Stress Management Among Latinos With Type 2 Diabetes

Study Overview
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Brief Summary
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The primary aims of this study are to: Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population. Investigate the efficacy of the stress management intervention on glycemic control. Secondary aims of this study are to: 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.

Official Title
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Stress Management Among Latinos With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: stress management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Diabetes education<br>Group-based diabetes education delivered to participants through community health workers | |
| Experimental: Diabetes education plus stress management<br>Group-based diabetes education plus stress management delivered to participants through community health workers | Behavioral: stress management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Blood will be drawn from participants and hemoglobin A1c levels will be measured | Baseline | 
| Hemoglobin A1c | Blood will be drawn from participants and hemoglobin A1c levels will be measured | 9 weeks | 
| Hemoglobin A1c | Blood will be drawn from participants and hemoglobin A1c levels will be measured | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes specific distress | Participants will be asked questions assessing their perspective of emotional distress from living with diabetes | Baseline | 
| Diabetes specific distress | Participants will be asked questions assessing their perspective of emotional distress from living with diabetes | 9 weeks | 
| Diabetes specific distress | Participants will be asked questions assessing their perspective of emotional distress from living with diabetes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes