Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes

NCT05174975 | Completed

• 1 other identifier: B202105141
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this experimental study is to explore the effectiveness of app-based positive psychology intervention (PPI) on patients newly diagnosed with type 2 diabetes (T2DM).

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus; self-care behaviors; quality of lofe

Outcome Measures

Primary Outcomes (3)

• Change in Quality of life

  A 15-item Quality of Life Scale will be used to measure quality of life. Each item is rated from 0 (Never) to 4(Always), with higher scores indicating a higher quality of life.

  At baseline and 1 week, 3 months and 9 months after the interventiont

• Change in Self-care behaviour

  A 17-item Diabetes Self-care Behaviour Scale-Chinese version will be used to measure. Each item is rates from 0 (never) to 4 (always). The higher score indicates a greater execution in self-care behaviours.

  At baseline and 1 week, 3 months and 9 months after the intervention

• Change in Glycosylated hemoglobin(HbA1c) levels

  Collect from medical records

  At baseline and 1 week, 3 months and 9 months after the intervention

Secondary Outcomes (5)

• Change in Diabetes Distress

  At baseline and 1 week, 3 months and 9 months after the intervention

• Change in Optimism

  At baseline and 1 week, 3 months and 9 months after the intervention

• Change in Gratitude

  At baseline and 1 week, 3 months and 9 months after the intervention

• Change in Diabetes Self-efficacy

  At baseline and 1 week, 3 months and 9 months after the interventiont

• Change in Diabetic Positive Characteristics

  At baseline and 1 week, 3 months and 9 months after the intervention

Study Arms (2)

App-based Positive Psychological Intervention group

EXPERIMENTAL

The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation.

Behavioral: App-based Positive Psychological Intervention

control group

NO INTERVENTION

usual care which will educated by certificated educators in terms of self-management

Interventions

App-based Positive Psychological Intervention BEHAVIORAL

The PPI has included a 12-week PPI lessons. Each lesson has separated into 3 parts: introduction, activity, and feedback. Diabetes-related health education will include the basic knowledge of diabetes, diet, and exercise related videos. Physical records include record of daily blood sugar, blood pressure, HbA1c, diet, and exercise. In terms of dietary records, the amount of carbohydrates of each food will be calculate automatically after documented. Exercise records documents the burn of calories of each exercise (per 30 minutes). Both unit of dietary and exercise are based on Health Promotion Administration's criteria in Taiwan. Moreover, participants are available to have one-on-one instant online consultation with their diabetes educators via App.

App-based Positive Psychological Intervention group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• newly diagnosed with T2DM less than 6 months
• aged 20 to 64
• controlling diabetes through oral medication or insulin injection
• able to use Android phone

You may not qualify if:

• unable to communicate with language or having mental illness

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• Kaohsiung Medical University: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Publications (14)

• Celano CM, Beale EE, Moore SV, Wexler DJ, Huffman JC. Positive psychological characteristics in diabetes: a review. Curr Diab Rep. 2013 Dec;13(6):917-29. doi: 10.1007/s11892-013-0430-8.

  PMID: 24048687 BACKGROUND

• Celano CM, Gianangelo TA, Millstein RA, Chung WJ, Wexler DJ, Park ER, Huffman JC. A positive psychology-motivational interviewing intervention for patients with type 2 diabetes: Proof-of-concept trial. Int J Psychiatry Med. 2019 Mar;54(2):97-114. doi: 10.1177/0091217418791448. Epub 2018 Aug 16.

  PMID: 30114958 BACKGROUND

• Cohn MA, Pietrucha ME, Saslow LR, Hult JR, Moskowitz JT. An online positive affect skills intervention reduces depression in adults with type 2 diabetes. J Posit Psychol. 2014 Jan 1;9(6):523-534. doi: 10.1080/17439760.2014.920410.

  PMID: 25214877 BACKGROUND

• Dubois CM, Beach SR, Kashdan TB, Nyer MB, Park ER, Celano CM, Huffman JC. Positive psychological attributes and cardiac outcomes: associations, mechanisms, and interventions. Psychosomatics. 2012 Jul-Aug;53(4):303-18. doi: 10.1016/j.psym.2012.04.004.

  PMID: 22748749 BACKGROUND

• Hsu HC, Lee YJ, Wang RH. Influencing Pathways to Quality of Life and HbA1c in Patients With Diabetes: A Longitudinal Study That Inform Evidence-Based Practice. Worldviews Evid Based Nurs. 2018 Apr;15(2):104-112. doi: 10.1111/wvn.12275. Epub 2018 Feb 14.

  PMID: 29443437 BACKGROUND

• Hsu HC, Chang YH, Lee PJ, Chen SY, Hsieh CH, Lee YJ, Wang RH. Developing and psychometric testing of a short-form problem areas in diabetes scale in chinese patients. J Nurs Res. 2013 Sep;21(3):212-8. doi: 10.1097/01.jnr.0000432048.31921.e2.

  PMID: 23958611 BACKGROUND

• Huffman JC, DuBois CM, Millstein RA, Celano CM, Wexler D. Positive Psychological Interventions for Patients with Type 2 Diabetes: Rationale, Theoretical Model, and Intervention Development. J Diabetes Res. 2015;2015:428349. doi: 10.1155/2015/428349. Epub 2015 Apr 29.

  PMID: 26064980 BACKGROUND

• Huffman JC, Feig EH, Millstein RA, Freedman M, Healy BC, Chung WJ, Amonoo HL, Malloy L, Slawsby E, Januzzi JL, Celano CM. Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome. Am J Cardiol. 2019 Jun 15;123(12):1906-1914. doi: 10.1016/j.amjcard.2019.03.023. Epub 2019 Mar 19.

  PMID: 30979409 BACKGROUND

• Lee YJ, Shin SJ, Wang RH, Lin KD, Lee YL, Wang YH. Pathways of empowerment perceptions, health literacy, self-efficacy, and self-care behaviors to glycemic control in patients with type 2 diabetes mellitus. Patient Educ Couns. 2016 Feb;99(2):287-94. doi: 10.1016/j.pec.2015.08.021. Epub 2015 Sep 2.

  PMID: 26341940 BACKGROUND

• Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.

  PMID: 11811629 BACKGROUND

• Miller CK, Kristeller JL, Headings A, Nagaraja H. Comparison of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a randomized controlled trial. Health Educ Behav. 2014 Apr;41(2):145-54. doi: 10.1177/1090198113493092. Epub 2013 Jul 12.

  PMID: 23855018 BACKGROUND

• Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. J Consult Clin Psychol. 2017 May;85(5):409-423. doi: 10.1037/ccp0000188. Epub 2017 Mar 23.

  PMID: 28333512 BACKGROUND

• Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.

  PMID: 7815302 BACKGROUND

• Steinhardt MA, Brown SA, Dubois SK, Harrison L Jr, Lehrer HM, Jaggars SS. A resilience intervention in African-American adults with type 2 diabetes. Am J Health Behav. 2015 Jul;39(4):507-18. doi: 10.5993/AJHB.39.4.7.

  PMID: 26018099 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chieh-Hua Lu

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: Participants are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 3, 2022
• Study Start: October 20, 2021
• Primary Completion: July 30, 2023
• Study Completion: October 31, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)