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

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mindful Self-Compassion
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring self-compassion, diabetes distress, sleep

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Ramathibodi Hospital
  • Faculty of Medicine Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindful Self-Compassion

Wait List Control

Arm Description

Participants will meet every 2 weeks via zoom application or equivalent online meeting platforms, for 12 weeks. The sessions will be led by a clinical psychologist. The curriculum will follow mindful compassion program by Neff KD

Wait list control group will not participate in the MSC program during the first 12 weeks of the protocol but will be given an opportunity to participate after 12 weeks, using the same curriculum.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
Hemoglobin A1C
HbA1c will be obtained by blood test.
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).
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.

Full Information

First Posted
May 15, 2021
Last Updated
October 10, 2021
Sponsor
Mahidol University
Collaborators
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05070949
Brief Title
Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
Official Title
Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study explored the effects of self-compassion intervention on diabetes distress and self-compassion.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
self-compassion, diabetes distress, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Self-Compassion
Arm Type
Experimental
Arm Description
Participants will meet every 2 weeks via zoom application or equivalent online meeting platforms, for 12 weeks. The sessions will be led by a clinical psychologist. The curriculum will follow mindful compassion program by Neff KD
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Wait list control group will not participate in the MSC program during the first 12 weeks of the protocol but will be given an opportunity to participate after 12 weeks, using the same curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Self-Compassion
Intervention Description
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
Primary Outcome Measure Information:
Title
Diabetes distress
Description
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).
Time Frame
baseline to 24 weeks
Title
Self-compassion
Description
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.
Time Frame
baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Diabetes Self-efficacy
Description
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).
Time Frame
baseline to 24 weeks
Title
Hemoglobin A1C
Description
HbA1c will be obtained by blood test.
Time Frame
baseline and 12 weeks
Title
Sleep quality
Description
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).
Time Frame
baseline to 24 weeks
Title
Stress and depressive symptoms
Description
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.
Time Frame
baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
State/Province
Ratchatewi
ZIP/Postal Code
10400
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratanaporn Jerawatana, APN
Phone
66635194653
Email
ratanaporn.jer@gmail.com
First Name & Middle Initial & Last Name & Degree
Sirimon Reutrakul, M.D
First Name & Middle Initial & Last Name & Degree
Chorthip Nartsupha Phattanasri, M.D
First Name & Middle Initial & Last Name & Degree
Sira Korpaisarn, M.D
First Name & Middle Initial & Last Name & Degree
Porntip Tachanivate, Msc
First Name & Middle Initial & Last Name & Degree
Chatvara Areevut, Msc
First Name & Middle Initial & Last Name & Degree
Nampeth Saibuathong, Msc
First Name & Middle Initial & Last Name & Degree
Amornrat Hathaidechadusadee, Msc
First Name & Middle Initial & Last Name & Degree
Jandanee Sakmanarit, Msc
First Name & Middle Initial & Last Name & Degree
Chollada Deeampai, Bs
First Name & Middle Initial & Last Name & Degree
Sunee Saetung, Msc
First Name & Middle Initial & Last Name & Degree
Benjamin Weinstein, PhD
Facility Name
Faculty of Medicine Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taninee Sahakitrungruang, MD
Phone
66816468083
Email
taninee.p@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Nitchakarn Laichuthai, MD
First Name & Middle Initial & Last Name & Degree
Nattakarn Numsriskulrat, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22228744
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.
Results Reference
background
PubMed Identifier
23033244
Citation
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.
Results Reference
background
PubMed Identifier
20150291
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.
Results Reference
background
PubMed Identifier
27118163
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.
Results Reference
background
PubMed Identifier
23711019
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.
Results Reference
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PubMed Identifier
27335319
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. doi: 10.2337/dc16-0416. Epub 2016 Jun 22.
Results Reference
background
PubMed Identifier
23070875
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.
Results Reference
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PubMed Identifier
32235629
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):2329. doi: 10.3390/ijerph17072329.
Results Reference
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PubMed Identifier
18570645
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.
Results Reference
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PubMed Identifier
24772581
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.
Results Reference
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PubMed Identifier
20540784
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.
Results Reference
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Self-compassion to Reduce Diabetes Distress in Persons With Type 1 Diabetes

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