AnxietyNCT04468893
Online Positive Psychology Intervention for Depression and Anxiety Due to COVID-19
A study testing Online Intervention Mental Health COVID-19 in people with Anxiety and Depression, run by Universidad Internacional de Valencia at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Sleep Disturbance
- What is being tested?
- Online Intervention Mental Health COVID-19
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 20 May 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- To have a diagnosis of psychotic disorder.
- To be receiving psychological and / or pharmacological treatment during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.
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.
Read the 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:
- Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence.
- Widespread fear Scale.
- State-Trait Anxiety Inventory (STAI).
- Generalized Anxiety Disorder 7-item (GAD-7) scale.
- Beck Depression Scale (BDI-II)
- The Pittsburgh Sleep Quality Index
- Suicidal Thoughts Scale.
- Conditions
- Anxiety, Depression, Sleep Disturbance
- Being tested
- Online Intervention Mental Health COVID-19
- Medical subject headings
- Anxiety Disorders, Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Intervention Mental Health COVID-19Behavioural
The Online Intervention Mental Health COVID-19 aims to provide to the target population a self-applied intervention based primarily on Positive Psychology, aimed at the recognition and development of strengths and virtues from the well-being approach. In addition, it is supported by elements of Cognitive Behavioral Therapy such as the components of emotion and the Antecedent-Response-Consequence (ARC) model of emotions. Elements of Behavioral Activation Therapy are also included, such as the importance of physical exercise and the relationship between physical anxiety and its effects on anxiety and depression. The intervention is made up of 15 modules that are adapted to the symptoms that the population may suffer from the global contingency caused by the COVID-19 pandemic. In addition to the Positive Psychology modules, a module with psychoeducation on grief and loss was added.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Intervention with chat | Experimental | Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression with the support of a chat service provided by therapists. Receives: Behavioral: Online Intervention Mental Health COVID-19 |
| Positive Psychology Intervention without chat | Active comparator | Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression without the support of the chat service. Receives: Behavioral: Online Intervention Mental Health COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the score of Anxiety symptoms
The State/Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluate well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistically significant decrease (P < 0.05) in the anxiety symptoms.
Measured: [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
The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified differently for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow classifying those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistically significant decrease (P < 0.05) in the depression symptoms.
Measured: [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
On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistically significant decrease (P < 0.05) in the General Anxiety symptoms.
Measured: [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
The Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence It is a brief scale with 24 symptoms corresponding to the diagnosis of PTSD, to respond by self-report, and a scale was used discretely from 1 (strongly disagree) to 4 (strongly agree). The total score was obtained by arithmetic sum. The minimum possible is 24 and the maximum 96. It is expected a statistically significant decrease (P < 0.05) in the posttraumatic stress symptoms.
Measured: [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
It is composed of seven items with options of 0 = nothing, 3 = a lot, and measures the fear in its emotional component, that is, the fear to adversities in the context and the feelings it disseminates, as well as others economic and social fears, in this case, adapted for the Sars-Cov2 pandemic. In previous studies, an acceptable internal consistency of .95 was reached. It consists of several items about the fear of being a SARS Cov2 victim in diverse contexts. In the present study, a Cronbach alpha coefficient of 0.96 was obtained. It is expected a statistically significant decrease (P < 0.05) in the widespread fear symptoms.
Measured: [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 The Pittsburgh Sleep Quality Index.
This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality Index.
Measured: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
Secondary outcomes (1)
Change on the Suicidal Thoughts Scale
This scale aims to assess the frequency of attitudes, behaviors and plans to commit suicide. It is divided into 19 items with a response option of 0 to 2, giving a total of 0 to 38 where a score equal to or greater than 10 indicates an existing risk of suicide. This scale has been validated in the Mexican population (González-Macip \& Díaz-Martínez, 2000).
Measured: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start20 May 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Internacional de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Universidad Autonoma de Ciudad Juarez
- Responsible party
- Principal investigator, Alejandro Domínguez Rodríguez, Universidad Internacional de Valencia
- Investigators
- Anabel de la Rosa Gómez, PhD, Study chair, Universidad Nacional Autonoma de MexicoPaulina Arenas Landgrave, PhD, Study chair, Universidad Nacional Autonoma de MexicoJasshel Teresa Salinas-Saldivar, MD, Study chair, Universidad Autónoma de Ciudad JuárezFlor Rocio Ramirez-Martinez, PhD, Study chair, Universidad Autónoma de Ciudad JuárezSofía Cristina Martínez Luna, MD, Study chair, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468893
- Sponsor's protocol ID
- VIU-PP
- Status last verified
- Oct 2021
- First submitted
- 10 Jul 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
Publications
Davies EB, Morriss R, Glazebrook C. Computer-delivered and web-based interventions to improve depression, anxiety, and psychological well-being of university students: a systematic review and meta-analysis. J Med Internet Res. 2014 May 16;16(5):e130. doi: 10.2196/jmir.3142.
