Clinical trial NCT06912737: Group Emotion-Focused Behavioral Intervention for Diabetes Distress/A1c in T2D.
Official title: Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: T2DM (Type 2 Diabetes Mellitus)
Keywords: T2D
Diabetes Distress
HbA1c
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the study participants will be randomized to G-EFBI and half to G-WEHL.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diabetes Distress Scale (DDS)
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: HbA1c Level
timeFrame: Week 0, Week 5, Week 10 and Month 6
Secondary outcomes:
measure: Emotion Regulation Skill (ER-Skill)
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Emotion Regulation Experience (ER-Exp)
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Self-Care Inventory-Revised (SCI-R)
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Patient Activation Measure (PAM) for Engagement/Motivation
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: PHQ-9 for State Depression
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: GAD-7 for State Anxiety
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Perceived Stress Scale (PSS) for Perceived Psychosocial Stress
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Quality of Life Experience and Satisfaction (Q-LES-Q)
timeFrame: Week 0, Week 5, Week 10 and Month 6
measure: Assessment of Acceptance, Appropriateness, and Feasibility of Intervention.
timeFrame: Week 10 and Month 6
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: