Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Study Overview
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Brief Summary
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This study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing booster sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

Detailed Description
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Diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the United States. Conditions such as stress and depression have been shown to worsen diabetic symptoms. Data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. This study will determine whether diabetes patients can benefit from expressive writing. This study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms. Participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. Participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. Some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. All participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Official Title
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Expressive Writing: Complementary Treatment for Diabetes

Conditions
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Diabetes Mellitus, Stress, Depression

Intervention / Treatment
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* Behavioral: Expressive writing
* Behavioral: Neutral writing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of diabetes mellitus made after age 24 Exclusion Criteria: Diabetes-related emergency room visit within 3 months prior to study entry Use of psychiatric medication within 3 months prior to study entry Visual or manual limitations that preclude reading and writing Use of insulin within the first year of diabetes diagnosis Pregnancy or plan to become pregnant

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expressive writing<br>Expressive writing | Behavioral: Expressive writing<br>* Writing as therapeutic intervention<br>|
| Sham Comparator: Neutral writing<br>Non-expressive writing | Behavioral: Neutral writing<br>* Non-expressive writing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1C (indicator of blood glucose) |  | baseline, 4 months, 8 months, 12 months, and 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes symptoms |  | baseline, 4 months, 8 months, 12 months, and 16 months | 
| stress levels |  | baseline, 4 months, 8 months, 12 months, and 16 months | 
| depression |  | baseline, 4 months, 8 months, 12 months, and 16 months | 
| cognitive function |  | baseline, 4 months, 8 months, 12 months, and 16 months | 
| quality of life |  | baseline, 4 months, 8 months, 12 months, and 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Emotions, Blood glucose, Expressive Writing