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

Tri-Service General Hospital, Department of Internal Medicine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05174975
Enrollment
100
Registered
2022-01-03
Start date
2021-10-20
Completion date
2023-10-31
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, self-care behaviors, quality of lofe

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).

Detailed 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.

Interventions

BEHAVIORALApp-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.

Sponsors

Kaohsiung Medical University
CollaboratorOTHER
Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Quality of lifeAt baseline and 1 week, 3 months and 9 months after the interventiontA 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.
Change in Self-care behaviourAt baseline and 1 week, 3 months and 9 months after the interventionA 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.
Change in Glycosylated hemoglobin(HbA1c) levelsAt baseline and 1 week, 3 months and 9 months after the interventionCollect from medical records

Secondary

MeasureTime frameDescription
Change in Diabetes Self-efficacyAt baseline and 1 week, 3 months and 9 months after the interventiontA 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.
Change in Diabetes DistressAt baseline and 1 week, 3 months and 9 months after the interventionA 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.
Change in Diabetic Positive CharacteristicsAt baseline and 1 week, 3 months and 9 months after the interventionA 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.
Change in OptimismAt baseline and 1 week, 3 months and 9 months after the interventionA 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.
Change in GratitudeAt baseline and 1 week, 3 months and 9 months after the interventionA 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026