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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-23

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Anxiety Depression Wellbeing Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patients are not aware that there are another experimental group and a control group. The conditions of the study are only known by the researcher and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.

Study Groups

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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.

Group Type EXPERIMENTAL

Well-being online

Intervention Type BEHAVIORAL

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).

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.

Group Type EXPERIMENTAL

Well-being online

Intervention Type BEHAVIORAL

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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mercedes Almela Zamorano, PhD

Role: STUDY_CHAIR

Tilburg University

Reyna Jazmín Martínez Arriaga, PhD

Role: STUDY_CHAIR

University of Guadalajara

David Villarreal Zegarra, MD

Role: STUDY_CHAIR

Instituto Peruano de Orientación Psicológica

Leivy Patricia González Ramírez, PhD

Role: STUDY_CHAIR

Tecnologico de Monterrey

Adrián Antonio Cisneros Hernández, PhD

Role: STUDY_CHAIR

University of Guadalajara

Marinna Simões Mensorio, PhD

Role: STUDY_CHAIR

Independent Researcher

Rosa Olimpia Castellanos-Vargas, PhD

Role: STUDY_CHAIR

Universidad Autónoma de Ciudad Juárez

Rogéria Lourenço dos Santos, PhD

Role: STUDY_CHAIR

Independent Researcher

Joel Omar González Cantero, PhD

Role: STUDY_CHAIR

University of Guadalajara

Viviana Sylvia Vargas Salinas, PhD

Role: STUDY_CHAIR

Independent Researcher

Joaquín Mateu Mollá, PhD

Role: STUDY_CHAIR

Universidad Internacional de Valencia

Flor Rocío Ramírez Martínez, PhD

Role: STUDY_CHAIR

Universidad Autónoma de Ciudad Juárez

Antonio Carlos Santos da Silva, MD

Role: STUDY_CHAIR

Universidad Federal da Bahia

Locations

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