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Type 1 DiabetesNCT05070949

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

A study testing Mindful Self-Compassion in people with Type 1 Diabetes, run by Mahidol University at 2 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study explored the effects of self-compassion intervention on diabetes distress and self-compassion. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Mindful Self-Compassion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesThailand
Study dates
1 Jan 2022to 7 Nov 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 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Faculty of Medicine Ramathibodi Hospital

    Bangkok, Ratchatewi, 10400

  • Faculty of Medicine Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

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

Read the 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).

Conditions
Type 1 Diabetes
Being tested
Mindful Self-Compassion
Keywords
self-compassion, diabetes distress, sleep
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful Self-CompassionBehavioural

    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

Study groups in NCT05070949
Study groupRoleWhat they receive
Mindful Self-CompassionExperimentalParticipants 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
Receives: Behavioral: Mindful Self-Compassion
Wait List ControlNo interventionWait 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline to 24 weeks

  2. 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.

    Measured: baseline to 24 weeks

Secondary outcomes (4)

  1. 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).

    Measured: baseline to 24 weeks

  2. Hemoglobin A1C

    HbA1c will be obtained by blood test.

    Measured: baseline and 12 weeks

  3. 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).

    Measured: baseline to 24 weeks

  4. 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.

    Measured: baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2021
  2. Study start1 Jan 2022
  3. Primary completion10 Oct 2023
  4. Study completion7 Nov 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05070949
Sponsor's protocol ID
2933
Status last verified
May 2025
First submitted
15 May 2021
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22228744

  • 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.

    PubMed 23033244

  • 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.

    PubMed 20150291

  • 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.

    PubMed 27118163

  • 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.

    PubMed 23711019

  • 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.

    PubMed 27335319

  • 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.

    PubMed 23070875

  • 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.

    PubMed 32235629

  • 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.

    PubMed 18570645

  • 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.

    PubMed 24772581

  • 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.

    PubMed 20540784

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Self-Compassion in people with Type 1 Diabetes, run by Mahidol University at 2 sites in Thailand.

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 3 inclusion and 7 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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?

Diabetes distress (time frame: baseline to 24 weeks). The study lists 2 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 NCT05070949, which also lists 11 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 13 May 2025.

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