A pilot study on the efficacy of Mindfulness-Based Stress Reduction (MBSR) for improving mental health and metabolic profile among diabetes patients living in regional and rural north Queensland: A randomized clinical trial

Not Applicable

• Conditions: Diabetes; Mental health; Metabolic health; Metabolic and Endocrine - Diabetes; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12624000376549
• Lead Sponsor: Townsville Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-04-02
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who 1) are aged 18 years or over; 2) have been diagnosed with Type 1 or Type 2 diabetes for at least 6 months; 3) have a stable antidiabetic medication dosage; and 4) speak fluent English and have attained at least a Year Seven reading ability.

Exclusion Criteria

Patients who 1) experience significant comorbidities including cardiac, respiratory, or renal failures; 2) malignancies other than basal cell carcinoma; 3) current substance dependence (as measured by DSM-V criteria); 4) current psychotic disorder (e.g., schizophrenia, bipolar disorder); 5) prominent current suicidal ideation; 6) change in dosage, or began new, psychotropic medication in the previous 2 months; 7) a severe cognitive disorder (e.g., dementia or severe traumatic brain injury); 8) a clinically significant unstable or severe medical condition; and 9) prior participation in a MBSR program.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression [The Patient Health Questionnaire (PHQ-9) Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.];Stress[This will be assessed as a composite outcome including the Perceived Stress Scale (PSS), The Diabetes Distress Scale (DDS) , and hair cortisol. Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.];Metabolic profile [This will be assessed as a composite outcome that includes blood test for HbA1c level, inflammatory cytokines, BGM, lipid profile, blood pressure; and anthropometric measurements including body weight (measured by scale measure) , waist circumference (measured tape measure by and body mass index. Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.]

Secondary Outcome Measures

Name	Time	Method
Sleep[The Global Sleep Assessment Questionnaire (GASQ) Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.];Pain[The Numeric Pain Rating Scale Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.];Mindfulness[The Mindful Attention Awareness Scale (MAAS) Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.];Anxiety (this is an additional [primary outcome).[The Generalised Anxiety Disorder Scale (GAD-7) Baseline, 4-week and 6-week during the intervention, post-completion of 8-week MBSR program, and three month follow up.]