Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05070949
• Other study ID #: 2933
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.

Description:

This study tests the effects of a 12-week mindful self-compassion (MSC) program in people with type 1 diabetes. Eighty participants will be randomized to the MSC program or be in a wait-list control group. Measures of primary outcome are self-compassion and diabetes- distress. Secondary outcomes are hemoglobin A1C, diabetes self-efficacy, stress and depression symptoms, and sleep quality. Outcomes will be measured at baseline, 12 weeks (end of the program) and 24 weeks (post program).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes, age 18-30

• own computer or tablet with access to internet for meetings

• willingness to complete all 6 sessions

Exclusion criteria:

• history of self-harm or suicide attempt in the pat one year

• severe diabetic complications such as dialysis or blindness

• unstable depression, requiring ongoing medication adjustment within the last 3 months

• A1C > 11%

• Severe hypoglycemia requiring emergency room visit or hospitalization in the past 6 months

• History of Diabetic Ketoacidosis requiring hospitalization in the past 3 months

• pregnant or intend to get pregnant during the study timeframe

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Mindful Self-Compassion
Bi-weekly meeting will involve six lessons: What is Self-Compassion , Practicing Self-Compassion, Discovering your Compassionate Voice, Self-Compassion and Resilience , Self-Compassion and Burnout and Making it Count

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Chulalongkorn University	Bangkok
Thailand	Faculty of Medicine Ramathibodi Hospital	Bangkok	Ratchatewi

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

Aikens JE. Prospective associations between emotional distress and poor outcomes in type 2 diabetes. Diabetes Care. 2012 Dec;35(12):2472-8. doi: 10.2337/dc12-0181. Epub 2012 Oct 1. — View Citation

Fisher L, Glasgow RE, Strycker LA. The relationship between diabetes distress and clinical depression with glycemic control among patients with type 2 diabetes. Diabetes Care. 2010 May;33(5):1034-6. doi: 10.2337/dc09-2175. Epub 2010 Feb 11. — View Citation

Fisher L, Hessler D, Polonsky W, Strycker L, Masharani U, Peters A. Diabetes distress in adults with type 1 diabetes: Prevalence, incidence and change over time. J Diabetes Complications. 2016 Aug;30(6):1123-8. doi: 10.1016/j.jdiacomp.2016.03.032. Epub 2016 Apr 4. — View Citation

Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6. — View Citation

Friis AM, Johnson MH, Cutfield RG, Consedine NS. Kindness Matters: A Randomized Controlled Trial of a Mindful Self-Compassion Intervention Improves Depression, Distress, and HbA1c Among Patients With Diabetes. Diabetes Care. 2016 Nov;39(11):1963-1971. Epub 2016 Jun 22. — View Citation

Lotrakul M, Sumrithe S, Saipanish R. Reliability and validity of the Thai version of the PHQ-9. BMC Psychiatry. 2008 Jun 20;8:46. doi: 10.1186/1471-244X-8-46. — View Citation

Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15. — View Citation

Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013 Jul;30(7):767-77. doi: 10.1111/dme.12245. Erratum in: Diabet Med. 2013 Oct;30(10):1266. — View Citation

Sitasuwan T, Bussaratid S, Ruttanaumpawan P, Chotinaiwattarakul W. Reliability and validity of the Thai version of the Pittsburgh Sleep Quality Index. J Med Assoc Thai. 2014 Mar;97 Suppl 3:S57-67. — View Citation

Tunsuchart K, Lerttrakarnnon P, Srithanaviboonchai K, Likhitsathian S, Skulphan S. Type 2 Diabetes Mellitus Related Distress in Thailand. Int J Environ Res Public Health. 2020 Mar 30;17(7). pii: E2329. doi: 10.3390/ijerph17072329. — View Citation

Wongpakaran N, Wongpakaran T. The Thai version of the PSS-10: An Investigation of its psychometric properties. Biopsychosoc Med. 2010 Jun 12;4:6. doi: 10.1186/1751-0759-4-6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes distress	Diabetes distress will be evaluated by a questionnaire. Each item is rated on a 6-point Likert scale from 1 (no problem) to 6 (serious problems).; Scores range from 17 to 102, which the higher scores indicate the higher diabetes distress levels (A worse outcome).	baseline to 24 weeks
Primary	Self-compassion	Self-compassion will be evaluated by a questionnaire. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).; Scores range from 26 to 130, which the higher scores indicate the higher self-compassion levels (A better outcome). This outcome is reported in the mean difference of self-compassion score between two groups.	baseline to 24 weeks
Secondary	Diabetes Self-efficacy	Diabetes self-efficacy will be measured by questionnaire. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).; Scores range from 19 to 95, which the higher scores indicate the higher self-efficacy levels (A better outcome).	baseline to 24 weeks
Secondary	Hemoglobin A1C	HbA1c will be obtained by blood test.	baseline and 12 weeks
Secondary	Sleep quality	Sleep quality will be measured by a questionnaire. Each item is rated on a 4-point Likert scale from 0 (very good) to 3 (very bad).; Scores range from 0 to 21, which the higher scores indicate poor sleep quality (A worse outcome).	baseline to 24 weeks
Secondary	Stress and depressive symptoms	stress and depressive symptoms will be measured by a questionnaire. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). Scores range from 0 to 40, which the higher scores indicate higher stress and depression (A worse outcome). This outcome is reported in the mean difference of stress and depression score between two groups.	baseline to 24 weeks