Diabetes Mellitus, Type 2NCT05174975
Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes
A study testing App-based Positive Psychological Intervention in people with Diabetes Mellitus, Type 2, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- App-based Positive Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- unable to communicate with language or having mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tri-Service General Hospital, Department of Internal Medicine
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- App-based Positive Psychological Intervention
- Keywords
- diabetes mellitus, self-care behaviors, quality of lofe
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Positive Psychological InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-based Positive Psychological Intervention |
| control group | No intervention | usual care which will educated by certificated educators in terms of self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
Change in Glycosylated hemoglobin(HbA1c) levels
Collect from medical records
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
Secondary outcomes (5)
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.
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
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.
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
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.
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
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.
Measured: At baseline and 1 week, 3 months and 9 months after the interventiont
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.
Measured: At baseline and 1 week, 3 months and 9 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Oct 2021
- Primary completion30 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Principal investigator, Chieh-Hua Lu, Tri-Service General Hospital (TSGH)
- Investigators
- Chieh-Hua Lu, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174975
- Sponsor's protocol ID
- B202105141
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2021
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: depend on the finding and process of publication
Publications
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.
PubMed 24048687Celano 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.
PubMed 30114958Cohn 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.
PubMed 25214877Dubois 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.
PubMed 22748749Hsu 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.
PubMed 29443437Hsu 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.
PubMed 23958611Huffman 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.
PubMed 26064980Huffman 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.
PubMed 30979409Lee 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.
PubMed 26341940Mccullough 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.
PubMed 11811629Miller 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.
PubMed 23855018Moskowitz 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.
PubMed 28333512Scheier 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.
PubMed 7815302Steinhardt 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.
PubMed 26018099
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-Service General Hospital, Department of Internal Medicine
- ClinicalTrials.gov ID
- NCT05174975
- Acronym / sponsor ID
- B202105141
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, self-care behaviors, quality of lofe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| App-based Positive Psychological Intervention group | Experimental | Behavioral: App-based Positive Psychological InterventionThe intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation. |
| control group | No intervention | –usual care which will educated by certificated educators in terms of self-management |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unable to communicate with language or having mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Positive Psychological InterventionThe 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. | Behavioural | App-based Positive Psychological Intervention group |
Primary outcome
Change in Quality of life
Time frame: At baseline and 1 week, 3 months and 9 months after the interventiont
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.
Change in Self-care behaviour
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
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.
Change in Glycosylated hemoglobin(HbA1c) levels
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
Collect from medical records
5 secondary outcomes
Change in Diabetes Distress
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
Change in Optimism
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
Change in Gratitude
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
Change in Diabetes Self-efficacy
Time frame: At baseline and 1 week, 3 months and 9 months after the interventiont
Change in Diabetic Positive Characteristics
Time frame: At baseline and 1 week, 3 months and 9 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 24048687Celano 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.
- Background: PubMed 30114958Celano 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.
- Background: PubMed 25214877Cohn 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.
- Background: PubMed 22748749Dubois 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.
- Background: PubMed 29443437Hsu 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.
- Background: PubMed 23958611Hsu 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.
- Background: PubMed 26064980Huffman 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.
- Background: PubMed 30979409Huffman 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.
- Background: PubMed 26341940Lee 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.
- Background: PubMed 11811629Mccullough 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.
- Background: PubMed 23855018Miller 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.
- Background: PubMed 28333512Moskowitz 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.
- Individual participant dataSharing planned: No. depend on the finding and process of publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chieh-Hua Lu principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based Positive Psychological Intervention in people with Diabetes Mellitus, Type 2, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (time frame: At baseline and 1 week, 3 months and 9 months after the interventiont). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174975, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.