Stress Management Among Latinos With Type 2 Diabetes (CALMS-D)

Yale University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: stress management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01578096

R01MD005879 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Diabetes education

No Intervention group

Description:

Group-based diabetes education delivered to participants through community health workers

Diabetes education plus stress management

Experimental group

Description:

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

Treatment:

Behavioral: stress management