PubMed 24836465Chávez-Valdez SM, Esparza-Del Villar OA, Ríos Velasco-Moreno L. Validation of a Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence. Journal of Aggression, Maltreatment & Trauma [Internet]. Informa UK Limited; 2020 Jan 8;1-13. DOI: http://dx.doi.org/10.1080/10926771.2019.1710635
Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
PubMed 32155789Beck AT, Steer, RA, Brown, GK. Manual for Beck Depression Inventory-II. (1996) San Antonio, TX: Psychological Corporation.
Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
PubMed 3170753Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Hishinuma ES, Miyamoto RH, Nishimura ST, Nahulu LB, Andrade NN, Makini GK Jr, Yuen NY, Johnson RC, Kim SP, Goebert DA, Guerrero AP. Psychometric properties of the state-trait anxiety inventory for Asian/Pacific-islander adolescents. Assessment. 2000 Mar;7(1):17-36. doi: 10.1177/107319110000700102.
PubMed 10668003Walsh S, Szymczynska P, Taylor SJC, Priebe S. The acceptability of an online intervention using positive psychology for depression: A qualitative study. Internet Interv. 2018 Jul 8;13:60-66. doi: 10.1016/j.invent.2018.07.003. eCollection 2018 Sep.
PubMed 30206520Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
PubMed 18388841Dominguez-Rodriguez A, Sanz-Gomez S, Gonzalez Ramirez LP, Herdoiza-Arroyo PE, Trevino Garcia LE, de la Rosa-Gomez A, Gonzalez-Cantero JO, Macias-Aguinaga V, Arenas Landgrave P, Chavez-Valdez SM. Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Form Res. 2024 Sep 30;8:e53767. doi: 10.2196/53767.
PubMed 39348893Dominguez-Rodriguez A, De La Rosa-Gomez A, Hernandez Jimenez MJ, Arenas-Landgrave P, Martinez-Luna SC, Alvarez Silva J, Garcia Hernandez JE, Arzola-Sanchez C, Acosta Guzman V. A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.
PubMed 33196449
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04468893
- Acronym / sponsor ID
- VIU-PP
- Conditions
- Anxiety, Depression, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad Internacional de ValenciaUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Universidad Autonoma de Ciudad Juarez
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence.
- Widespread fear Scale.
- State-Trait Anxiety Inventory (STAI).
- Generalized Anxiety Disorder 7-item (GAD-7) scale.
- Beck Depression Scale (BDI-II)
- The Pittsburgh Sleep Quality Index
- Suicidal Thoughts Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Intervention with chat | Experimental | Behavioral: Online Intervention Mental Health COVID-19Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression with the support of a chat service provided by therapists. |
| Positive Psychology Intervention without chat | Active comparator | Behavioral: Online Intervention Mental Health COVID-19Participants in this group will receive from 15 sessions of a Positive Psychology focused on the increase of wellbeing and sleep quality and decrease of anxiety and depression without the support of the chat service. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- To have a diagnosis of psychotic disorder.
- To be receiving psychological and / or pharmacological treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Intervention Mental Health COVID-19The Online Intervention Mental Health COVID-19 aims to provide to the target population a self-applied intervention based primarily on Positive Psychology, aimed at the recognition and development of strengths and virtues from the well-being approach. In addition, it is supported by elements of Cognitive Behavioral Therapy such as the components of emotion and the Antecedent-Response-Consequence (ARC) model of emotions. Elements of Behavioral Activation Therapy are also included, such as the importance of physical exercise and the relationship between physical anxiety and its effects on anxiety and depression. The intervention is made up of 15 modules that are adapted to the symptoms that the population may suffer from the global contingency caused by the COVID-19 pandemic. In addition to the Positive Psychology modules, a module with psychoeducation on grief and loss was added. | Behavioural | Positive Psychology Intervention with chat, Positive Psychology Intervention without chat |
Primary outcome
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.]
