A Computer-Based Intervention for Medically Unexplained Physical Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Rutgers, The State University of New Jersey.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00468013
First received: April 27, 2007
Last updated: March 4, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Behavioral: Resilience Building Exercises
Behavioral: Journaling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Quick Inventory of Depressive Symptoms [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Scale [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Health Questionnaire [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Computer-based exercises to be executed at home.
Behavioral: Resilience Building Exercises
Weekly exercises for 6 weeks
Sham Comparator: 2
Computer-based exercises to be executed at home.
Behavioral: Journaling
Weekly exercises for 6 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468013

Locations
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Afton L Hassett, Psy.D. Rutgers, The State University of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Afton L. Hassett, Psy.D., UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00468013     History of Changes
Other Study ID Numbers: P15-MUPS-8484
Study First Received: April 27, 2007
Last Updated: March 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Fibromyalgia
Irritable Bowel
Chronic Fatigue
Medically Unexplained Symptoms
Resilience Building Exercises
Depression
Well-Being

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Fibromyalgia
Irritable Bowel Syndrome
Myofascial Pain Syndromes
Syndrome
Central Nervous System Diseases
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Encephalomyelitis
Gastrointestinal Diseases
Intestinal Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014