A Computer-Based Intervention for Medically Unexplained Physical Symptoms

NCT00468013 | Completed

• 1 other identifier: P15-MUPS-8484
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome

Keywords

Fibromyalgia; Irritable Bowel; Chronic Fatigue; Medically Unexplained Symptoms; Resilience Building Exercises; Depression; Well-Being

Outcome Measures

Primary Outcomes (3)

• Quick Inventory of Depressive Symptoms

  Baseline and 6 weeks

• Positive and Negative Affect Scale

  Baseline and 6 weeks

• Satisfaction with Life Scale

  Baseline and 6 weeks

Secondary Outcomes (2)

• Patient Health Questionnaire

  Baseline and 6 weeks

• Health Assessment Questionnaire

  Baseline and 6 weeks

Study Arms (2)

1

EXPERIMENTAL

Computer-based exercises to be executed at home.

Behavioral: Resilience Building Exercises

2

SHAM COMPARATOR

Computer-based exercises to be executed at home.

Behavioral: Journaling

Interventions

Resilience Building Exercises BEHAVIORAL

Weekly exercises for 6 weeks

1

Journaling BEHAVIORAL

Weekly exercises for 6 weeks

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Related Links

• Robert Wood Johnson Medical School

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Fatigue Syndrome, Chronic; Medically Unexplained Symptoms; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Afton L Hassett, Psy.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

US (1)