Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

NCT04214600 | Completed Results DMC

• 1 other identifier: CBT for T2D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions

  Assess the effect of the CBT combined with diabetes education versus control receiving diabetes education alone on glycemic measures of patients with T2D and depression

  Baseline and 3 months

Secondary Outcomes (1)

• Change of Depression Score on Beck's Depression Index

  baseline and 3 months

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy (CBT)

Control

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy (CBT) 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

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al-Agouza Family Medicine Center (AFMC).

Agouza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Treatment Adherence and Compliance

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Shortage of HbA1c preparation kits. Retention of participants was a challenge although visits were scheduled at patients' convenience. The study was conducted in one healthcare center. Long term effect of the intervention was not examined.

Results Point of Contact

• Title: Dr. Nadine Mansour
• Organization: Cairo University

lotfynadine@gmail.com

(+2)01001482455- 01001465719

Study Officials

• Nadine Mansour, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding of patients and all members of the research team (except for the researcher conducting the CBT intervention) will be carried out throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A prospective, randomized, parallel-group, two-arm controlled trial

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: April 30, 2019
• Primary Completion: February 20, 2020
• Study Completion: March 18, 2020
• Last Updated: November 27, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-11

Locations

EG (1)