Type 2 DiabetesNCT04214600

Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

A study testing Cognitive Behavioral Therapy (CBT) in people with Type 2 Diabetes and Depression, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Type 2 Diabetes, Depression
What is being tested?: Cognitive Behavioral Therapy (CBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteEgypt
Study dates: 30 Apr 2019to 18 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Al-Agouza Family Medicine Center (AFMC).
Agouza, Giza Governorate

Other trials in Egypt

About this study

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

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.

Read the 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.

Conditions: Type 2 Diabetes, Depression
Being tested: Cognitive Behavioral Therapy (CBT)
Keywords: Type 2 diabetes, Depression, Treatment adherence, Cognitive behavioral therapy, Randomized controlled trial
Medical subject headings: Diabetes Mellitus, Type 2, Depression, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy (CBT)Behavioural
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

Study groups in NCT04214600
Study group	Role	What they receive
Cognitive Behavioral Therapy	Experimental	This group will receive four CBT sessions twice a month for two months Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
Control	No intervention	This group will be scheduled the same number of visits as a follow up for diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and 3 months

Secondary outcomes (1)

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)
Measured: baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 201918 Mar 2020

First posted2 Jan 2020
Study start30 Apr 2019
Primary completion20 Feb 2020
Study completion18 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A prospective, randomized, parallel-group, two-arm controlled trial
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04214600
Sponsor's protocol ID: CBT for T2D
Status last verified: Nov 2020
First submitted: 28 Dec 2019
Last updated: 27 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04214600
Acronym / sponsor ID: CBT for T2D
Conditions: Type 2 Diabetes, Depression
Keywords: Type 2 diabetes, Depression, Treatment adherence, Cognitive behavioral therapy, Randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 30 Apr 2019 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 18 Mar 2020 (actual)
First posted: 2 Jan 2020 (actual)
Results: Posted 16 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: A prospective, randomized, parallel-group, two-arm controlled trial

Arm	Type	Receives
Cognitive Behavioral Therapy	Experimental	Behavioral: Cognitive Behavioral Therapy (CBT)This group will receive four CBT sessions twice a month for two months
Control	No intervention	–This group will be scheduled the same number of visits as a follow up for diabetes

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Behavioural	Cognitive Behavioral Therapy

Primary outcome

Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions
Time frame: 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

1 secondary outcome

Change of Depression Score on Beck's Depression Index
Time frame: baseline and 3 months

Results and safety

Results posted to the registry on 16 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Behavioral Therapy	50	41
Control	50	36

Primary outcome: Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions

Time frame: Baseline and 3 months. Mean (Standard Error). Unit: percent

Measure	CBT Group n = 41	Control Group n = 36
Value	7.70 (0.23)	8.42 (0.25)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months (time is calculated from the first CBT session/appointment up to 3 months post-intervention).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT Group	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Control Group	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 2
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Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
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Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nadine Mansour, MD principal investigator

Al-Agouza Family Medicine Center & Faculty of Medicine, Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) in people with Type 2 Diabetes and Depression, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04214600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.