Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT04468893
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Positive Psychology Intervention for Depression and Anxiety Due to COVID-19
Sponsor:
Universidad Internacional de Valencia
Organization:
Study Overview
Official Title:
Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the effectiveness of a Positive Psychology intervention, that is focused on increasing the positive emotions and strengths of human beings. It is compared to the effectiveness of an online treatment with the change of the same participants before and after receiving the treatment accompanied by a chat support service vs. the treatment solely. The changes are being assessed through worldwide validated measures such as psychometrics.
Detailed Description:
The outbreak of the new coronavirus 2019 (COVID-19) has become a public health emergency of international concern that has not only threatened people's physical health but has also affected mental health and psychological well-being. Among the several symptoms can be observed an affected sleep quality, symptoms of posttraumatic stress disorder, anxiety, depression, and complicated grief, among others.
To provide treatment in such conditions where face-to-face sessions are not possible, and the number of patients surpasses the number of available therapists it will be implemented an online intervention based on positive psychology. positive Psychology has been defined as the scientific study of positive experiences, positive individual traits, the institutions that facilitate their development, and the programs that help to improve the quality of life of the individuals while preventing or reducing the incidence of psychopathology.
The online intervention system Mental Health Platform COVID-19 will be delivered in 15 modules interconnected, implemented one per session. The objective of this study is to assess the efficacy and moderators of change of an intervention program based on the Positive Psychology approach for the reduction of anxious and depressive symptoms, increase of positive emotions and sleep quality during and after the contingency by COVID-19 by means of a telepsychology.
This study will have two intervention groups, one that will receive the online intervention plus a chat added element. The chat service will be provided by clinical therapists through the Tawk application where participants can receive help if they have questions about a module and its activities or a technical problem, in addition to other functions. The comparison group will receive the same intervention however will not include the chat service. In both conditions, the participants will be measured pre and post. The subjective measures will include the following psychometrics:
1. Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence.
2. Widespread fear Scale.
3. State-Trait Anxiety Inventory (STAI).
4. Generalized Anxiety Disorder 7-item (GAD-7) scale.
5. Beck Depression Scale (BDI-II)
6. The Pittsburgh Sleep Quality Index
7. Suicidal Thoughts Scale.
To provide treatment in such conditions where face-to-face sessions are not possible, and the number of patients surpasses the number of available therapists it will be implemented an online intervention based on positive psychology. positive Psychology has been defined as the scientific study of positive experiences, positive individual traits, the institutions that facilitate their development, and the programs that help to improve the quality of life of the individuals while preventing or reducing the incidence of psychopathology.
The online intervention system Mental Health Platform COVID-19 will be delivered in 15 modules interconnected, implemented one per session. The objective of this study is to assess the efficacy and moderators of change of an intervention program based on the Positive Psychology approach for the reduction of anxious and depressive symptoms, increase of positive emotions and sleep quality during and after the contingency by COVID-19 by means of a telepsychology.
This study will have two intervention groups, one that will receive the online intervention plus a chat added element. The chat service will be provided by clinical therapists through the Tawk application where participants can receive help if they have questions about a module and its activities or a technical problem, in addition to other functions. The comparison group will receive the same intervention however will not include the chat service. In both conditions, the participants will be measured pre and post. The subjective measures will include the following psychometrics:
1. Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence.
2. Widespread fear Scale.
3. State-Trait Anxiety Inventory (STAI).
4. Generalized Anxiety Disorder 7-item (GAD-7) scale.
5. Beck Depression Scale (BDI-II)
6. The Pittsburgh Sleep Quality Index
7. Suicidal Thoughts Scale.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: