Stress Management Among Latinos With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: stress management

• Registration Number: NCT01578096
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-16
• Study Start: 2012-05
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes education plus stress management	stress management	Group-based diabetes education plus stress management delivered to participants through community health workers

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 months	Blood will be drawn from participants and hemoglobin A1c levels will be measured

Secondary Outcome Measures

Name	Time	Method
Diabetes specific distress	6 months	Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States