Depression Clinical Trial
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
Verified date | November 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 18, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al-Agouza Family Medicine Center (AFMC). | Agouza | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change of Depression Score on Beck's Depression Index | 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) |
baseline and 3 months |
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