Diabetes MellitusNCT07779044
Mindfulness-Based Cognitive Behavioral Program for People With Diabetes Mellitus
A study testing Mindfulness-Based Cognitive Behavioral Program in people with Diabetes Mellitus and Diabetes Mellitus ( Type 1 and Type 2), run by Center for Strategic Studies and Health Training, Syria at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus ( Type 1 and Type 2), Depressive Symptoms
- What is being tested?
- Mindfulness-Based Cognitive Behavioral Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 26 Oct 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Center for Strategic Studies and Health Training
Damascus, Damascus Governorate
About this study
Official 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.
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.
Read the 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
- Being tested
- Mindfulness-Based Cognitive Behavioral Program
- Keywords
- Diabetes mellitus, Mindfulness, Cognitive Behavioral Therapy, Quality of Life, Glycated Hemoglobin, Randomized Controlled Trial., Depression
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Behavioral ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) Level
Change in HbA1c level from baseline to immediately after completion of the intervention.
Measured: 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
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.
Measured: Baseline and 3 months (evaluated in the intervention arm).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start26 Oct 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Strategic Studies and Health Training, Syria
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ZaynALsham M AlQatrangi, BPharm, MPH, Principal investigator, Center for Strategic Studies and Health Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779044
- Sponsor's protocol ID
- CSSHT-MBCB-001
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because of privacy and confidentiality considerations and to protect the personal and health information of study participants.
Publications
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.
PubMed 32273289Newby 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.
PubMed 28506956Zarifsanaiey 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.
PubMed 32550181Yang 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.
PubMed 32848906Ni 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.
PubMed 33064926DiNardo 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.
PubMed 35346971
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07779044
- Acronym / sponsor ID
- CSSHT-MBCB-001
- Keywords
- Diabetes mellitus, Mindfulness, Cognitive Behavioral Therapy, Quality of Life, Glycated Hemoglobin, Randomized Controlled Trial., Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Center for Strategic Studies and Health Training, SyriaOther government
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Behavioral Intervention | Experimental | Behavioral: Mindfulness-Based Cognitive Behavioral ProgramParticipants received a structured mindfulness-based cognitive behavioral program consisting of 14 weekly sessions over approximately three months, in addition to routine diabetes care. |
| Routine Diabetes Care (Control) | No intervention | –Participants received routine diabetes care without any additional psychological or behavioral intervention during the study period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Mindfulness-Based Cognitive Behavioral ProgramParticipants 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. | Behavioural | Mindfulness-Based Cognitive Behavioral Intervention |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) Level
Time frame: Baseline and 3 months (post-intervention).
Change in HbA1c level from baseline to immediately after completion of the intervention.
1 secondary outcome
Within-group change in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire
Time frame: Baseline and 3 months (evaluated in the intervention arm).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Results publication: PubMed 32273289Winkley 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.
- Results publication: PubMed 28506956Newby 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.
- Results publication: PubMed 32550181Zarifsanaiey 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.
- Results publication: PubMed 32848906Yang 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.
- Results publication: PubMed 33064926Ni 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.
- Results publication: PubMed 35346971DiNardo 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because of privacy and confidentiality considerations and to protect the personal and health information of study participants.
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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.
ZaynALsham M AlQatrangi, BPharm, MPH principal investigator
Center for Strategic Studies and Health Training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Behavioral Program in people with Diabetes Mellitus and Diabetes Mellitus ( Type 1 and Type 2), run by Center for Strategic Studies and Health Training, Syria at 1 site in Syria.
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 7 inclusion and 4 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 Aug 2026. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Glycated Hemoglobin (HbA1c) Level (time frame: Baseline and 3 months (post-intervention).). 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 NCT07779044, which also lists 6 linked publications.
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 Aug 2026.