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

U

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

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.

Trial contacts and locations

8

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Central trial contact

Alejandro Domínguez Rodríguez, PhD; Paulina Erika Herdoiza-Arroyo, PhD

Data sourced from clinicaltrials.gov

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