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AnxietyNCT05443139

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

A study testing Well-being online in people with Anxiety and Depression, run by Universidad Internacional de Valencia at 8 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Wellbeing
What is being tested?
Well-being online
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
8 sitesin 6 countries
Study dates
23 Dec 2022to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 6 countries.

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

8 sites in 6 countries

Mexico3 sites, 3 recruiting

  • Tecnólogico de Monterrey

    Guadalajara

    Leivy Patricia González Ramírez, PhD, leivy@tec.mx

    Not yet recruiting

  • Universidad de Guadalajara

    Guadalajara

    Reyna Jazmin Martínez Arriaga, PhD, reyna.martinez@academicos.udg.mx

    Adrián Antonio Cisneros Hernández, PhD, adrian.chernandez@academicos.udg.mx

    Not yet recruiting

  • Universidad Autónoma de Ciudad Juárez

    Juárez, Chihuahua, 32315

    Rosa Olimpia Castellanos-Vargas, MD, +52 33 1358 3137, rosa.castellanos@uacj.mx

    Flor Rocío Ramírez Martínez, PhD, rocio.ramirez@uacj.mx

    Recruiting

Other trials in Mexico

Brazil1 site, 1 recruiting

  • Universidade Federal da Bahia

    Ondina

    Antonio Carlos Santos da Silva, MD, antoniosilvapsi@gmail.com

    Not yet recruiting

Other trials in Brazil

Ecuador1 site, 1 recruiting

  • Universidad Internacional de Ecuador

    Quito

    Paulina Erika Herdoiza Arroyo, PhD, pherdoiza@uide.edu.ec

    Not yet recruiting

Other trials in Ecuador

Netherlands1 site, 1 recruiting

  • University of Tilburg

    Tilburg

    Mercedes Almela Zamorano, PhD, M.Almela@tilburguniversity.edu

    Geert van Boxtel, PhD, G.J.M.vBoxtel@tilburguniversity.edu

    Not yet recruiting

Other trials in Netherlands

Peru1 site, 1 recruiting

  • Instituto Peruano de Orientación Psicológica

    Lima

    David Villarreal Zegarra, PhD, davidvillarreal@ipops.pe

    Not yet recruiting

Other trials in Peru

Spain1 site, 1 recruiting

  • Universidad Internacional de Valencia

    Valencia

    Joaquín Mateu Mollá, PhD, Joaquin.mateu@campusviu.es

    Not yet recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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)
Being tested
Well-being online
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Well-being onlineBehavioural

    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).

Study groups in NCT05443139
Study groupRoleWhat they receive
Interactive interventionExperimentalThe 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.
Receives: Behavioral: Well-being online
non-interactive interventionExperimentalSelf-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.
Receives: Behavioral: Well-being online
Waiting List groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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

    Measured: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules

Secondary outcomes (7)

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start23 Dec 2022
  3. Primary completion23 Dec 2023 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443139
Sponsor's protocol ID
Well-being_Online
Status last verified
Jan 2023
First submitted
22 Jun 2022
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 28317414

  • 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.

    PubMed 23459093

  • 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.

    PubMed 25547522

  • 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.

    PubMed 23390882

  • 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.

    PubMed 33049431

  • 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.

    PubMed 24936656

  • 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.

    PubMed 16717171

  • 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.

    PubMed 23469262

  • 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.

    PubMed 6668417

  • 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.

    PubMed 2748771

  • 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.

    PubMed 22035996

  • 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.

    PubMed 16367493

  • 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.

    PubMed 27551243

  • 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.

    PubMed 33325828

Questions about this trial

What is this clinical trial studying?

A study testing Well-being online in people with Anxiety and Depression, run by Universidad Internacional de Valencia at 8 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Mexico, Brazil, Ecuador, Netherlands, Peru and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alejandro Domínguez Rodríguez, PhD (+521 664 471 3277, alejandro.dominguez.r@campusviu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale (time frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443139, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.

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