NCT06345196

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

March 28, 2024

Last Update Submit

July 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • State of Well-Being Change

    4 weeks

Other Outcomes (1)

  • Changing Strength and Difficulties in Diabetes

    4 weeks

Study Arms (2)

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.

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".

Interventions

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.

Motivational Interviewing

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akdağmadeni School of Health

Yozgat, Turkey (Türkiye)

RECRUITING

Bozok University

Yozgat, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingDiabetes Mellitus

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

October 15, 2024

Primary Completion

November 15, 2024

Study Completion

December 15, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations