Clinical trial NCT04214600: Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes
Official title: Brief Cognitive Behavioral Therapy for Adherence and Depression in Patients With Type 2 Diabetes in an Urban Primary Care Facility: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Depression
Keywords: Type 2 diabetes
Depression
Treatment adherence
Cognitive behavioral therapy
Randomized controlled trial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, parallel-group, two-arm controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change of Depression Score on Beck's Depression Index
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Agouza
country: Egypt
facility: Al-Agouza Family Medicine Center (AFMC).
state: Giza
Study officials:
affiliation: Al-Agouza Family Medicine Center & Faculty of Medicine, Cairo University
name: Nadine Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References: