NCT05070949

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

May 15, 2021

Last Update Submit

May 8, 2025

Conditions

Type 1 Diabetes

Keywords

self-compassiondiabetes distresssleep

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Diabetes Self-efficacy

    baseline to 24 weeks

  • Hemoglobin A1C

    baseline and 12 weeks

  • Sleep quality

    baseline to 24 weeks

  • Stress and depressive symptoms

    baseline to 24 weeks

Study Arms (2)

Mindful Self-Compassion

EXPERIMENTAL

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

Behavioral: Mindful Self-Compassion

Wait List Control

NO INTERVENTION

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.

Interventions

Mindful Self-CompassionBEHAVIORAL

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

Mindful Self-Compassion

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes, age 18-30
  • own computer or tablet with access to internet for meetings
  • willingness to complete all 6 sessions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine Ramathibodi Hospital

Bangkok, Ratchatewi, 10400, Thailand

Location

Faculty of Medicine Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (11)

  • 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.

    PMID: 22228744RESULT

  • 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.

    PMID: 23033244RESULT

  • 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.

    PMID: 20150291RESULT

  • 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.

    PMID: 27118163RESULT

  • 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.

    PMID: 23711019RESULT

  • 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.

    PMID: 27335319RESULT

  • 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.

    PMID: 23070875RESULT

  • 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.

    PMID: 32235629RESULT

  • 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.

    PMID: 18570645RESULT

  • 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.

    PMID: 24772581RESULT

  • 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.

    PMID: 20540784RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2021

First Posted

October 7, 2021

Study Start

January 1, 2022

Primary Completion

October 10, 2023

Study Completion

November 7, 2023

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)