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Completed

NCT Number: NCT04611737

Self-Determination Theory and Motivational Interviewing

Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

About this study

Participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. The intervention is based on integrated self-determination theory and motivational interviewing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with schizophrenia and Type 2 Diabetes
  • between 20 years old to 80 years old
  • can communicate in Chinese langue

Exclusion criteria

  • can not communicate well
  • have neurocognitive disorders

Treatment and study plan

Interviewing

Behavioral

Self-Determination Theory within motivational interviewing

Primary outcomes

  1. HbA1C

    Time frame: on interviewing day1, and 3 months

    Blood sugar level during the 3 months

  2. Body weight

    Time frame: on interviewing day1, and 3 months

    weight (in kilograms)

  3. height

    Time frame: on interviewing day1, and 3 months

    height (in meters), eight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Brief Psychiatric Rating Scale

    Time frame: on interviewing day1, and 3 months

    The Brief Psychiatric Rating Scale with 18 items is use to measure psychiatric symptoms. Each symptom is rated 1-7 with higher scores indicating severer symptoms.

  2. Treatment Self-Regulation Questionnaire-Diabetes

    Time frame: on interviewing day1, and 3 months

    The treatment Self-Regulation Questionnaire-Diabetes a 19-item scale used to examine the self-regulation behaviors for diabetes of participants. Each item is ranged from 1 to 7 and higher scores showing more motivations in self-regulation diabetes.

  3. Perceived Diabetes Self-Management Scale

    Time frame: on interviewing day1, and 3 months

    The Perceived Diabetes Self-Management Scale is an 8-item scale with 4 of the items (1, 2, 6, & 7) being reverse-scored. Each item is ranged from 1 to 5 and higher scores showing more confidence in self-managing diabetes.

  4. Depression Anxiety Stress Scales

    Time frame: on interviewing day1, and 3 months

    The Depression Anxiety Stress Scales is a self-report scale with 21 items designed to assess depression, stress and anxiety of participants. Scores for each symptom is ranged from 0 to 3 with higher scores indicating severer symptoms.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Developing and Testing of Integrating Self-Determination Theory and Motivational Interviewing Based Diabetic Self-management Program Among Schizophrenic Patients With Diabetes

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2020
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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