T2DM (Type 2 Diabetes Mellitus)NCT06912737
Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
A study testing Group Emotion Focused Behavioral Intervention (G-EFBI) and Group - With Every Heartbeat is Life (G-WEHL) in people with T2DM (Type 2 Diabetes Mellitus), run by Ohio State University at 1 site in United States.
Trial summary
T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c < 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Group Emotion Focused Behavioral Intervention (G-EFBI) and Group - With Every Heartbeat is Life (G-WEHL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male and female adults with documented diagnosis of T2D for at least one year.
- Age > 18 years of age.
- Diabetes Distress Scale score > 2.0 on any DDS subscale.
- A1c > 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score < 15.
- Stable medical co-morbid conditions.
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- Absence of a psychotic disorder or an intellectual disability.
- Able to read English.
- Able to give informed consent.
Who cannot join
- Male and female adults with documented diagnosis of T2D for less than one year.
- Age < 18 years of age.
- Diabetes Distress Scale score < 2.0 on all DDS subscales.
- A1c < 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score > 15.
- Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
Show all 10Show fewer
- Presence of a psychotic disorder or an intellectual disability.
- Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
- Unable to read English.
- Unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.
T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c < 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. While a range of factors have been identified in this regard, we posit that a barrier to treatment are broad difficulty with emotional regulation that are not diagnosis-specific but lead to Diabetes Distress (DD) and difficulty in coping with medical regimens, and other aspects of diabetes self-care, in the context of the psychosocial stressors associated with T2D. Extant data suggests that sub-optimal emotional regulation (experience of intense emotion and skill at regulating emotion) is related to elevated DD and A1c levels, and that an Emotion-Focused Behavioral Intervention (EFBI) can reduce both DD and A1c levels in PWD with T2D. In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and preliminary efficacy data to determine if G-EFBI is a feasible, acceptable and, possibly, efficacious intervention compared to an "Attentional Control" intervention in PWD with T2D and elevated DD and A1c levels.
Read the detailed description
This is an early-stage treatment development project proposing to conduct a modest randomized clinical trial of Group EFBI, vs. a Group Attentional Control Intervention, to collect feasibility, acceptability, and preliminary efficacy data in study participants with poorly controlled T2D (A1c > 7.5) and high Diabetes Distress Scale (DDS) scores (= or > 2 on any DDS subscale). This study will seek to study up to one hundred and twenty (120) study participants with T2D and elevated A1c and DDS scores will be recruited for about twelve (12) groups of seven to ten (7-10) to obtain feasibility, acceptability, and preliminary efficacy data. Participants will be randomized to ten 75-minute sessions of G-EFBI or of the Attentional Control Group Intervention, "With Every Heartbeat Is Life" (WEHL). WEHL is a psychoeducational intervention designed to increase awareness and prevention of cardiovascular disease and contains no ER related content. Study groups of patients with T2D will be recruited as above. This study will have 16 visits. Visit #1. Informed Consent and final assessment for study entry. Study participants must have a current A1c > 7.5%, a current DDS score > 2.0 on any DDS subscale, and be medically stable (e.g., without chronic renal failure). Assessments are listed below: 1. Glycemic Control. A1c using a DCA Vantage (Siemens) "point of contact" (POC) instrument. Blood (< 1 cc) is taken from a fingerstick. The total number of finger sticks in this study is four for a total blood collection volume of < 5 cc. 2. Diabetes Related Distress. Diabetes Distress Scale (DDS) 3. ER-Experience and ER-Skill. ER-Experience from the Affect Lability Scales (ALS); ER-Skill from the Trait-Meta-Mood (TMM) questionnaire. 4. Diabetes Self-Care and Engagement/Motivation. The Self-Care Inventory-Revised (SCI-R) and the Patient Activation Measure (PAM). 5. Depression, Anxiety, Stress, and Quality of Life (Q-LES-Q). State Depression/State Anxiety be assessed by PHQ-9 and GAD-7; Psychosocial stress assessed by the Perceived Stress Scale (PSS); Q-LES-Q will be assessed by Quality-of-Life Experience and Satisfaction. Visit #2: This is a 30-60 minute preparation session prior to the participant starting group intervention. Visit #3-7: Start G-EFBI or G-WEHL Sessions 1-5. Visit #8 (Mid-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / QOL. Visits 10-14: G-EFBI or G-WEHL Sessions 6-10. Visit #15 (End-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / Q-LES-Q. Visits #16 Post-Rx Assessment at Six Month F/U). Same as Visit #15.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- Group Emotion Focused Behavioral Intervention (G-EFBI), Group - With Every Heartbeat is Life (G-WEHL)
- Keywords
- T2D, Diabetes Distress, HbA1c
- 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.
