Expressive Writing for Reducing Stress and Diabetic Symptoms in Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-02-28

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.

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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.

Conditions

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Diabetes Mellitus Stress Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Expressive writing

Group Type EXPERIMENTAL

Expressive writing

Intervention Type BEHAVIORAL

Writing as therapeutic intervention

Neutral writing

Non-expressive writing

Group Type SHAM_COMPARATOR

Neutral writing

Intervention Type BEHAVIORAL

Non-expressive writing

Interventions

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Expressive writing

Writing as therapeutic intervention

Intervention Type BEHAVIORAL

Neutral writing

Non-expressive writing

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No