Type 2 DiabetesNCT06398093
Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
A study testing Self-Compassion Tool Kit in people with Type 2 Diabetes and Diabetes Distress, run by University of California, San Diego at 1 site in United States.
Trial summary
There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Diabetes Distress
- What is being tested?
- Self-Compassion Tool Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has type 2 diabetes
- Has a score above 2 on the T2D Distress Assessment Scale
Who cannot join
- Does not have type 2 diabetes
- Has a score above 2 on the T2D Distress Assessment Scale
- Cannot safely exercise
- Cannot complete the requested tasks
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92037
Amalia Axinn, BA, aaxinn@health.ucsd.edu
Edward Chao, DO, 619-400-5050 ext. Chao, ecchao@health.ucsd.edu
About this study
There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.
Read the detailed description
A pre-test and post-test experimental design will be used to evaluate the efficacy of the self-compassion tool kit on distress, coping, testing glucose, sleep, and wellness in adults living with T2D.
For this 4-week study, participants will receive education on Sleep Hygiene practices during the first week of the intervention. Mindfulness meditation will be offered to participants using the Headspace app and four, ten-minute sessions will be prescribed per week. For exercise, 30-60 minutes of daily physical activity will be prescribed and participants can select the exercise of their choice. Additionally, participants will receive a journal in the mail with prompts associated with each day of required journalling. Prompts will elicit reflections, gratitude and growth. Participants will be followed by telephone every week. Baseline and week four data will be collected using the Demographic Form, T2DDAS, the Pittsburgh Sleep Quality Index (PSQI) and the SF-20. In addition, participants will be instructed to maintain a glucose testing, meditation, and exercise adherence log. The glucose testing log will permit measuring consistency and adherence to treatment over the course of the study.
- Conditions
- Type 2 Diabetes, Diabetes Distress
- Being tested
- Self-Compassion Tool Kit
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion Tool KitBehavioural
Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion Toolkit | Experimental | Not described Receives: Behavioral: Self-Compassion Tool Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Compassion
Will assess for change pre and post-intervention on standardized questionnaires on diabetes distress and self-compassion scores after the intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 Jul 2024
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Chao, University of California, San Diego
- Investigators
- Edward C Chao, DO, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398093
- Sponsor's protocol ID
- 810394
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Considering sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06398093
- Acronym / sponsor ID
- 810394
- Conditions
- Type 2 Diabetes, Diabetes Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.
Detailed description
A pre-test and post-test experimental design will be used to evaluate the efficacy of the self-compassion tool kit on distress, coping, testing glucose, sleep, and wellness in adults living with T2D.
For this 4-week study, participants will receive education on Sleep Hygiene practices during the first week of the intervention. Mindfulness meditation will be offered to participants using the Headspace app and four, ten-minute sessions will be prescribed per week. For exercise, 30-60 minutes of daily physical activity will be prescribed and participants can select the exercise of their choice. Additionally, participants will receive a journal in the mail with prompts associated with each day of required journalling. Prompts will elicit reflections, gratitude and growth. Participants will be followed by telephone every week. Baseline and week four data will be collected using the Demographic Form, T2DDAS, the Pittsburgh Sleep Quality Index (PSQI) and the SF-20. In addition, participants will be instructed to maintain a glucose testing, meditation, and exercise adherence log. The glucose testing log will permit measuring consistency and adherence to treatment over the course of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Toolkit | Experimental | Behavioral: Self-Compassion Tool Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has type 2 diabetes
- Has a score above 2 on the T2D Distress Assessment Scale
Key exclusion criteria (4 listed)
- Does not have type 2 diabetes
- Has a score above 2 on the T2D Distress Assessment Scale
- Cannot safely exercise
- Cannot complete the requested tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Compassion Tool KitParticipants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks. | Behavioural | Self-Compassion Toolkit |
Primary outcome
Self-Compassion
Time frame: 4 weeks
Will assess for change pre and post-intervention on standardized questionnaires on diabetes distress and self-compassion scores after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes. Considering sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward C Chao, DO principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion Tool Kit in people with Type 2 Diabetes and Diabetes Distress, run by University of California, San Diego at 1 site in United States.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amalia Axinn, BS (6194005050, aaxinn@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.