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

NCT ID: NCT05070949

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-11-07

Brief Summary

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

Detailed Description

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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).

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mindful Self-Compassion

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

Group Type EXPERIMENTAL

Mindful Self-Compassion

Intervention Type BEHAVIORAL

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

Wait List Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Ratanaporn Jerawatana

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Ramathibodi Hospital

Bangkok, Ratchatewi, Thailand

Site Status

Faculty of Medicine Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 22228744 (View on PubMed)

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.

Reference Type RESULT
PMID: 23033244 (View on PubMed)

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.

Reference Type RESULT
PMID: 20150291 (View on PubMed)

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.

Reference Type RESULT
PMID: 27118163 (View on PubMed)

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.

Reference Type RESULT
PMID: 23711019 (View on PubMed)

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.

Reference Type RESULT
PMID: 27335319 (View on PubMed)

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.

Reference Type RESULT
PMID: 23070875 (View on PubMed)

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.

Reference Type RESULT
PMID: 32235629 (View on PubMed)

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.

Reference Type RESULT
PMID: 18570645 (View on PubMed)

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.

Reference Type RESULT
PMID: 24772581 (View on PubMed)

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.

Reference Type RESULT
PMID: 20540784 (View on PubMed)

Other Identifiers

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2933

Identifier Type: -

Identifier Source: org_study_id

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