Somatoform Disorders Clinical Trial
Official title:
Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms
Verified date | December 2015 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Participants must score above 10 (moderate range) on the Patient Health Questionnaire-15, which is a measure of a range of medical symptoms that are often medically unexplained. Exclusion Criteria: 1. Conditions that could interfere with the interview: - non-English speaking - psychosis - dementia - mental impairment 2. The presence of disease or injury that could account for the physical symptoms. - Examples: autoimmune disease, bodily injury, serious infection, cancer, heart disease, COPD, post-stroke. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University Family Medicine Clinic | Rochester Hills | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom Interpretation Questionnaire (SIQ) | Change from baseline symptom attribution at 6-weeks | No | |
Secondary | Patient Health Questionnaire-15 (PHQ-15) | