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

Universidad Internacional de Valencia

Status: Enrolling

Conditions: Wellbeing; Depression; Anxiety; Stress

Treatments: Behavioral: Well-being online

Study type: Interventional

Funder types: Other

Identifiers

NCT05443139

Well-being_Online

Details and patient eligibility

About

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.

Full 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:

General Anxiety Disorder with 7-items (GAD-7) Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R). Perceived Stress Scale (PSS-10) Pittsburgh Sleep Quality scale (PSQI) Action Acceptance Questionnaire II (AAQ-II) The Satisfaction with Life scale The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Perceived Deficits Questionnaire (PDQ-5) The Positive and Negative Affect Schedule (PANAS) Opinion on the treatment. System usability scale. Client Satisfaction Questionnaire (CSQ-8S) The Telehealth Usability Questionnaire (TUQ)

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Interactive intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Well-being online

non-interactive intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Well-being online

Waiting List group

No Intervention group

Description:

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.