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NCT Number: NCT04214600

Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Behavior Behavioral Symptoms Depression Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Treatment Adherence and Compliance

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Agouza Family Medicine Center (AFMC).

Agouza, Giza Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: Baseline and 3 months

    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

Secondary outcomes

  1. Change of Depression Score on Beck's Depression Index

    Time frame: baseline and 3 months

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

    (Beck's Depression Index scores range between 1-40 where high scores mean worsening outcome and low scores mean improving outcome)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Brief Cognitive Behavioral Therapy for Adherence and Depression in Patients With Type 2 Diabetes in an Urban Primary Care Facility: Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2020
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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