Group Emotion Focused Behavioral Intervention (G-EFBI)Behavioural
Group EFBI (G-EFBI) is aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions.
Group - With Every Heartbeat is Life (G-WEHL)Behavioural
G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| Group Emotion Focused Behavioral Intervention (G-EFBI) | Experimental | Group EFBI (G-EFBI) is a 10-session, 75-minute, program aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions. G-EFBI begins with discussions regarding the relationship between events, feelings, and behaviors/actions and how this relates to diabetes management. The intervention moves to teaching participants: (1) how to identify emotions and understand their purpose; (2) learn how identifying the physiological/behavioral pattern of their own emotions; (3) learn the importance of recognizing emotions in themselves and in others; (4) learn strategies aimed at helping them to better cope and manage their emotions; (5) learn to use specific emotional restructuring strategies (i.e., reframing, finding the evidence) to change their negative emotional responses to daily stressors and events as it relates to diabetes management. Receives: Behavioral: Group Emotion Focused Behavioral Intervention (G-EFBI) |
| G-WEHL | Active comparator | To control for the effect of attention given to participants in G-EFBI that can result in psychosocial improvements, participants will be randomized to either G-EFBI or Group-With Every Heartbeat is Life (G-WEHL). G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease. This intervention has ten 75-minute content sessions covering cardiovascular risk reduction in terms of diet, physical activity, and smoking cessation; the G-WEHL manual is provided in the Clinical Trials Section of this application; G-WEHL has no elements relevant to emotion regulation. The use of WEHL in this study is relevant because cardiovascular disease affects one-third of PWD, is a major cause of mortality (~ 50%), and impact (20-49%) on direct medical costs of T2D. Receives: Behavioral: Group - With Every Heartbeat is Life (G-WEHL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress Scale (DDS)
The Diabetes Distress Scale (DDS) will be used to assess psychological distress associated with the care and management of T2D; assessment of DD is critical for T2D intervention studies. The 17-item DDS has four subscales: regimen-related distress, emotional burden, physician distress, and interpersonal distress. Respondents have six options for each item ranging from "1" (not a problem) to "6" (a very serious problem). Mean Scores > 2.0 are at threshold for clinically meaningful DD.
Measured: Week 0, Week 5, Week 10 and Month 6
HbA1c Level
A1c is measured at Visit #1 (Pre-Intervention) Visit #8 (Mid-Point), Visit #14 (After End of Intervention) and at Visit #15 (Six Month Follow-Up). A DCA Vantage (Siemens) "point of contact" (POC) instrument will be used for A1c levels. The research assistant will be trained in obtaining the fingerstick sample by the PI/Co-I (Drs. Coccaro and Joseph) and in how to operate the instrument. Our POC method displays a "unity" correlation with commercial assays (Roche Labs): r =.993 (p < .001) and bias of 0.03%.
Measured: Week 0, Week 5, Week 10 and Month 6
Secondary outcomes (9)
Emotion Regulation Skill (ER-Skill)
The "Clarity of Emotion" and "Repair of Emotion" scores from the Trait Meta-Mood (TMM) scale will constitute ER-Skill score.
