NCT00233142

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for phase_2 diabetes-mellitus

Timeline
Completed

Started Sep 2005

Typical duration for phase_2 diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 15, 2016

Status Verified

November 1, 2009

Enrollment Period

3.4 years

First QC Date

September 13, 2005

Last Update Submit

April 13, 2016

Conditions

Diabetes MellitusStressDepression

Keywords

DiabetesEmotionsBlood glucoseExpressive Writing

Outcome Measures

Primary Outcomes (1)

  • hemoglobin A1C (indicator of blood glucose)

    baseline, 4 months, 8 months, 12 months, and 16 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Expressive writing

EXPERIMENTAL

Expressive writing

Behavioral: Expressive writing

Neutral writing

SHAM COMPARATOR

Non-expressive writing

Behavioral: Neutral writing

Interventions

Expressive writingBEHAVIORAL

Writing as therapeutic intervention

Expressive writing
Neutral writingBEHAVIORAL

Non-expressive writing

Neutral writing

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of diabetes mellitus made after age 24

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

State University of New York Medical University

Syracuse, New York, 13244, United States

Location

Syracuse University

Syracuse, New York, 13244, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDepression

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Joshua M. Smyth, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 5, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 15, 2016

Record last verified: 2009-11

Locations

US(4)