Clinical trial NCT05951803: Effectiveness of a Psychological Intervention on Mental Health and Sleep.
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Insomnia Chronic
Anxiety
Depression
Sleep Quality
Life Quality
Keywords: INSOMNIA
ANXIETY
LIFE QUALITY
teleconsultation
LONG COVID
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2023-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Sleep diary
timeFrame: 1 week after starting treatment.
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 1 week after starting treatment.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 week after starting treatment.
measure: Insomnia Severity Index (ISI)
timeFrame: 1 week after starting treatment.
measure: SF-36 Health Survey
timeFrame: 1 week after starting treatment.
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 1 week after starting treatment.
Secondary outcomes:
measure: Sleep diary
timeFrame: 4 weeks after starting treatment
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 4 weeks after starting treatment
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks after starting treatment
measure: Insomnia Severity Index (ISI)
timeFrame: 4 weeks after starting treatment
measure: SF-36 Health Survey
timeFrame: 4 weeks after starting treatment
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 4 weeks after starting treatment
measure: Sleep diary
timeFrame: follow-up 3 months after the end of treatment
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: follow-up 3 months after the end of treatment
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: follow-up 3 months after the end of treatment
measure: Insomnia Severity Index (ISI)
timeFrame: follow-up 3 months after the end of treatment
measure: SF-36 Health Survey
timeFrame: follow-up 3 months after the end of treatment
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: follow-up 3 months after the end of treatment
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Horacio Balam Álvarez García
Study officials:
affiliation: Sleep Disorder Clinic
name: Horacio B Álvarez García, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.