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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443139
• Other study ID #: Well-being_Online
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2023
• Source: Universidad Internacional de Valencia
• Contact: Alejandro Domínguez Rodríguez, PhD
• Phone: +521 664 471 3277
• Email: alejandro.dominguez.r[@]campusviu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Stress
• Wellbeing

Intervention

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).

Locations

Country	Name	City	State
Brazil	Universidade Federal da Bahia	Ondina
Ecuador	Universidad Internacional de Ecuador	Quito
Mexico	Tecnólogico de Monterrey	Guadalajara
Mexico	Universidad de Guadalajara	Guadalajara
Mexico	Universidad Autónoma de Ciudad Juárez	Juarez	Chihuahua
Netherlands	University of Tilburg	Tilburg
Peru	Instituto Peruano de Orientación Psicológica	Lima
Spain	Universidad Internacional de Valencia	Valencia

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Internacional de Valencia	Tilburg University, Universidad Autonoma de Ciudad Juarez, Universidad Internacional del Ecuador, Universidad Santo Tomas, University of Guadalajara

Countries where clinical trial is conducted

Brazil,  Ecuador,  Mexico,  Netherlands,  Peru,  Spain, 

References & Publications (17)

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. — View 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. — View 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. — View 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. — View 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):e580 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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 — View 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. — View 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. — View 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 — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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