Motivational InterviewingNCT06345196
Motivational Interviewing Applied to Individuals With Diabetes
A study testing motivational interview in people with Motivational Interviewing and Stress, run by Bozok University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, Stress, Well-Being, Psychological
- What is being tested?
- motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Dec 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having a diagnosis of Type 1 Diabetes,
- Having limitations in reading and understanding Turkish.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Akdağmadeni School of Health
Yozgat
Betül Bal, 0 (354) 314 14 15, betul.bal@yobu.edu.tr
- Recruiting
Bozok University
Yozgat
Betül Bal, 0 (354) 314 14 15, betul.bal@yobu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Motivational Interviewing, Stress, Well-Being, Psychological, Diabetes Mellitus, Type2diabetes
- Being tested
- motivational interview
- Medical subject headings
- Psychological Well-Being, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | 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. Receives: Behavioral: motivational interview |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in coping with stress
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.
Measured: 4 weeks
Secondary outcomes (1)
State of Well-Being Change
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational InterviewingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Bal, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345196
- Sponsor's protocol ID
- BozokUni
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Well-being, Stress and Difficulties in Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT06345196
- Acronym / sponsor ID
- BozokUni
- Conditions
- Motivational Interviewing, Stress, Well-Being, Psychological, Diabetes Mellitus, Type2diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 Apr 2024 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: motivational interviewMotivational 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. |
| Control | No intervention | –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". |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Having a diagnosis of Type 1 Diabetes,
- Having limitations in reading and understanding Turkish.
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 |
|---|---|---|
| motivational interviewMotivational 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. | Behavioural | Motivational Interviewing |
Primary outcome
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.
1 secondary outcome
State of Well-Being Change
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Related trials for Motivational Interviewing
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Recruiting
Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment
Substance-Related Disorders, Treatment Adherence
Not yet recruiting
Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)
Opioid Use Disorder
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interview in people with Motivational Interviewing and Stress, run by Bozok University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coping with stress (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.