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

NCT05443139 | Unknown DMC

• 1 other identifier: Well-being_Online
• Study Type: interventional
• Target: 200
• Locations: 6 countries
• Sites: 8

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.

Conditions

Anxiety; Depression; Wellbeing; Stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Decrease in The Perceived Stress Scale (PSS-10)

  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

  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)

  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

  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

  1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules

Study Arms (3)

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.

Behavioral: Well-being online

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.

Behavioral: Well-being online

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.

Interventions

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).

Interactive intervention; non-interactive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Internacional de Valencia: lead
• Universidad Autonoma de Ciudad Juarez: collaborator
• University of Guadalajara: collaborator
• Universidad Internacional del Ecuador: collaborator
• Universidad Santo Tomas: collaborator
• Tilburg University: collaborator

Study Sites (8)

Universidade Federal da Bahia

Ondina, Brazil

NOT YET RECRUITING

Universidad Internacional de Ecuador

Quito, Ecuador

NOT YET RECRUITING

Universidad Autónoma de Ciudad Juárez

Juárez, Chihuahua, 32315, Mexico

RECRUITING

Tecnólogico de Monterrey

Guadalajara, Mexico

NOT YET RECRUITING

Universidad de Guadalajara

Guadalajara, Mexico

NOT YET RECRUITING

University of Tilburg

Tilburg, Netherlands

NOT YET RECRUITING

Instituto Peruano de Orientación Psicológica

Lima, Peru

NOT YET RECRUITING

Universidad Internacional de Valencia

Valencia, Spain

NOT YET RECRUITING

Related Publications (17)

• 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.

  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.

  PMID: 28317414 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.

  PMID: 23459093 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.

  PMID: 25547522 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.

  PMID: 23390882 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.

  PMID: 33049431 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.

  PMID: 24936656 BACKGROUND

• 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.

  PMID: 16717171 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.

  PMID: 23469262 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.

  PMID: 6668417 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.

  PMID: 2748771 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.

  PMID: 22035996 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.

  PMID: 16367493 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.

  PMID: 27551243 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.

  PMID: 33325828 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.

  PMID: 3397865 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.

  PMID: 18042300 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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 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

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: December 23, 2022
• Primary Completion: December 23, 2023
• Study Completion: November 1, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Locations

PE (1); ME (3); EC (1); BR (1); NL (1); ES (1)