Measured: Week 0, Week 5, Week 10 and Month 6
Emotion Regulation Experience (ER-Exp)
The "Negative Emotional Intensity" score from the Affect Intensity Measure (AIM) and "Anxiety/Depression Lability" score from the Affect Lability Scales (ALS) will constitute the ER-Exp score.
Measured: Week 0, Week 5, Week 10 and Month 6
Self-Care Inventory-Revised (SCI-R)
The Self-Care Inventory-Revised (SCI-R), included in our previous studies, will be used to assesses how well patients have followed self-care recommendations in the past month.
Measured: Week 0, Week 5, Week 10 and Month 6
Patient Activation Measure (PAM) for Engagement/Motivation
The Patient Activation Measure (PAM), assessing skill/confidence for self-management will be used to assess engagement/motivation.
Measured: Week 0, Week 5, Week 10 and Month 6
PHQ-9 for State Depression
State Depression will be assessed by commonly used PHQ-9 which is a nine-item screening assessment of current symptoms of depression.
Measured: Week 0, Week 5, Week 10 and Month 6
GAD-7 for State Anxiety
State Anxiety will be assessed by GAD-7, a commonly used 7-item screening measure of state anxiety.
Measured: Week 0, Week 5, Week 10 and Month 6
Perceived Stress Scale (PSS) for Perceived Psychosocial Stress
Perceived psychosocial stress will be assessed by the Perceived Stress Scale (Past Month). This is a ten item scale.
Measured: Week 0, Week 5, Week 10 and Month 6
Quality of Life Experience and Satisfaction (Q-LES-Q)
Q=LES-Q is a 16-item QOL scale that assesses quality of life experience and satisfaction across several domains.
Measured: Week 0, Week 5, Week 10 and Month 6
Assessment of Acceptance, Appropriateness, and Feasibility of Intervention.
Acceptability, Appropriateness, and Feasibility of Intervention (AAFI), as developed by Weiner et al. will be done at post-intervention (end of trial and six month follow-up). The AAFI comprises of three (3) four item Likert scale (1-5: strongly disagree to strongly agree) questionnaires with good internal (α's: 0.85 to 0.91) and test-retest (r=0.73 to 0.88), reliability known-groups validity, and sensitivity to change in both directions. These are Acceptability of Intervention Measure AIM), Intervention Appropriate Measure (IAM), and Feasibility of Intervention Measure (FIM).
Measured: Week 10 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Half of the study participants will be randomized to G-EFBI and half to G-WEHL.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Coccaro, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912737
- Sponsor's protocol ID
- 2024H0014
- Other IDs
- R01DK135948
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, clinical, and clinical trial data will be acquired from up to 120 individuals with Type 2 Diabetes. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier will be collected for each subject.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.
- ClinicalTrials.gov ID
- NCT06912737
- Acronym / sponsor ID
- 2024H0014
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Keywords
- T2D, Diabetes Distress, HbA1c
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Apr 2025 (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.
T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c < 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. While a range of factors have been identified in this regard, we posit that a barrier to treatment are broad difficulty with emotional regulation that are not diagnosis-specific but lead to Diabetes Distress (DD) and difficulty in coping with medical regimens, and other aspects of diabetes self-care, in the context of the psychosocial stressors associated with T2D. Extant data suggests that sub-optimal emotional regulation (experience of intense emotion and skill at regulating emotion) is related to elevated DD and A1c levels, and that an Emotion-Focused Behavioral Intervention (EFBI) can reduce both DD and A1c levels in PWD with T2D. In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and preliminary efficacy data to determine if G-EFBI is a feasible, acceptable and, possibly, efficacious intervention compared to an "Attentional Control" intervention in PWD with T2D and elevated DD and A1c levels.
