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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Tri-Service General Hospital, Department of Internal Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174975
• Other study ID #: B202105141
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Positive psychological constructs (PPCs), such as optimism, gratitude, self-efficacy, and resilience have been considered to positively impact adherence and self-care behaviour of patients with type 2 diabetes (T2DM). Moreover, diabetes self-care behaviours would be consistently improved as the PPCs have strengthened. Based on systematic reviews, the positive psychological intervention has significantly improved positive emotions, quality of life, self-efficacy, depression, optimism, gratitude, and well-being of patients with T2DM The strengthen of PPCs could be regarded as a strategy for improving type 2 diabetes self-management.

Positive psychology intervention (PPI) emphasis enhancing PPCs via consciousness raising and enhancing personal strengths. With the systemic practice of PPI, it develops individual positive cognition and emotions. A previous Internet-based intervention study found that people have been taught positive emotional skills shown a significantly lower depression level than those having the daily emotional diary. Additionally, a one-group pre-post test study found that both optimism and gratitude have significantly increased after a 12-week phone-based PPI in patients with T2DM. Another one-group pretest-posttest study demonstrated that optimism and well-being had significantly increased after a 12-week PPI. Furthermore, optimism, gratitude, frustrated, depressive, and distress, diabetes self-care and health behaviours adherence have obvious improved. A recent study demonstrated that self-care behaviour and diet behaviour had significantly improved after a 16-week phone-based psychological-motivational interviewing intervention among the patients with Type 2 diabetes (T2DM) with 8 years duration of diabetes. Although previous studies have demonstrated the effectiveness of PPI on PPCs, only few studies investigate the impact on patients newly diagnosed with T2DM. Thus, the aim of this study is to explore the effectiveness of app-based PPI on patients newly diagnosed with T2DM.

Patients newly diagnosed with T2DM of an endocrinology clinic in a medical center in northern Taiwan are assigned to the experimental group (n=57), while patients at an endocrinology clinic in southern Taiwan are assigned to the control group (n=113). Experimental group will have a 3-month App-based intervention, while the control group only have a diabetes-related health education by certificated diabetes educators. Outcome variables will be collected from medical records and self-reported questionnaires. A Generalized Estimation Equation (GEE) is used to compare the changing amount of outcome variables from baseline to week at the end of intervention, to 3 months, and to 9 months post-intervention between a control group and experimental group. A p-value <.05 is considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• unable to communicate with language or having mental illness

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• App-based Positive Psychological Intervention
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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Tri-Service General Hospital	Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Glycosylated hemoglobin(HbA1c) levels	Collect from medical records	At baseline and 1 week, 3 months and 9 months after the intervention
Secondary	Change in Diabetes Distress	A 8-item short form of Problem Areas in Diabetes scale in Chinese version will be used to measure. Each items is rated from 0 (not a problem) to 4 (very serious problem). The higher score indicates a greater level of diabetes distress.	At baseline and 1 week, 3 months and 9 months after the intervention
Secondary	Change in Optimism	A 6-item Life Orientation Test-Revised will be used to measure. Each item is rated from 0 as strongly disagree to 4 as strongly agree. The higher scores indicates higher dispositional level of optimism.	At baseline and 1 week, 3 months and 9 months after the intervention
Secondary	Change in Gratitude	A 6-item Gratitude Questionnaire will be used to measure. Each item is rated from 1 (strongly disagree) to 7 (strongly agree). The higher score indicates higher gratitude disposition.	At baseline and 1 week, 3 months and 9 months after the intervention
Secondary	Change in Diabetes Self-efficacy	A 14-item Diabetes Self-efficacy scale will be used to measure. Each item is rated from 0 as "Extremely unconfident" to 4 as "80% to 100% confident". The higher score indicates the better self-efficacy.	At baseline and 1 week, 3 months and 9 months after the interventiont
Secondary	Change in Diabetic Positive Characteristics	A 20-item Diabetic Positive Characteristic Scale will be used to measure. Each item is rated from 1 as "strongly disagree" to 5 as "strongly agree". The overall score is 100 points, with higher scores indicating greater likelihood of positive characteristics disposition.	At baseline and 1 week, 3 months and 9 months after the intervention