An Emotion-Focused Intervention for Glycemic Control in T2D

NCT03553680 | Completed

• 1 other identifier: 17-0635
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 trial for an RO1 submission to the National Institutes of Health.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (4)

• Change in the ER-Exp Score

  ER-Exp: Intensity and lability of negative emotion, higher scores indicate greater native emotionality

  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

  Baseline, ,mid-point and end-point (about 10-12 weeks)

• Change in HbA1c level

  HbA1c levels

  Baseline, mid-point, and end-point (about 10-12 weeks)

• Change in Diabetes Distress

  Distress at living with and coping with diabetes

  Baseline, mid-point, and end-point (about 10-12 weeks)

Secondary Outcomes (1)

• Change in Diabetes Self-Care

  Baseline, mid-point, and end-point (about 10-12 weeks)

Study Arms (2)

Emotion-Focused CBT

EXPERIMENTAL

Ten CBT sessions with a therapist.

Behavioral: Emotion-Focused CBT

Wait List

NO INTERVENTION

Three visits for assessments only over the same time period of the Experimental Arm.

Interventions

Emotion-Focused CBT BEHAVIORAL

10 CBT Sessions to improve emotional regulation and emotional intelligence.

Emotion-Focused CBT

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

• Emil F Coccaro, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Emotion-Focused CBT

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 12, 2018
• Study Start: October 20, 2017
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: April 22, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)