Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04214600
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Depression	Behavioral: Cognitive Behavioral Therapy (CBT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective, randomized, parallel-group, two-arm controlled trialA prospective, randomized, parallel-group, two-arm controlled trial
• Masking: Single (Participant)
• 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 30, 2019
• Actual Primary Completion Date: Feb 20, 2020
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy This group will receive four CBT sessions twice a month for two months	Behavioral: 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. 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
No Intervention: Control This group will be scheduled the same number of visits as a follow up for diabetes

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Agouza Family Medicine Center (AFMC).	Agouza	Giza	Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Nadine Mansour, MD, Al-Agouza Family Medicine Center & Faculty of Medicine, Cairo University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 17, 2020

More Information

Publications

None provided.

• Responsible Party: Nadine Mansour, Dr, Cairo University
• ClinicalTrials.gov Identifier: NCT04214600
• Other Study ID Numbers: CBT for T2D
• First Posted: Jan 2, 2020
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nadine Mansour, Dr, Cairo University: Type 2 diabetes; Depression; Treatment adherence; Cognitive behavioral therapy; Randomized controlled trial
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Cognitive Behavioral Therapy	Control
Arm/Group Description	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. 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	This group will be scheduled the same number of visits as a follow up for diabetes
Period Title: Overall Study
STARTED	50	50
COMPLETED	41	36
NOT COMPLETED	9	14

Baseline Characteristics

Arm/Group Title	Cognitive Behavioral Therapy	Control	Total
Arm/Group Description	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	This group will be scheduled the same number of visits as a follow up for diabetes.	Total of all reporting groups
Overall Participants	50	50	100
Age, Customized (Count of Participants)
35-44	5 10%	12 24%	17 17%
45-54	19 38%	18 36%	37 37%
45-64	11 22%	6 12%	17 17%
≥65	15 30%	14 28%	29 29%
Sex: Female, Male (Count of Participants)
Female	16 32%	15 30%	31 31%
Male	34 68%	35 70%	69 69%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions
Description	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

Outcome Measure Data

Analysis Population Description

Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post-intervention assessment.

Arm/Group Title	CBT Group	Control Group
Arm/Group Description	Participants received four Cognitive Behavioral Therapy sessions and diabetes education	Participants received diabetes education only
Measure Participants	41	36
Mean (Standard Error) [percent]	7.70 (0.23)	8.42 (0.25)

2. Secondary Outcome

Title	Change of Depression Score on Beck's Depression Index
Description	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

Outcome Measure Data

Analysis Population Description

Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post intervention assessment.

Arm/Group Title	CBT Group	Control Group
Arm/Group Description	Participants received four Cognitive Behavioral Therapy sessions and diabetes education	Participants received four diabetes education only
Measure Participants	41	36
Mean (Standard Error) [score on a scale]	12.25 (1.09)	16.49 (1.16)

Adverse Events

Time Frame	6 months (time is calculated from the first CBT session/appointment up to 3 months post-intervention).
Arm/Group Title	CBT Group		Control Group
Arm/Group Description	Participants received four CBT sessions and diabetes education		Participants received diabetes education only
All Cause Mortality
	CBT Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	CBT Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	CBT Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

Shortage of HbA1c preparation kits. Retention of participants was a challenge although visits were scheduled at patients' convenience. The study was conducted in one healthcare center. Long term effect of the intervention was not examined.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.