Clinical trial NCT04468893: Online Positive Psychology Intervention for Depression and Anxiety Due to COVID-19
Official title: Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Sleep Disturbance
Lead sponsor: Universidad Internacional de Valencia
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: Universidad Autonoma de Ciudad Juarez
First posted: 2020-07-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the intervention group that receives the treatment in addition to a chat service and the other is the comparison group that will receive treatment without the chat service. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* To have access to a communication device with access to the internet (computer, tablet, and mobile).
* To have a valid email address.
* To have basic digital skills in the use of an operational system and internet browsing.
* To understand Spanish since all the contents are in this language

Exclusion Criteria:

* To have a diagnosis of psychotic disorder.
* To be receiving psychological and / or pharmacological treatment during the study

Primary outcomes:
measure: Decrease in the score of Anxiety symptoms
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
measure: Change in the symptoms of depression
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
measure: Change in the symptoms of General Anxiety Disorder
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
measure: Change in the score of Posttraumatic stress symptoms
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
measure: Changes in the Widespread fear Scale
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
measure: Change in the score of The Pittsburgh Sleep Quality Index.
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
Secondary outcomes:
measure: Change on the Suicidal Thoughts Scale
timeFrame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
Other outcomes:
Locations:
city: Juarez
country: Mexico
facility: Universidad Autónoma de Ciudad Juárez
state: Chihuahua
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Anabel de la Rosa Gómez, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Paulina Arenas Landgrave, PhD
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Jasshel Teresa Salinas-Saldivar, MD
role: STUDY_CHAIR
affiliation: Universidad Autónoma de Ciudad Juárez
name: Flor Rocio Ramirez-Martinez, PhD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Sofía Cristina Martínez Luna, MD
role: STUDY_CHAIR
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