Effectiveness of a Psychological Intervention on Mental Health and Sleep.

Depression Clinical Trial

Official title:

Effectiveness of the Brief Behavioral Intervention for Insomnia in the Teleconsultation Modality (ICBI-TC) on the Symptoms of Anxiety, Depression, Sleep Quality and Quality of Life in Insomniac Patients.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05951803
• Other study ID #: HGMexico
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: Hospital General de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: February 1, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Have a personal pathological history of diagnosis of COVID-19 (mild or severe) by PCR test or antigen test in the last 6 months.
• Present symptoms of insomnia.
• Present anxiety symptoms.
• Present symptoms of depression.
• Be between 18 and 40 years old.
• Have digital devices such as a computer, tablet or smartphone with internet access.

Exclusion Criteria:

• Being in psychological or pharmacological treatment to control insomnia, anxiety, depression, at the time of the study.
• Presenting symptoms of another sleep disorder such as obstructive sleep apnea, restless legs syndrome, or sleep disorder due to work hours (1).
• Suffering from cardiorespiratory or neurological sequelae of COVID-19 do not allow the participant to take the treatment.
• Consume psychoactive substances of abuse (Cannabis, cocaine, solvents, cannabidiol).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Insomnia Chronic
• Life Quality
• Sleep Initiation and Maintenance Disorders
• Sleep Quality

Intervention

Behavioral:
• Brief Behavioral Intervention in Insomnia
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.

Locations

Country	Name	City	State
Mexico	Horacio Balam Álvarez García	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.	1 week after starting treatment.
Primary	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.
Secondary	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
Secondary	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.	4 weeks after starting treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Neurological Sequelae of COVID-19