Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Syracuse University

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus; Depression; Stress

Treatments: Behavioral: Expressive writing; Behavioral: Neutral writing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00233142

R01AT002477 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 187 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 2 patient groups

Expressive writing

Experimental group

Description:

Expressive writing

Treatment:

Behavioral: Expressive writing

Neutral writing

Sham Comparator group

Description:

Non-expressive writing

Treatment:

Behavioral: Neutral writing