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

T

Tri-Service General Hospital

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: App-based Positive Psychological Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05174975
B202105141

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

App-based Positive Psychological Intervention group
Experimental group
Description:
The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation.
Treatment:
Behavioral: App-based Positive Psychological Intervention
control group
No Intervention group
Description:
usual care which will educated by certificated educators in terms of self-management

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ruey-Hsia Wang; Shi-Yu CHEN

Data sourced from clinicaltrials.gov

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