Background: The COVID-19 pandemic represented a global public health problem that broughtconsiderable consequences to the physical and mental health of the entire population.Objective: To compare the effectiveness of the brief behavioral intervention for insomniaby teleconsultation (BBII-TC) with the brief behavioral intervention for face-to-faceinsomnia (BBII) on symptoms of insomnia, anxiety, depression, quality of sleep and lifein a sample. of patients with long COVID. Methodology: Randomized controlled trial ofequivalence 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 femaleparticipants, 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 asignificance of 0.05 and a probability error of 80%. Participants in the two groups willbe assessed with the following instruments: Sleep Diary, Patient Health Questionnaire 9,Pittsburgh Sleep Quality Index , Insomnia Severity Index, SF-36 Health Survey andGeneralized Anxiety Disorder 7; at the beginning and end of treatment; and in a follow-upat 3 months. TData analysis: The Kolmogrov-Smirnov test will be carried out to determinethe normality of the data, in case the distribution is parametric, an ANOVA of repeatedmeasures will be carried out for the comparison of data between the pre, post andmonitoring for each of the groups; in the event that the data does not have a normaldistribution, the Friedman test will be performed for the comparison of repeatedmeasures. Finally, to avoid bias in the data analysis, an external investigator will beasked 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.
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.
Other Name: Brief Cognitive Behavioral Therapy for Insomnia
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).
Horacio Balam Álvarez García
Mexico City, Mexico
Horacio B Álvarez García, M.D, Principal Investigator
Sleep Disorder Clinic