Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia

NCT ID: NCT06264661

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2022-11-30

Brief Summary

Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia

Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico

• Patients with type 2 diabetes mellitus
• Age between 40 and 60 years
• Present Insomnia based on the criteria of The Diagnostic and Diagnostic Manual Statistics of Mental Disorders (DSM-V) which defines insomnia such as predominant dissatisfaction with the quantity or quality of sleep, associated with one (or more) of the following symptoms: a) Difficulty starting the dream,or b) Difficulty maintaining sleep, characterized by awakenings frequent and c) Waking up early in the morning with inability to return to sleep; with clinically significant distress or social impairment, work, educational, academic, behavioral or other important areas of operation, at least three nights a week, for a minimum of three months even with favorable sleeping conditions.
• Sign an informed consent letter and agree to participate in the study.
• Accept taking a blood sample pre and post intervention
• HbA1c level above 6.1% (120 mg/dL;7 mmol/L) or BMI less than 34.9 units

Exclusion Criteria

• Do not agree to sign the informed consent
• Have a previous psychiatric diagnosis
• Have neurological disorders
• Be diagnosed with type 1 diabetes mellitus or BMI greater than 35 units
• Missing more than 20% of the sessions (2 sessions)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

OTHER

Sponsor Role: lead

Responsible Party

Nadia Mabel Pérez Vielma

professor and researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM 006/22-R

Identifier Type: -

Identifier Source: org_study_id