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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	26 October 2021
Main ID:	NCT04468893
Date of registration:	10/07/2020
Prospective Registration:	No
Primary sponsor:	Universidad Internacional de Valencia
Public title:	Online Positive Psychology Intervention for Depression and Anxiety Due to COVID-19
Scientific title:	Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.
Date of first enrolment:	May 20, 2020
Target sample size:	35
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT04468893
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Mexico

Contacts

Name:	Anabel de la Rosa Gómez, PhD
Address:
Telephone:
Email:
Affiliation:	Universidad Nacional Autonoma de Mexico

Name:	Flor Rocio Ramirez-Martinez, PhD
Address:
Telephone:
Email:
Affiliation:	Universidad Autónoma de Ciudad Juárez

Name:	Paulina Arenas Landgrave, PhD
Address:
Telephone:
Email:
Affiliation:	Universidad Nacional Autonoma de Mexico

Name:	Sofía Cristina Martínez Luna, MD
Address:
Telephone:
Email:
Affiliation:	Universidad Nacional Autonoma de Mexico

Name:	Jasshel Teresa Salinas-Saldivar, MD
Address:
Telephone:
Email:
Affiliation:	Universidad Autónoma de Ciudad Juárez

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety

Sleep Disturbance

Depression

Intervention(s)

Behavioral: Online Intervention Mental Health COVID-19

Primary Outcome(s)

Change in the score of The Pittsburgh Sleep Quality Index. [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Change in the score of Posttraumatic stress symptoms [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Decrease in the score of Anxiety symptoms [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Change in the symptoms of depression [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Changes in the Widespread fear Scale [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Change in the symptoms of General Anxiety Disorder [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Secondary Outcome(s)

Change on the Suicidal Thoughts Scale [Time Frame: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]]

Secondary ID(s)

VIU-PP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad Autonoma de Ciudad Juarez

Universidad Nacional Autonoma de Mexico

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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