NCT05951803

Effectiveness of a Psychological Intervention on Mental Health and Sleep.

Status unknown NA Last updated 19 July 2023

What this trial tests

NA trial testing Brief Behavioral Intervention in Insomnia in Insomnia Chronic in 36 participants. Status unknown.

Timeline

23 June 2023

Primary endpoint
20 December 2023

1 February 2024

Quick facts

Lead sponsor	Hospital General de Mexico
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	23 June 2023
Primary completion	20 December 2023
Estimated completion	1 February 2024
Sites	1 location across Mexico

Drugs / interventions tested

• Brief Behavioral Intervention in Insomnia

Conditions studied

• Insomnia Chronic — all drugs for Insomnia Chronic →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →
• Sleep Quality — all drugs for Sleep Quality →

Sponsor

Hospital General de Mexico

Who can join

Adults 18 to 40, any sex, with Insomnia Chronic or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Applicability and adaptation of cognitive behavior therapy for long COVID neuropsychiatric symptoms: a review with insights from ME/CFS.
   Takamatsu N, Kuga H. · · 2025 · cited 1× · PMID 41073921 · DOI 10.1186/s12879-025-11754-0