Mindfulness-Based Cognitive Behavioral Program for People With Diabetes Mellitus
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Damascus Governorate
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Damascus, Damascus Governorate, Syrie
- Center for Strategic Studies and Health Training
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Mindfulness-Based Cognitive Behavioral Intervention
Participants received a structured mindfulness-based cognitive behavioral program consisting of 14 weekly sessions over approximately three months, in addition to routine diabetes care.
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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.
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Aucune intervention: Routine Diabetes Care (Control)
Participants received routine diabetes care without any additional psychological or behavioral intervention during the study period.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Glycated Hemoglobin (HbA1c) Level
Délai: Baseline and 3 months (post-intervention).
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Change in HbA1c level from baseline to immediately after completion of the intervention.
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Baseline and 3 months (post-intervention).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Within-group change in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire
Délai: Baseline and 3 months (evaluated in the intervention arm).
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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.
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Baseline and 3 months (evaluated in the intervention arm).
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: ZaynALsham M AlQatrangi, BPharm, MPH, Center for Strategic Studies and Health Training
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CSSHT-MBCB-001
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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