Effectiveness of a Psychological Intervention on Mental Health and Sleep.

Hospital General de Mexico

Status: Invitation-only

Conditions: Sleep Quality; Life Quality; Depression; Anxiety; Insomnia Chronic

Treatments: Behavioral: Brief Behavioral Intervention in Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05951803

HGMexico

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Brief Behavioral Intervention in Insomnia through Tele-Consultation (BBII-TC)

Other group

Description:

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.

Treatment:

Behavioral: Brief Behavioral Intervention in Insomnia