquín Mateu Mollá, PhD; Email: Joaquin.mateu@campusviu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive intervention; 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.	Behavioral: Well-being online; 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).
Experimental: non-interactive intervention; 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.	Behavioral: Well-being online; 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).
No Intervention: Waiting List group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Universidad Internacional de Valencia
• Collaborators: University of Guadalajara; Universidad Autonoma de Ciudad Juarez; Universidad Internacional del Ecuador; Universidad Santo Tomas; Tilburg University
• Investigators: Study Chair: Mercedes Almela Zamorano, PhD, Tilburg University; Study Chair: Reyna Jazmín Martínez Arriaga, PhD, University of Guadalajara; Study Chair: David Villarreal Zegarra, MD, 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 Autonoma de Ciudad Juarez; 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 Autonoma de Ciudad Juarez; Study Chair: Antonio Carlos Santos da Silva, MD, Universidad Federal da Bahia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2022
• Primary Completion (Anticipated): December 23, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: Well-being_Online

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Through the servers of the journal(s) where we will publish the articles.
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No