Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes; Depression
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, parallel-group, two-arm controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Depression; Treatment adherence; Cognitive behavioral therapy; Randomized controlled trial