Depression, Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Depression, Treatment adherence, Cognitive behavioral therapy, Randomized controlled trial
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT)
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
A prospective, randomized, parallel-group, two-arm controlled trial
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of Depression Score on Beck's Depression Index | 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) |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy This group will receive four CBT sessions twice a month for two months
Cognitive Behavioral Therapy (CBT): 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 and 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 | 50 |
| Control This group will be scheduled the same number of visits as a follow up for diabetes. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 14 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy | Control | Total |
|---|---|---|---|
| Age, Customized Age interval 35-44 | 5 Participants | 12 Participants | 17 Participants |
| Age, Customized Age interval 45-54 | 19 Participants | 18 Participants | 37 Participants |
| Age, Customized Age interval 45-64 | 11 Participants | 6 Participants | 17 Participants |
| Age, Customized Age interval ≥65 | 15 Participants | 14 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 34 Participants | 35 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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
Time frame: Baseline and 3 months
Population: Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post-intervention assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT Group | Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions | 7.70 percent | Standard Error 0.23 |
| Control Group | Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions | 8.42 percent | Standard Error 0.25 |
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)
Time frame: baseline and 3 months
Population: Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post intervention assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT Group | Change of Depression Score on Beck's Depression Index | 12.25 score on a scale | Standard Error 1.09 |
| Control Group | Change of Depression Score on Beck's Depression Index | 16.49 score on a scale | Standard Error 1.16 |