Insomnia ChronicNCT05951803
Effectiveness of a Psychological Intervention on Mental Health and Sleep.
A study testing Brief Behavioral Intervention in Insomnia in people with Insomnia Chronic and Anxiety, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Insomnia Chronic, Anxiety, Depression
- What is being tested?
- Brief Behavioral Intervention in Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jun 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Insomnia Chronic, Anxiety, Depression, Sleep Quality, Life Quality
- Being tested
- Brief Behavioral Intervention in Insomnia
- Keywords
- INSOMNIA, ANXIETY, LIFE QUALITY, teleconsultation, LONG COVID
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Intervention in InsomniaBehavioural
Also called Brief Cognitive Behavioral Therapy for 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief Behavioral Intervention in Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week after starting treatment.
Secondary outcomes (12)
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
Measured: 4 weeks 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.
Measured: 4 weeks 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.
Measured: 4 weeks 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.
Measured: 4 weeks 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.
Measured: 4 weeks 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.
Measured: 4 weeks after starting treatment
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
Measured: follow-up 3 months after the end of 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.
Measured: follow-up 3 months after the end of 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.
Measured: follow-up 3 months after the end of 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.
Measured: follow-up 3 months after the end of 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.
Measured: follow-up 3 months after the end of 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.
Measured: follow-up 3 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start23 Jun 2023
- Primary completion20 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Horacio Balam ALvarez Garcia, Hospital General de Mexico
- Investigators
- Horacio B Álvarez García, M.D, Principal investigator, Sleep Disorder Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951803
- Sponsor's protocol ID
- HGMexico
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database will be kept by the researchers and will be shared with other researchers upon request.
Publications
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.
PubMed 35633158
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05951803
- Acronym / sponsor ID
- HGMexico
- Conditions
- Insomnia Chronic, Anxiety, Depression, Sleep Quality, Life Quality
- Keywords
- INSOMNIA, ANXIETY, LIFE QUALITY, teleconsultation, LONG COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Intervention in Insomnia through Tele-Consultation (BBII-TC) | Other | Behavioral: Brief Behavioral Intervention in InsomniaBrief 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Intervention in InsomniaAlso: Brief Cognitive Behavioral Therapy for InsomniaWeekly 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. | Behavioural | Brief Behavioral Intervention in Insomnia through Tele-Consultation (BBII-TC) |
Primary outcome
Sleep diary
Time frame: 1 week after starting treatment.
Self-registration format subjectively evaluates the number of sleepless nights, subjective sleep quality, number of awakenings per night, sleep onset latency, and sleep efficacy
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 1 week after starting treatment.
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 week after starting treatment.
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.
Insomnia Severity Index (ISI)
Time frame: 1 week after starting treatment.
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.
SF-36 Health Survey
Time frame: 1 week after starting treatment.
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.
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: 1 week after starting treatment.
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.
12 secondary outcomes
Sleep diary
Time frame: 4 weeks after starting treatment
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 4 weeks after starting treatment
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks after starting treatment
Insomnia Severity Index (ISI)
Time frame: 4 weeks after starting treatment
SF-36 Health Survey
Time frame: 4 weeks after starting treatment
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: 4 weeks after starting treatment
Sleep diary
Time frame: follow-up 3 months after the end of treatment
Patient Health Questionnaire 9 (PHQ-9)
Time frame: follow-up 3 months after the end of treatment
Pittsburgh Sleep Quality Index (PSQI)
Time frame: follow-up 3 months after the end of treatment
Insomnia Severity Index (ISI)
Time frame: follow-up 3 months after the end of treatment
SF-36 Health Survey
Time frame: follow-up 3 months after the end of treatment
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: follow-up 3 months after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Results publication: PubMed 35633158Ahmad 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.
- Neurological Sequelae of COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: No. The database will be kept by the researchers and will be shared with other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horacio B Álvarez García, M.D principal investigator
Sleep Disorder Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Intervention in Insomnia in people with Insomnia Chronic and Anxiety, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary (time frame: 1 week after starting treatment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.