The State/Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluate well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistically significant decrease (P < 0.05) in the anxiety symptoms.
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.]
The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified differently for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow classifying those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistically significant decrease (P < 0.05) in the depression symptoms.
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.]
On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistically significant decrease (P < 0.05) in the General Anxiety symptoms.
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.]
The Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence It is a brief scale with 24 symptoms corresponding to the diagnosis of PTSD, to respond by self-report, and a scale was used discretely from 1 (strongly disagree) to 4 (strongly agree). The total score was obtained by arithmetic sum. The minimum possible is 24 and the maximum 96. It is expected a statistically significant decrease (P < 0.05) in the posttraumatic stress symptoms.
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.]
It is composed of seven items with options of 0 = nothing, 3 = a lot, and measures the fear in its emotional component, that is, the fear to adversities in the context and the feelings it disseminates, as well as others economic and social fears, in this case, adapted for the Sars-Cov2 pandemic. In previous studies, an acceptable internal consistency of .95 was reached. It consists of several items about the fear of being a SARS Cov2 victim in diverse contexts. In the present study, a Cronbach alpha coefficient of 0.96 was obtained. It is expected a statistically significant decrease (P < 0.05) in the widespread fear symptoms.
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.]
This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality Index.
1 secondary outcome
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.]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 24836465Davies EB, Morriss R, Glazebrook C. Computer-delivered and web-based interventions to improve depression, anxiety, and psychological well-being of university students: a systematic review and meta-analysis. J Med Internet Res. 2014 May 16;16(5):e130. doi: 10.2196/jmir.3142.
- BackgroundChávez-Valdez SM, Esparza-Del Villar OA, Ríos Velasco-Moreno L. Validation of a Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence. Journal of Aggression, Maltreatment & Trauma [Internet]. Informa UK Limited; 2020 Jan 8;1-13. DOI: http://dx.doi.org/10.1080/10926771.2019.1710635
- Background: PubMed 32155789Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
- BackgroundBeck AT, Steer, RA, Brown, GK. Manual for Beck Depression Inventory-II. (1996) San Antonio, TX: Psychological Corporation.
- Results publication: PubMed 3170753Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
- Results publication: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Results publication: PubMed 10668003Hishinuma ES, Miyamoto RH, Nishimura ST, Nahulu LB, Andrade NN, Makini GK Jr, Yuen NY, Johnson RC, Kim SP, Goebert DA, Guerrero AP. Psychometric properties of the state-trait anxiety inventory for Asian/Pacific-islander adolescents. Assessment. 2000 Mar;7(1):17-36. doi: 10.1177/107319110000700102.
- Results publication: PubMed 30206520Walsh S, Szymczynska P, Taylor SJC, Priebe S. The acceptability of an online intervention using positive psychology for depression: A qualitative study. Internet Interv. 2018 Jul 8;13:60-66. doi: 10.1016/j.invent.2018.07.003. eCollection 2018 Sep.
- Results publication: PubMed 18388841Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
- Derived from this study: PubMed 39348893Dominguez-Rodriguez A, Sanz-Gomez S, Gonzalez Ramirez LP, Herdoiza-Arroyo PE, Trevino Garcia LE, de la Rosa-Gomez A, Gonzalez-Cantero JO, Macias-Aguinaga V, Arenas Landgrave P, Chavez-Valdez SM. Evaluation and Future Challenges in a Self-Guided Web-Based Intervention With and Without Chat Support for Depression and Anxiety Symptoms During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Form Res. 2024 Sep 30;8:e53767. doi: 10.2196/53767.
- Derived from this study: PubMed 33196449Dominguez-Rodriguez A, De La Rosa-Gomez A, Hernandez Jimenez MJ, Arenas-Landgrave P, Martinez-Luna SC, Alvarez Silva J, Garcia Hernandez JE, Arzola-Sanchez C, Acosta Guzman V. A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.
- Individual participant dataSharing planned: Yes. The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabel de la Rosa Gómez, PhD study chair
Universidad Nacional Autonoma de Mexico
Paulina Arenas Landgrave, PhD study chair
Universidad Nacional Autonoma de Mexico
Jasshel Teresa Salinas-Saldivar, MD study chair
Universidad Autónoma de Ciudad Juárez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Intervention Mental Health COVID-19 in people with Anxiety and Depression, run by Universidad Internacional de Valencia at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.]). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468893, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.