A Computer-Based Intervention for Medically Unexplained Physical Symptoms
Condition: Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic; Irritable Bowel Syndrome; Syndrome; Fatigue
Study type: Interventional

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.
    

Intervention name(s): Resilience Building Exercises; Journaling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly exercises for 6 weeks; Weekly exercises for 6 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibromyalgia; Irritable Bowel; Chronic Fatigue; Medically Unexplained Symptoms; Resilience Building Exercises; Depression; Well-Being