Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

NCT ID: NCT04214600

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2020-03-18

Brief Summary

Despite the significant relationship between depression and diabetes, there are few published studies testing the effect of cognitive behavioral therapy in improving disease outcomes among diabetics in primary healthcare settings in Egypt. The study aims at assessing the efficacy of cognitive behavioral therapy combined with diabetes education versus control receiving diabetes education alone in helping patients with Type 2 Diabetes and depressive symptoms to achieve glycemic control and compliance to treatment.

Detailed Description

The psychological status of diabetic patients impacts their health behavior and clinical outcomes significantly. Psychological interventions are important tools to amending health behavior in Type 2 Diabetes (T2D). Cognitive Behavioral Therapy (CBT) has been an effective non-pharmacologic treatment for a wide variety of mental disorders such as depression, anxiety, post-traumatic stress disorder, eating disorders, and schizophrenia. The therapeutic approach promotes coping capabilities against difficult situations. It targets a change in negative patterns of cognition and associated behaviors and promotes emotional regulation.

Depression in diabetic patients is under-recognized. It is estimated that 44% of depressed patients are recognized by practitioners. Such lack of recognition is attributed to poor diabetic outcomes. There is a growing body of research that explores the effectiveness of this psychological technique in managing chronic physical diseases. Despite the success of CBT in managing psychiatric morbidities, research on its use in the treatment of diabetes is limited and with varying results. Moreover, the majority of studies that have investigated the burden of depression in T2D have been carried out in high-income countries, but little is done in the Middle East and North Africa (MENA) region especially Egypt.

Conditions

Type 2 Diabetes; Depression

Keywords

Type 2 diabetes; Depression; Treatment adherence; Cognitive behavioral therapy; Randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy

This group will receive four CBT sessions twice a month for two months

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:

Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills

Control

This group will be scheduled the same number of visits as a follow up for diabetes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy (CBT)

Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:

Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients meeting the American Diabetes Association (ADA) criteria for T2D (glycated hemoglobin (HbA1c) ≥6.5%, fasting glucose ≥126mg/dL) with diagnosis confirmed by the participants' medical clinicians.
• Participants aged more than 35 years; ambulatory; able to give informed consent; and able to obtain reliable information.
• Eligible patients will be screened for depressive symptoms using the Beck Depression Inventory (BDI). They will be included if they score 11-30 based on BDI (Mild mood disturbance to Moderate depression).

Exclusion Criteria

• Participants will be excluded if they have type I diabetes and psychiatric disorders other than mood or personality disorders. Depressed patients on treatment for depression will not be included.
• Suicidal patients and those diagnosed with major depressive disorder will be referred to a psychiatrist.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Mansour

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Agouza Family Medicine Center & Faculty of Medicine, Cairo University

Locations

Al-Agouza Family Medicine Center (AFMC).

Agouza, Giza Governorate, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CBT for T2D

Identifier Type: -

Identifier Source: org_study_id