Detailed description
This is an early-stage treatment development project proposing to conduct a modest randomized clinical trial of Group EFBI, vs. a Group Attentional Control Intervention, to collect feasibility, acceptability, and preliminary efficacy data in study participants with poorly controlled T2D (A1c > 7.5) and high Diabetes Distress Scale (DDS) scores (= or > 2 on any DDS subscale). This study will seek to study up to one hundred and twenty (120) study participants with T2D and elevated A1c and DDS scores will be recruited for about twelve (12) groups of seven to ten (7-10) to obtain feasibility, acceptability, and preliminary efficacy data. Participants will be randomized to ten 75-minute sessions of G-EFBI or of the Attentional Control Group Intervention, "With Every Heartbeat Is Life" (WEHL). WEHL is a psychoeducational intervention designed to increase awareness and prevention of cardiovascular disease and contains no ER related content. Study groups of patients with T2D will be recruited as above. This study will have 16 visits. Visit #1. Informed Consent and final assessment for study entry. Study participants must have a current A1c > 7.5%, a current DDS score > 2.0 on any DDS subscale, and be medically stable (e.g., without chronic renal failure). Assessments are listed below: 1. Glycemic Control. A1c using a DCA Vantage (Siemens) "point of contact" (POC) instrument. Blood (< 1 cc) is taken from a fingerstick. The total number of finger sticks in this study is four for a total blood collection volume of < 5 cc. 2. Diabetes Related Distress. Diabetes Distress Scale (DDS) 3. ER-Experience and ER-Skill. ER-Experience from the Affect Lability Scales (ALS); ER-Skill from the Trait-Meta-Mood (TMM) questionnaire. 4. Diabetes Self-Care and Engagement/Motivation. The Self-Care Inventory-Revised (SCI-R) and the Patient Activation Measure (PAM). 5. Depression, Anxiety, Stress, and Quality of Life (Q-LES-Q). State Depression/State Anxiety be assessed by PHQ-9 and GAD-7; Psychosocial stress assessed by the Perceived Stress Scale (PSS); Q-LES-Q will be assessed by Quality-of-Life Experience and Satisfaction. Visit #2: This is a 30-60 minute preparation session prior to the participant starting group intervention. Visit #3-7: Start G-EFBI or G-WEHL Sessions 1-5. Visit #8 (Mid-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / QOL. Visits 10-14: G-EFBI or G-WEHL Sessions 6-10. Visit #15 (End-Point Assessment): A1c / DDS / AIM / ALS / TMM / SCI-R / PHQ-9 / GAD-7 / PSS / Q-LES-Q. Visits #16 Post-Rx Assessment at Six Month F/U). Same as Visit #15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the study participants will be randomized to G-EFBI and half to G-WEHL.
| Arm | Type | Receives |
|---|---|---|
| Group Emotion Focused Behavioral Intervention (G-EFBI) | Experimental | Behavioral: Group Emotion Focused Behavioral Intervention (G-EFBI)Group EFBI (G-EFBI) is a 10-session, 75-minute, program aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions. G-EFBI begins with discussions regarding the relationship between events, feelings, and behaviors/actions and how this relates to diabetes management. The intervention moves to teaching participants: (1) how to identify emotions and understand their purpose; (2) learn how identifying the physiological/behavioral pattern of their own emotions; (3) learn the importance of recognizing emotions in themselves and in others; (4) learn strategies aimed at helping them to better cope and manage their emotions; (5) learn to use specific emotional restructuring strategies (i.e., reframing, finding the evidence) to change their negative emotional responses to daily stressors and events as it relates to diabetes management. |
| G-WEHL | Active comparator | Behavioral: Group - With Every Heartbeat is Life (G-WEHL)To control for the effect of attention given to participants in G-EFBI that can result in psychosocial improvements, participants will be randomized to either G-EFBI or Group-With Every Heartbeat is Life (G-WEHL). G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease. This intervention has ten 75-minute content sessions covering cardiovascular risk reduction in terms of diet, physical activity, and smoking cessation; the G-WEHL manual is provided in the Clinical Trials Section of this application; G-WEHL has no elements relevant to emotion regulation. The use of WEHL in this study is relevant because cardiovascular disease affects one-third of PWD, is a major cause of mortality (~ 50%), and impact (20-49%) on direct medical costs of T2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female adults with documented diagnosis of T2D for at least one year.
