Effectiveness of a Psychological Intervention on Mental Health and Sleep.

NCT05951803 | Unknown DMC

• 1 other identifier: HGMexico
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

INSOMNIA; ANXIETY; LIFE QUALITY; teleconsultation; LONG COVID

Outcome Measures

Primary Outcomes (6)

• 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

  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.

Secondary Outcomes (12)

• Sleep diary

  4 weeks after starting treatment

• Patient Health Questionnaire 9 (PHQ-9)

  4 weeks after starting treatment

• Pittsburgh Sleep Quality Index (PSQI)

  4 weeks after starting treatment

• Insomnia Severity Index (ISI)

  4 weeks after starting treatment

• SF-36 Health Survey

  4 weeks after starting treatment

Study Arms (1)

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.

Behavioral: Brief Behavioral Intervention in Insomnia

Interventions

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.

Also known as: Brief Cognitive Behavioral Therapy for Insomnia

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Horacio Balam Álvarez García

Mexico City, 15300, Mexico

Location

Related 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.

  PMID: 35633158 RESULT

Related Links

• Neurological Sequelae of COVID-19

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Horacio B Álvarez García, M.D

  Sleep Disorder Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: in data analysis, an external investigator will be asked to perform randomization and data processing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Model Details: Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 19, 2023
• Study Start: June 23, 2023
• Primary Completion: December 20, 2023
• Study Completion: February 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)