N/A
N=100
Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes
Type 2 Diabetes · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04214600 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions — 7.70; 8.42 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy (CBT) (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions |
7.70; 8.42 | — |
| SECONDARY Change of Depression Score on Beck's Depression Index |
12.25; 16.49 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04214600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.