- Age > 18 years of age.
- Diabetes Distress Scale score > 2.0 on any DDS subscale.
- A1c > 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score < 15.
Key exclusion criteria (10 listed)
- Male and female adults with documented diagnosis of T2D for less than one year.
- Age < 18 years of age.
- Diabetes Distress Scale score < 2.0 on all DDS subscales.
- A1c < 7.5 (with hemoglobin in the normal range).
- PHQ-9 Depression score > 15.
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 |
|---|---|---|
| Group Emotion Focused Behavioral Intervention (G-EFBI)Group EFBI (G-EFBI) is aimed at assisting people with T2D to gain knowledge about emotions and improve their ability to regulate and manage their emotions. | Behavioural | Group Emotion Focused Behavioral Intervention (G-EFBI) |
| Group - With Every Heartbeat is Life (G-WEHL)G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease. | Behavioural | G-WEHL |
Primary outcome
Diabetes Distress Scale (DDS)
Time frame: Week 0, Week 5, Week 10 and Month 6
The Diabetes Distress Scale (DDS) will be used to assess psychological distress associated with the care and management of T2D; assessment of DD is critical for T2D intervention studies. The 17-item DDS has four subscales: regimen-related distress, emotional burden, physician distress, and interpersonal distress. Respondents have six options for each item ranging from "1" (not a problem) to "6" (a very serious problem). Mean Scores > 2.0 are at threshold for clinically meaningful DD.
HbA1c Level
Time frame: Week 0, Week 5, Week 10 and Month 6
A1c is measured at Visit #1 (Pre-Intervention) Visit #8 (Mid-Point), Visit #14 (After End of Intervention) and at Visit #15 (Six Month Follow-Up). A DCA Vantage (Siemens) "point of contact" (POC) instrument will be used for A1c levels. The research assistant will be trained in obtaining the fingerstick sample by the PI/Co-I (Drs. Coccaro and Joseph) and in how to operate the instrument. Our POC method displays a "unity" correlation with commercial assays (Roche Labs): r =.993 (p < .001) and bias of 0.03%.
9 secondary outcomes
Emotion Regulation Skill (ER-Skill)
Time frame: Week 0, Week 5, Week 10 and Month 6
Emotion Regulation Experience (ER-Exp)
Time frame: Week 0, Week 5, Week 10 and Month 6
Self-Care Inventory-Revised (SCI-R)
Time frame: Week 0, Week 5, Week 10 and Month 6
Patient Activation Measure (PAM) for Engagement/Motivation
Time frame: Week 0, Week 5, Week 10 and Month 6
PHQ-9 for State Depression
Time frame: Week 0, Week 5, Week 10 and Month 6
GAD-7 for State Anxiety
Time frame: Week 0, Week 5, Week 10 and Month 6
Perceived Stress Scale (PSS) for Perceived Psychosocial Stress
Time frame: Week 0, Week 5, Week 10 and Month 6
Quality of Life Experience and Satisfaction (Q-LES-Q)
Time frame: Week 0, Week 5, Week 10 and Month 6
Assessment of Acceptance, Appropriateness, and Feasibility of Intervention.
Time frame: Week 10 and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Yes. Demographic, clinical, and clinical trial data will be acquired from up to 120 individuals with Type 2 Diabetes. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier will be collected for each subject.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Emotion Focused Behavioral Intervention (G-EFBI) and Group - With Every Heartbeat is Life (G-WEHL) in people with T2DM (Type 2 Diabetes Mellitus), run by Ohio State University 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julian Roberts, R.N. (614-257-2086, julian.roberts@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Scale (DDS) (time frame: Week 0, Week 5, Week 10 and Month 6). 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?
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 6 Apr 2025.