Stress Management Among Latinos With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— CALMS-D  

Official title:

Stress Management Among Latinos With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578096
• Other study ID #: R01MD005879
• Secondary ID: R01MD005879
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aims of this study are to:

1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.

2. Investigate the efficacy of the stress management intervention on glycemic control.

Secondary aims of this study are to:

3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.

Study hypothesis:

A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Latinos age 18 or older that are ambulatory

• Spanish speaking

• Diagnosed with type 2 diabetes for at least 1 year

• Hemoglobin A1c levels greater than 7.0

Exclusion Criteria:

• Medical instability or medical treatment requiring inpatient care

• Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder

• Current suicidality or history of suicide attempt

• History of psychiatric hospitalization

• Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• stress management
The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Hartford Hospital, Hispanic Health Council, Inc., National Institute on Minority Health and Health Disparities (NIMHD), UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Blood will be drawn from participants and hemoglobin A1c levels will be measured	Baseline
Primary	Hemoglobin A1c	Blood will be drawn from participants and hemoglobin A1c levels will be measured	9 weeks
Primary	Hemoglobin A1c	Blood will be drawn from participants and hemoglobin A1c levels will be measured	6 months
Secondary	Diabetes specific distress	Participants will be asked questions assessing their perspective of emotional distress from living with diabetes	Baseline
Secondary	Diabetes specific distress	Participants will be asked questions assessing their perspective of emotional distress from living with diabetes	9 weeks
Secondary	Diabetes specific distress	Participants will be asked questions assessing their perspective of emotional distress from living with diabetes	6 months