Clinical trial NCT06345196: Motivational Interviewing Applied to Individuals With Diabetes
Official title: The Effect of Motivational Interviewing on Well-being, Stress and Difficulties in Individuals With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motivational Interviewing
Stress
Well-Being, Psychological
Diabetes Mellitus
Type2diabetes
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data.

Detailed description: Approximately 537 million people worldwide have diabetes and it is estimated to reach 643 million in 2030 and 783 million in 2045. In this context, the prevalence of diabetes is increasing and 1.5 million people die each year due to diabetes. Diabetes is a chronic disease that requires complex care activities and multiple decision-making related to self-management. In particular, the most common is type 2 diabetes in adults, which occurs when the body becomes resistant to insulin or does not produce enough insulin. Daily self-management of the disease is necessary for individuals with type 2 diabetes to achieve healthy glucose levels, minimize the effects of the disease on their daily lives and reduce the risk of developing complications. The main elements of self-management in individuals with diabetes include taking medication, maintaining a healthy diet, regular physical activity, foot care and monitoring blood glucose for insulin users.

Managing diabetes is a process that requires continuous effort and adherence to multiple health behaviors, and many patients have difficulty managing this chronic condition. This situation increases stress in individuals and causes deterioration in well-being and psychosocial status.

Stress in individuals with diabetes can negatively affect problem-solving skills and lead to poor self-management behavior. However, it has also been reported that positive well-being in individuals with diabetes has a good effect on disease management (better glucose control, reduced disease burden, increased work productivity and reduced mortality). However, individuals with type 2 diabetes have been found to have lower well-being than the general population. Therefore, it is important to develop stress coping strategies and support positive well-being for people with diabetes.

The control of diabetes depends on the individual's healthy lifestyle behaviors and disease management as well as the pharmacological treatment option. However, many systematic reviews show that motivational interviewing is an effective intervention method in the treatment of diabetes. These studies have shown that it has positive effects on diet and weight management, diabetes self-management, medication adherence, and glycemic control in individuals with diabetes. Looking at the literature, although less stress and positive well-being are important to overcome the difficulties in disease management in individuals with diabetes, studies on supporting stress and positive well-being in type 2 diabetes patients are limited. In this context, this study will be conducted to determine the effect of motivational interviewing applied to individuals with diabetes on well-being, stress and difficulties.

Eligibility criteria: Inclusion Criteria:

* volunteering to participate in the study,
* Having a diagnosis of Type 2 Diabetes,
* HbA1C values outside the normal range for the last 2-3 months.

Exclusion Criteria:

* Having a diagnosis of Type 1 Diabetes,
* Having limitations in reading and understanding Turkish.

Primary outcomes:
measure: Change in coping with stress
timeFrame: 4 weeks
Secondary outcomes:
measure: State of Well-Being Change
timeFrame: 4 weeks
Other outcomes:
measure: Changing Strength and Difficulties in Diabetes
timeFrame: 4 weeks
Locations:
city: Yozgat
country: Turkey
facility: Akdağmadeni School of Health
city: Yozgat
country: Turkey
facility: Bozok University
Study officials:
References: