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A Computer-Based Intervention for Medically Unexplained Physical Symptoms

Primary Purpose

Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience Building Exercises
Journaling
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Irritable Bowel, Chronic Fatigue, Medically Unexplained Symptoms, Resilience Building Exercises, Depression, Well-Being

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Qualified patients will be primary care patients who meet the following inclusion and exclusion criteria: Patients between the ages of 18 and 75 seeking medical care for physical symptoms (i.e., persistent fatigue, pain complaints, and gastrointestinal, cardiovascular or musculoskeletal symptoms). No major medical illness to explain symptom(s) is found after detailed physical and laboratory assessment. Patients with common disorders such as hypertension, asthma, diabetes, low back strain, etc., will be included if in the opinion of the physician the presenting physical symptoms are not due to the underlying disorder. In order to enter the study, patients must meet criteria for at least 4 medically unexplained symptoms out of the 42 somatic symptoms listed in the Composite International Diagnostic Interview (CIDI) rated as currently present if males and at least 6 symptoms if females (Escobar's abridged criteria).

Exclusion Criteria:

  • Patients without ready access to a computer and the Internet will be excluded from participating. Also excluded will be individuals with life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, and major psychiatric conditions including psychoses, bipolar disorder, and alcohol or drug abuse. Patients will be required to add no medications to their regimen during the study period (approximately 6 weeks).

Sites / Locations

  • UMDNJ-Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Computer-based exercises to be executed at home.

Computer-based exercises to be executed at home.

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptoms
Positive and Negative Affect Scale
Satisfaction with Life Scale

Secondary Outcome Measures

Patient Health Questionnaire
Health Assessment Questionnaire

Full Information

First Posted
April 27, 2007
Last Updated
February 6, 2015
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00468013
Brief Title
A Computer-Based Intervention for Medically Unexplained Physical Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study 60 people with medically unexplained physical symptoms (MUPS) will receive either a 6-session resilience skill building intervention provided fully online or a weekly computerized journaling assignment. Both programs can be completed from home. Participants will complete questionnaires both before and after the intervention and changes in symptoms, mood and satisfaction with life will be assessed.
Detailed Description
SUBJECTS: Sixty patients between the ages of 18 and 80 will be recruited from primary care clinics affiliated with the University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School (UMDNJ-RWJMS). Qualified patients will be primary care patients who meet the following inclusion and exclusion criteria: Patients between the ages of 18 and 75 seeking medical care for physical symptoms (i.e., persistent fatigue, pain complaints, and gastrointestinal, cardiovascular or musculoskeletal symptoms). No major medical illness to explain symptom(s) is found after detailed physical and laboratory assessment. Patients with common disorders such as hypertension, asthma, diabetes, low back strain, etc., will be included if in the opinion of the physician the presenting physical symptoms are not due to the underlying disorder. In order to enter the study, patients must meet criteria for at least 4 medically unexplained symptoms out of the 42 somatic symptoms listed in the Composite International Diagnostic Interview (CIDI) rated as currently present if males and at least 6 symptoms if females (Escobar's abridged criteria). Patients without ready access to a computer and the Internet will be excluded from participating. Also excluded will be individuals with life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, and major psychiatric conditions including psychoses, bipolar disorder, and alcohol or drug abuse. Patients will be required to add no medications to their regimen during the study period (approximately 6 weeks). BASELINE ASSESSMENT. After reading and signing the informed consent, all participants will complete a baseline assessment consisting of questionnaires and a measure delivered by structured interview. Questionnaires will include the Health Assessment Questionnaire (HAQ), Quick Inventory of Depressive Symptomatology (QIDS), the PRIME-MD Somatic Symptoms Scale only (SSS), Positive and Negative Affect Scale (PANAS), Satisfaction with Life Scale (SWLS), and a demographics questionnaire. The structured interview will consist of the Composite International Diagnostic Interview (CIDI). PROCEDURES: Subjects will be randomized to one of two groups. The psychological resilience building group's exercises will be posted on a state-of-the-art website known as "Authentic Happiness". Participants will be provided with the web address and shown how to access the site and the Research Portal where the 6 exercises that are the focus in this and other ongoing studies can be found. The journaling group will be instructed to write weekly for 60-minutes about how they used or plan to use their time over slightly varying time frames: 1) over the previous 24 hours, 2) over the previous week, 3) over the previous year, 4) in the next 24 hours, 5) in the next week and 6) in the next year. The journaling participants will use "PowerJournal". PowerJournal 0.2 for Windows is a downloadable program; once downloaded and installed on the computer, there is no further need for an Internet connection. This is a simple word-processing program, similar in style to Microsoft Word. FOLLOW UP ASSESSMENT. After the intervention is complete, participants will be sent the same questionnaires (plus the Follow-Up Form) as used in the pre-intervention battery by mail and asked to return the questionnaires in the self-addressed, stamped envelope included. We estimate that these questionnaires will take about 30 minutes to complete. This will concluded their participation in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
Keywords
Fibromyalgia, Irritable Bowel, Chronic Fatigue, Medically Unexplained Symptoms, Resilience Building Exercises, Depression, Well-Being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Computer-based exercises to be executed at home.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Computer-based exercises to be executed at home.
Intervention Type
Behavioral
Intervention Name(s)
Resilience Building Exercises
Intervention Description
Weekly exercises for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Journaling
Intervention Description
Weekly exercises for 6 weeks
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms
Time Frame
Baseline and 6 weeks
Title
Positive and Negative Affect Scale
Time Frame
Baseline and 6 weeks
Title
Satisfaction with Life Scale
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire
Time Frame
Baseline and 6 weeks
Title
Health Assessment Questionnaire
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Qualified patients will be primary care patients who meet the following inclusion and exclusion criteria: Patients between the ages of 18 and 75 seeking medical care for physical symptoms (i.e., persistent fatigue, pain complaints, and gastrointestinal, cardiovascular or musculoskeletal symptoms). No major medical illness to explain symptom(s) is found after detailed physical and laboratory assessment. Patients with common disorders such as hypertension, asthma, diabetes, low back strain, etc., will be included if in the opinion of the physician the presenting physical symptoms are not due to the underlying disorder. In order to enter the study, patients must meet criteria for at least 4 medically unexplained symptoms out of the 42 somatic symptoms listed in the Composite International Diagnostic Interview (CIDI) rated as currently present if males and at least 6 symptoms if females (Escobar's abridged criteria). Exclusion Criteria: Patients without ready access to a computer and the Internet will be excluded from participating. Also excluded will be individuals with life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, and major psychiatric conditions including psychoses, bipolar disorder, and alcohol or drug abuse. Patients will be required to add no medications to their regimen during the study period (approximately 6 weeks).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afton L Hassett, Psy.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Links:
URL
http://rwjms.umdnj.edu/
Description
Robert Wood Johnson Medical School

Learn more about this trial

A Computer-Based Intervention for Medically Unexplained Physical Symptoms

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