Type2 DiabetesNCT03553680
An Emotion-Focused Intervention for Glycemic Control in T2D
A study testing Emotion-Focused CBT in people with Type2 Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
The primary aim of this proposed project is to collect pilot data using an Emotion-Focused CBT Psycho-social Intervention i individuals with T2D to obtain the effect sizes on hypothesized changes in Negative Emotionality, Diabetes Distress, and HbA1c values that will be needed for a more appropriately sized clinical… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Emotion-Focused CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 19 Oct 2018
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving care for T2D at Kovler Diabetes Center, at UCM, or in the community.
- Documented diagnosis of T2D for at least one year.
- Age: 21-65 years of age.
- HbA1c > 7.0 (with hemoglobin in the normal range).
- ER-Exp Screen score of > 29 and/or ER-Skill Screen score < 44.
- Stable medical co-morbid conditions.
- Able to read English.
- Able to give informed consent.
Who cannot join
- Documented diagnosis of T2D less than one year.
- Age: < 21 or > 65 years of age.
- HbA1c < 7.0 .
- ER-Exp screen score of < 29 and ER-Skill score =/> 44.
- Unstable medical co-morbid conditions.
- Active psychosis or suicidal/homicidal ideation.
- Not able to read English.
- Not able to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study
The primary aim of this proposed project is to collect pilot data using an Emotion-Focused CBT Psycho-social Intervention i individuals with T2D to obtain the effect sizes on hypothesized changes in Negative Emotionality, Diabetes Distress, and HbA1c values that will be needed for a more appropriately sized clinical trial for an RO1 submission to the National Institutes of Health.
Read the detailed description
Our interest in aberrant Emotional Regulation / Emotional Intelligence in Type 2 Diabetes stems from observations that while many patients with Type 2 Diabetes have greater incidence of mood and anxiety (and even anger) disorders than controls, targeting psychiatric conditions, such as depression, is not sufficient to improve glycemic control in patients with diabetes. Thus, the key issue for such patients is not what specific psychiatric disorder they have, but the presence of an impairment in the fundamental regulation of emotional regulation and in how such individuals modulate their emotional response to aversive events in their lives (e.g., emotional intelligence), now suggested by a recent study. As part of a new study, we examined the relationship between glycemic control (HbA1c) and Emotional Experience (ER-Exp) and Skill at Emotional Regulation (ER-Skill) in 100 adult patients with Type 2 Diabetes. We found significant relationships between ER-Exp and ER-Skill and HbA1c levels that accounted for nearly 24% of the variance in HbA1c levels. These relationships with HbA1c levels remained even after accounting for other relevant behavioral variables such as depression/anxiety scores and diabetes self-care/literacy scores. Accordingly, the tendency of an individual to have intense emotional responses (higher scores on ER-Exp), and/or to have a reduced ability to understand/modulate one's emotions in order to cope with daily stresses/threats (lower scores on ER-Skill), may well be linked with poor glycemic control (HbA1c) in adult patients with Type 2 Diabetes. If so, it will be important to develop psycho-social methods to improve ER-Exp and DR-Skill in Type 2 Diabetes patients to determine if one can improve aberrant Emotional Regulation (ER-Exp/ER-Skill), Diabetes Distress (DD), and HbA1c (A1c) levels as suggested by treatment studies showing that such treatment can improve ER-Skill with a sustained reduction in A1c levels in Type 2 Diabetes for up to nine months. Supporting these findings are data from a recent study showing that increasing positive emotion reduces (and increasing negative emotion increases) blood glucose levels, especially in those with poor emotion regulation skills.
Specific Study Objectives:
- Develop an integrated Emotion - Focused Psycho-social EF-CBT) from three (3) existing sources that contain elements to improve ER-Exp and ER-Skill.
- Conduct a pilot study in 10 patients with Type 2 Diabetes with aberrant ER-ER-Exp/ER-Skill and compare treatment outcomes in emotionality, diabetes distress, and in A1c levels with 10 patients with Type 2 Diabetes undergoing treatment as usual (TAU).
- Conditions
- Type2 Diabetes
- Being tested
- Emotion-Focused CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused CBTBehavioural
10 CBT Sessions to improve emotional regulation and emotional intelligence.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-Focused CBT | Experimental | Ten CBT sessions with a therapist. Receives: Behavioral: Emotion-Focused CBT |
| Wait List | No intervention | Three visits for assessments only over the same time period of the Experimental Arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ER-Exp Score
ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality
Measured: Baseline, mid-point, and end-point (about 10-12 weeks).
Change Score in ER-Skill Score
Skill at emotional regulation (Clarity and Repair). Lower scores indicate reduced skill at modulating negative emotions
Measured: Baseline, ,mid-point and end-point (about 10-12 weeks)
Change in HbA1c level
HbA1c levels
Measured: Baseline, mid-point, and end-point (about 10-12 weeks)
Change in Diabetes Distress
Distress at living with and coping with diabetes
Measured: Baseline, mid-point, and end-point (about 10-12 weeks)
Secondary outcomes (1)
Change in Diabetes Self-Care
Self-Care Inventory-Revised: higher scores mean great efforts at self-care.
