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Background: The COVID-19 pandemic represented a global public health problem that brought considerable consequences to the physical and mental health of the entire population. Objective: To compare the effectiveness of the brief behavioral intervention for insomnia by teleconsultation (BBII-TC) with the brief behavioral intervention for face-to-face insomnia (BBII) on symptoms of insomnia, anxiety, depression, quality of sleep and life in a sample. of patients with long COVID. Methodology: Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months. The sample will be composed of male or female participants, in an age range of 18 to 40 years. The sample size was calculated, obtaining a total of 52 participants, the expected effect size is .40, with a significance of 0.05 and a probability error of 80%. Participants in the two groups will be assessed with the following instruments: Sleep Diary, Patient Health Questionnaire 9, Pittsburgh Sleep Quality Index , Insomnia Severity Index, SF-36 Health Survey and Generalized Anxiety Disorder 7; at the beginning and end of treatment; and in a follow-up at 3 months. TData analysis: The Kolmogrov-Smirnov test will be carried out to determine the normality of the data, in case the distribution is parametric, an ANOVA of repeated measures will be carried out for the comparison of data between the pre, post and monitoring for each of the groups; in the event that the data does not have a normal distribution, the Friedman test will be performed for the comparison of repeated measures. Finally, to avoid bias in the data analysis, an external investigator will be asked to perform the randomization and data processing.
Once the sample is composed, the participants will be randomized in a simple computerized way to one of the two groups. A structured clinical interview will be carried out, then they will be given the sleep diary and the instruments will be applied to measure the degree of symptoms of sleep disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Behavioral Intervention in Insomnia through Tele-Consultation (BBII-TC) | Other | Brief therapy organized into four sessions, lasting 60 minutes each, where behavioral therapy techniques are taught (stimulus control, sleep restriction, progressive muscle relaxation, sleep hygiene). The teleconsultation modality is given through the ZOOM platform synchronously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Intervention in Insomnia | Behavioral | Weekly intervention of 4 sessions where behavior therapy techniques are administered, such as stimulus control, sleep hygiene, sleep restriction and progressive muscle relaxation. Each session lasts 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy | 1 week after starting treatment. |
| Patient Health Questionnaire 9 (PHQ-9) | Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89. | 1 week after starting treatment. |
| Pittsburgh Sleep Quality Index (PSQI) | Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78. | 1 week after starting treatment. |
| Insomnia Severity Index (ISI) | Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient. | 1 week after starting treatment. |
| SF-36 Health Survey |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy | 4 weeks after starting treatment |
| Patient Health Questionnaire 9 (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horacio B Álvarez García, M.D | Sleep Disorder Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horacio Balam Álvarez García | Mexico City | 15300 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35633158 | Result | Ahmad SJ, Feigen CM, Vazquez JP, Kobets AJ, Altschul DJ. Neurological Sequelae of COVID-19. J Integr Neurosci. 2022 Apr 6;21(3):77. doi: 10.31083/j.jin2103077. |
| Label | URL |
|---|---|
| Neurological Sequelae of COVID-19 | View source |
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The database will be kept by the researchers and will be shared with other researchers upon request.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months
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in data analysis, an external investigator will be asked to perform randomization and data processing.
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|
It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93.
| 1 week after starting treatment. |
| Generalized Anxiety Disorder 7 (GAD-7) | Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8. | 1 week after starting treatment. |
Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89. |
| 4 weeks after starting treatment |
| Pittsburgh Sleep Quality Index (PSQI) | Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78. | 4 weeks after starting treatment |
| Insomnia Severity Index (ISI) | Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient. | 4 weeks after starting treatment |
| SF-36 Health Survey | It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93. | 4 weeks after starting treatment |
| Generalized Anxiety Disorder 7 (GAD-7) | Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8. | 4 weeks after starting treatment |
| Sleep diary | Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy | follow-up 3 months after the end of treatment |
| Patient Health Questionnaire 9 (PHQ-9) | Self-applied questionnaire that assesses the presence and severity of depressive symptoms. It is made up of 9 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range of 0 to 27. These scores are interpreted from 0 to 5 (mild), 6 to 10 (moderate), 11 to 15 (moderately severe) and 16 to 27. (severe). Within its psychometric properties, the original version has a high internal consistency with a Cronbach's alpha of 0.86, while the Mexican version was 0.89. | follow-up 3 months after the end of treatment |
| Pittsburgh Sleep Quality Index (PSQI) | Self-administered questionnaire that assesses sleep quality. It is made up of 24 reagents; the total score has a range of 0 to 21 points; where a total score less than 5 points indicates good sleep quality and a score greater than 5 points is interpreted as poor sleep quality. In the Mexican population, he obtained a Cronbach's Alpha of 0.78. | follow-up 3 months after the end of treatment |
| Insomnia Severity Index (ISI) | Self-administered questionnaire of 8 items on a Likert scale from 0 (none) to 4 (Very severe), which assesses nighttime symptoms, sleep quality, and daytime symptoms of insomnia; it has a reliability of 0.82 in its original version; and it has similar psychometric indicators in a version validated in Spanish. In its version for the Mexican population, it obtained a 0.84 reliability coefficient. | follow-up 3 months after the end of treatment |
| SF-36 Health Survey | It is a self-applicable instrument that evaluates the quality of life of people, it is divided into 8 dimensions associated with health such as: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. Each of these dimensions is evaluated in a different way, being a Likert scale between 4 and 5 response options and dichotomous (yes/no) in others. Within the Mexican version, the psychometric properties showed a high internal consistency with a Cronbach's alpha of 0.93. | follow-up 3 months after the end of treatment |
| Generalized Anxiety Disorder 7 (GAD-7) | Self-administered questionnaire that assesses the presence and severity of generalized anxiety symptoms. It is made up of 7 items on a Likert scale that goes from 0 (not at all) to 3 (almost every day). The evaluation consists of the sum of the scores of each item having a range from 0 to 21. It is interpreted that a score greater than 10 is considered as generalized anxiety. Within its psychometric properties, the version translated into Spanish has a high internal consistency with a Cronbach's alpha of 0.8. | follow-up 3 months after the end of treatment |
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |