Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.

April 2, 2025 updated by: Emil Coccaro, Ohio State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female adults with documented diagnosis of T2D for at least one year.
  2. Age > 18 years of age.
  3. Diabetes Distress Scale score > 2.0 on any DDS subscale.
  4. A1c > 7.5 (with hemoglobin in the normal range).
  5. PHQ-9 Depression score < 15.
  6. Stable medical co-morbid conditions.
  7. Absence of a psychotic disorder or an intellectual disability.
  8. Able to read English.
  9. Able to give informed consent.

Exclusion Criteria:

  1. Male and female adults with documented diagnosis of T2D for less than one year.
  2. Age < 18 years of age.
  3. Diabetes Distress Scale score < 2.0 on all DDS subscales.
  4. A1c < 7.5 (with hemoglobin in the normal range).
  5. PHQ-9 Depression score > 15.
  6. Unstable medical co-morbid conditions (e.g., hospitalization in past three months).
  7. Presence of a psychotic disorder or an intellectual disability.
  8. Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.
  9. Unable to read English.
  10. Unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: Group - With Every Heartbeat is Life (G-WEHL)
G-WEHL is an educational intervention designed to increase awareness and prevention of cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 0, Week 5, Week 10 and Month 6
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%.
Week 0, Week 5, Week 10 and Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion Regulation Skill (ER-Skill)
Time Frame: Week 0, Week 5, Week 10 and Month 6
The "Clarity of Emotion" and "Repair of Emotion" scores from the Trait Meta-Mood (TMM) scale will constitute ER-Skill score.
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
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.
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
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.
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
The Patient Activation Measure (PAM), assessing skill/confidence for self-management will be used to assess engagement/motivation.
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
State Depression will be assessed by commonly used PHQ-9 which is a nine-item screening assessment of current symptoms of depression.
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
State Anxiety will be assessed by GAD-7, a commonly used 7-item screening measure of state anxiety.
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
Perceived psychosocial stress will be assessed by the Perceived Stress Scale (Past Month). This is a ten item scale.
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
Q=LES-Q is a 16-item QOL scale that assesses quality of life experience and satisfaction across several domains.
Week 0, Week 5, Week 10 and Month 6
Assessment of Acceptance, Appropriateness, and Feasibility of Intervention.
Time Frame: Week 10 and Month 6
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).
Week 10 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024H0014
  • R01DK135948 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

January 1, 2030

IPD Sharing Access Criteria

Any relevant health sciences investigator currently appointed at an academic institution.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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