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

Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 16 visits
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study will have 16 visits."
  • "ER-Experience from the Affect Lability Scales (ALS); ER-Skill from the Trait-Meta-Mood (TMM) questionnaire. 4."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

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