Mindfulness-Based Cognitive Behavioral Program for People With Diabetes Mellitus

NCT07779044 | Completed

• 1 other identifier: CSSHT-MBCB-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated the effectiveness of a mindfulness-based cognitive behavioral program in improving quality of life and glycemic control among adults with diabetes mellitus in Damascus, Syria. The intervention combined cognitive behavioral strategies and mindfulness practices and was delivered through 14 weekly sessions over approximately three months. Quality of life was assessed using the WHOQOL-BREF, and glycemic control was assessed using glycated hemoglobin (HbA1c) levels. The study compared participants receiving the intervention with a control group receiving routine diabetes care.

Conditions

Diabetes Mellitus; Diabetes Mellitus ( Type 1 and Type 2); Depressive Symptoms

Keywords

Diabetes mellitus; Mindfulness; Cognitive Behavioral Therapy; Quality of Life; Glycated Hemoglobin; Randomized Controlled Trial.; Depression

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c) Level

  Change in HbA1c level from baseline to immediately after completion of the intervention.

  Baseline and 3 months (post-intervention).

Secondary Outcomes (1)

• Within-group change in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire

  Baseline and 3 months (evaluated in the intervention arm).

Study Arms (2)

Mindfulness-Based Cognitive Behavioral Intervention

EXPERIMENTAL

Participants received a structured mindfulness-based cognitive behavioral program consisting of 14 weekly sessions over approximately three months, in addition to routine diabetes care.

Behavioral: Mindfulness-Based Cognitive Behavioral Program

Routine Diabetes Care (Control)

NO INTERVENTION

Participants received routine diabetes care without any additional psychological or behavioral intervention during the study period.

Interventions

Mindfulness-Based Cognitive Behavioral Program BEHAVIORAL

Participants in the intervention group received a structured mindfulness-based cognitive behavioral program consisting of 14 weekly sessions delivered over approximately three months. Each session lasted approximately 90 minutes, including a 15-minute break. The program incorporated psychoeducation, cognitive restructuring, mindfulness exercises, behavioral activation, emotional regulation, relaxation techniques, coping strategies, and home practice assignments. The intervention was delivered by qualified mental health professionals in addition to routine diabetes care.

Mindfulness-Based Cognitive Behavioral Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-70 years.
• Diagnosis of type 1 or type 2 diabetes mellitus.
• Baseline HbA1c level greater than 6.5%.
• Mild to moderate depressive symptoms according to the Beck Depression - -Inventory (BDI).
• Ability to understand the study procedures and intervention instructions.
• Willingness to participate in all intervention sessions.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Severe psychiatric disorders requiring specialized psychiatric care.
• Acute medical conditions that could prevent participation in the intervention.
• Receiving regular psychotherapy or another similar psychological intervention.
• Inability to understand the intervention instructions.

Sponsors & Collaborators

• Center for Strategic Studies and Health Training, Syria: lead

Study Sites (1)

Center for Strategic Studies and Health Training

Damascus, Damascus Governorate, Syria

Location

Related Publications (6)

• Winkley K, Upsher R, Stahl D, Pollard D, Brennan A, Heller SR, Ismail K. Psychological interventions to improve glycemic control in adults with type 2 diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2020 Apr;8(1):e001150. doi: 10.1136/bmjdrc-2019-001150.

  PMID: 32273289 RESULT

• Newby J, Robins L, Wilhelm K, Smith J, Fletcher T, Gillis I, Ma T, Finch A, Campbell L, Andrews G. Web-Based Cognitive Behavior Therapy for Depression in People With Diabetes Mellitus: A Randomized Controlled Trial. J Med Internet Res. 2017 May 15;19(5):e157. doi: 10.2196/jmir.7274.

  PMID: 28506956 RESULT

• Zarifsanaiey N, Jamalian K, Bazrafcan L, Keshavarzy F, Shahraki HR. The effects of mindfulness training on the level of happiness and blood sugar in diabetes patients. J Diabetes Metab Disord. 2020 Mar 2;19(1):311-317. doi: 10.1007/s40200-020-00510-7. eCollection 2020 Jun.

  PMID: 32550181 RESULT

• Yang X, Li Z, Sun J. Effects of Cognitive Behavioral Therapy-Based Intervention on Improving Glycaemic, Psychological, and Physiological Outcomes in Adult Patients With Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Front Psychiatry. 2020 Jul 28;11:711. doi: 10.3389/fpsyt.2020.00711. eCollection 2020.

  PMID: 32848906 RESULT

• Ni YX, Ma L, Li JP. Effects of mindfulness-based intervention on glycemic control and psychological outcomes in people with diabetes: A systematic review and meta-analysis. J Diabetes Investig. 2021 Jun;12(6):1092-1103. doi: 10.1111/jdi.13439. Epub 2020 Nov 22.

  PMID: 33064926 RESULT

• DiNardo MM, Greco C, Phares AD, Beyer NM, Youk AO, Obrosky DS, Morone NE, Owen JE, Saba SK, Suss SJ, Siminerio L. Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002631. doi: 10.1136/bmjdrc-2021-002631.

  PMID: 35346971 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• ZaynALsham M AlQatrangi, BPharm, MPH

  Center for Strategic Studies and Health Training

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to either an intervention group receiving a mindfulness-based cognitive behavioral program or a control group receiving routine diabetes care. Participants remained in their assigned groups throughout the study, with assessments conducted before and after the intervention.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 21, 2026
• Study Start: October 26, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)