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Completed

NCT Number: NCT07779044

Mindfulness-Based Cognitive Behavioral Program for People With Diabetes Mellitus

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Strategic Studies and Health Training

Damascus, Damascus Governorate, Syria

About this study

Diabetes mellitus is a chronic condition that requires continuous self-management and may negatively affect psychological well-being, quality of life, and glycemic control. Psychological distress and difficulties in coping with diabetes may interfere with self-care behaviors and disease management.

This randomized controlled trial was conducted to evaluate the effectiveness of an integrated mindfulness-based cognitive behavioral program among adults with diabetes mellitus in Damascus, Syria. The intervention was designed to address psychological and behavioral factors that may affect diabetes self-management. It combined cognitive behavioral techniques, including psychoeducation, cognitive restructuring, behavioral activation, and coping strategies, with mindfulness exercises, relaxation techniques, emotional regulation, and home practice.

A total of 40 participants completed the study, with 20 participants allocated to the intervention group and 20 to the control group. Eligible adults with type 1 or type 2 diabetes were randomly assigned to either the intervention group or the control group. Participants in the intervention group received 14 weekly counseling sessions over approximately three months, with each session lasting approximately 90 minutes. The control group received routine diabetes care without an additional psychological intervention.

Quality of life was assessed using the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF), which evaluates physical health, psychological health, social relationships, and environmental domains. Glycemic control was assessed using glycated hemoglobin (HbA1c) measured before and after the intervention. The Beck Depression Inventory (BDI) was used during screening to identify participants with mild to moderate depressive symptoms and determine eligibility; it was not used as an outcome measure.

The study aimed to determine whether the integrated mindfulness-based cognitive behavioral program could improve quality of life and glycemic control compared with routine diabetes care

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire

    Time frame: Baseline and immediately after completion of the intervention.

    Change in quality of life from baseline to immediately after completion of the intervention, measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. The overall quality of life score ranges from 0 to 100, with higher scores indicating better quality of life. The questionnaire also assesses four domains: physical health, psychological health, social relationships, and environment. Each domain score ranges from 4 to 20, with higher scores indicating better quality of life.

  2. Change in Glycated Hemoglobin (HbA1c) Level

    Time frame: Baseline and immediately after completion of the intervention.

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

Sponsors and collaborators

Lead sponsor

Center for Strategic Studies and Health Training, Syria

Other Gov

Registry information

Official study title

Effectiveness of A Mindfulness-Based Cognitive Behavioral Program on Quality of Life and Glycosylated Hemoglobin Control of People With Diabetes: A Randomized Controlled Trial in Damascus, Syria.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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