Motivational Interviewing Applied to Individuals With Diabetes

April 2, 2024 updated by: Betül Bal, Bozok University

The Effect of Motivational Interviewing on Well-being, Stress and Difficulties in Individuals With Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Yozgat, Turkey
        • Recruiting
        • Akdağmadeni School of Health
        • Contact:
      • Yozgat, Turkey
        • Recruiting
        • Bozok University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational Interviewing
Motivational interviewing will be conducted in four sessions and the session duration will be maximum 40 minutes. The session will be conducted individually and online once a week. For the individual interview, the appropriate day and time will be determined with the individuals with diabetes and the researcher before the first session and the sessions will continue on the same day and time every week. The researcher will remind the participant about the time of the session by calling the participant by phone one day before each session. Motivational interview sessions will be held online on the Whatsapp platform.
Behavioral: motivational interview
Motivational interviewing will be conducted in four sessions and the session duration will be maximum 40 minutes. The session will be conducted individually and online once a week. For the individual interview, the appropriate day and time will be determined with the individuals with diabetes and the researcher before the first session and the sessions will continue on the same day and time every week. The researcher will remind the participant about the time of the session by calling the participant by phone one day before each session. Motivational interview sessions will be held online on the Whatsapp platform.
No Intervention: Control
The patients in the control group, on the other hand, did not undergo any intervention other than their routine treatment and care. The patients were followed for four weeks. Before the study, data collection tools were applied to the patients. Again, after the study started and the study ended, all other data collection tools were applied, except the "Patient Information Form".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coping with stress
Time Frame: 4 weeks
This scale will be administered twice before and after the intervention to determine the patients' coping methods with stress. The scale consists of three sub-dimensions: problem-focused coping (8 items), social support-focused coping (7 items) and avoidance-focused coping (8 items). The scale consists of a total of 23 items, 20 of which are positively worded and three items (items 10, 17, 20) are negatively worded. A score of 23-115 can be obtained from the whole scale. The higher the score obtained from the whole scale and subscales reflects the tendency of the person to use the relevant ways of coping with stress.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State of Well-Being Change
Time Frame: 4 weeks
The scale consists of 5 items containing 5 positive statements about the participant's emotions in the last 2 weeks. Each item is evaluated on a 6-point Likert-type scale ranging from 0-5; a score of 0 indicates no positive emotions in the last 2 weeks, while a score of 5 indicates continuous positive emotions. Raw scores are converted into a scoring scale between 0-10. A score below 50 indicates low mood.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing Strength and Difficulties in Diabetes
Time Frame: 4 weeks
As a result of the factor analysis, the scale of strengths and difficulties in type 2 diabetes consisted of 3 sub-dimensions and 30 items in total. Each item in the scale is in 5-point Likert type and the minimum score that can be obtained from the scale is 30 and the maximum score is 150. There are no reverse items in the scale. An increase in the score obtained from the scale indicates that the difficulties experienced by individuals with type 2 diabetes increase.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BozokUni

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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