Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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General Anxiety Disorder with 7-items (GAD-7)
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Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R).
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Perceived Stress Scale (PSS-10)
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Pittsburgh Sleep Quality scale (PSQI)
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Action Acceptance Questionnaire II (AAQ-II)
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The Satisfaction with Life scale
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Ryff's Scale of Psychological Well-being
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Perceived Deficits Questionnaire (PDQ-5)
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Opinion on the treatment.
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System usability scale.
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Client Satisfaction Questionnaire (CSQ-8S)
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The Telehealth Usability Questionnaire (TUQ)
Study Design
Arms and Interventions
| 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).
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| 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. |
Outcome Measures
Primary Outcome Measures
- Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale [1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules]
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.
- Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale [1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules]
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.
Secondary Outcome Measures
- 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]
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
- 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]
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.
- 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]
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.
- 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]
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.
- Increase in the Ryff's Scale of Psychological Well-being (SPWB) [1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules]
The instrument has a response format with scores ranging from 1 (strongly disagree) to 6 (strongly agree); it has six factors: self-acceptance (1), positive relationships with others (2), autonomy (3), mastery of the environment (4), purpose in life (5) and personal growth (6).
- 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]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older
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Completion of 100% of the basal evaluation through the form
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Residence in one of the countries participating in the study
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Fluency/ proficiency in Spanish (Mexico, Ecuador, Chile, Peru and Spain), Dutch or English (Netherlands) or Portuguese (Brazil), depending on the country.
Exclusion Criteria:
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Participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder.
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Participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, Attention-Deficit/Hyperactivity Disorder, or others.
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Participants taking medication for symptoms of depression and/or anxiety
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidad Santo Tomás | Talca | Chile | ||
| 2 | Universidad Internacional de Ecuador | Quito | Ecuador | ||
| 3 | Universidad Autónoma de Ciudad Juárez | Juarez | Chihuahua | Mexico | 32315 |
| 4 | Tecnólogico de Monterrey | Guadalajara | Mexico | ||
| 5 | Universidad de Guadalajara | Guadalajara | Mexico | ||
| 6 | University of Tilburg | Tilburg | Netherlands | ||
| 7 | Instituto Peruano de Orientación Psicológica | Lima | Peru | ||
| 8 | Universidad Internacional de Valencia | Valencia | Spain |
Sponsors and Collaborators
- Universidad Internacional de Valencia
- Universidad Autonoma de Ciudad Juarez
- University of Guadalajara
- 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 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 Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- Gál É, Ștefan 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. Review.
- 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. Epub 2012 Jul 31.
- 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.
- Well-being_Online