Depressive Symptoms, Diabetes Mellitus, Diabetes Mellitus ( Type 1 and Type 2)
Conditions
Keywords
Diabetes mellitus, Mindfulness, Cognitive Behavioral Therapy, Quality of Life, Glycated Hemoglobin, Randomized Controlled Trial., Depression
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.
Detailed description
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
Interventions
BEHAVIORALMindfulness-Based Cognitive Behavioral Program
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.
Sponsors
Center for Strategic Studies and Health Training, Syria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) Level | Baseline and 3 months (post-intervention). | Change in HbA1c level from baseline to immediately after completion of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Change in quality of life from baseline to 3 months (post-intervention), measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire within the intervention group. The questionnaire assesses four primary domains: Physical Health, Psychological Health, Social Relationships, and Environment, with domain scores ranging from 4 to 20, where higher scores indicate better quality of life. An overall quality of life index is also calculated on a scale of 0 to 100, with higher values reflecting superior general quality of life. |
Countries
Syria
Contacts
PRINCIPAL_INVESTIGATORZaynALsham M AlQatrangi, BPharm, MPH
Center for Strategic Studies and Health Training
Outcome results
None listed