Measured: Baseline, mid-point, and end-point (about 10-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start20 Oct 2017
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Emotion-Focused CBT
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emil F Coccaro, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553680
- Sponsor's protocol ID
- 17-0635
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Emotion-Focused Psychosocial Intervention for Improved Glycemic Control in T2D Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03553680
- Acronym / sponsor ID
- 17-0635
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 12 Jun 2018 (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.
The primary aim of this proposed project is to collect pilot data using an Emotion-Focused CBT Psycho-social Intervention i individuals with T2D to obtain the effect sizes on hypothesized changes in Negative Emotionality, Diabetes Distress, and HbA1c values that will be needed for a more appropriately sized clinical trial for an RO1 submission to the National Institutes of Health.
Detailed description
Our interest in aberrant Emotional Regulation / Emotional Intelligence in Type 2 Diabetes stems from observations that while many patients with Type 2 Diabetes have greater incidence of mood and anxiety (and even anger) disorders than controls, targeting psychiatric conditions, such as depression, is not sufficient to improve glycemic control in patients with diabetes. Thus, the key issue for such patients is not what specific psychiatric disorder they have, but the presence of an impairment in the fundamental regulation of emotional regulation and in how such individuals modulate their emotional response to aversive events in their lives (e.g., emotional intelligence), now suggested by a recent study. As part of a new study, we examined the relationship between glycemic control (HbA1c) and Emotional Experience (ER-Exp) and Skill at Emotional Regulation (ER-Skill) in 100 adult patients with Type 2 Diabetes. We found significant relationships between ER-Exp and ER-Skill and HbA1c levels that accounted for nearly 24% of the variance in HbA1c levels. These relationships with HbA1c levels remained even after accounting for other relevant behavioral variables such as depression/anxiety scores and diabetes self-care/literacy scores. Accordingly, the tendency of an individual to have intense emotional responses (higher scores on ER-Exp), and/or to have a reduced ability to understand/modulate one's emotions in order to cope with daily stresses/threats (lower scores on ER-Skill), may well be linked with poor glycemic control (HbA1c) in adult patients with Type 2 Diabetes. If so, it will be important to develop psycho-social methods to improve ER-Exp and DR-Skill in Type 2 Diabetes patients to determine if one can improve aberrant Emotional Regulation (ER-Exp/ER-Skill), Diabetes Distress (DD), and HbA1c (A1c) levels as suggested by treatment studies showing that such treatment can improve ER-Skill with a sustained reduction in A1c levels in Type 2 Diabetes for up to nine months. Supporting these findings are data from a recent study showing that increasing positive emotion reduces (and increasing negative emotion increases) blood glucose levels, especially in those with poor emotion regulation skills.
Specific Study Objectives:
- Develop an integrated Emotion - Focused Psycho-social EF-CBT) from three (3) existing sources that contain elements to improve ER-Exp and ER-Skill.
- Conduct a pilot study in 10 patients with Type 2 Diabetes with aberrant ER-ER-Exp/ER-Skill and compare treatment outcomes in emotionality, diabetes distress, and in A1c levels with 10 patients with Type 2 Diabetes undergoing treatment as usual (TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Emotion-Focused CBT
| Arm | Type | Receives |
|---|---|---|
| Emotion-Focused CBT | Experimental | Behavioral: Emotion-Focused CBTTen CBT sessions with a therapist. |
| Wait List | No intervention | –Three visits for assessments only over the same time period of the Experimental Arm. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Receiving care for T2D at Kovler Diabetes Center, at UCM, or in the community.
- Documented diagnosis of T2D for at least one year.
- Age: 21-65 years of age.
- HbA1c > 7.0 (with hemoglobin in the normal range).
- ER-Exp Screen score of > 29 and/or ER-Skill Screen score < 44.
Key exclusion criteria (8 listed)
- Documented diagnosis of T2D less than one year.
- Age: < 21 or > 65 years of age.
- HbA1c < 7.0 .
- ER-Exp screen score of < 29 and ER-Skill score =/> 44.
- Unstable medical co-morbid conditions.
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 |
|---|---|---|
| Emotion-Focused CBT10 CBT Sessions to improve emotional regulation and emotional intelligence. | Behavioural | Emotion-Focused CBT |
Primary outcome
Change in the ER-Exp Score
Time frame: Baseline, mid-point, and end-point (about 10-12 weeks).
ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality
Change Score in ER-Skill Score
Time frame: Baseline, ,mid-point and end-point (about 10-12 weeks)
Skill at emotional regulation (Clarity and Repair). Lower scores indicate reduced skill at modulating negative emotions
Change in HbA1c level
Time frame: Baseline, mid-point, and end-point (about 10-12 weeks)
HbA1c levels
Change in Diabetes Distress
Time frame: Baseline, mid-point, and end-point (about 10-12 weeks)
Distress at living with and coping with diabetes
1 secondary outcome
Change in Diabetes Self-Care
Time frame: Baseline, mid-point, and end-point (about 10-12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Emil F Coccaro, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused CBT in people with Type2 Diabetes, run by University of Chicago 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 8 inclusion and 8 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 22 Apr 2020. 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?
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?
Change in the ER-Exp Score (time frame: Baseline, mid-point, and end-point (about 10-12 weeks).). The study lists 4 primary outcomes in all. 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 22 Apr 2020.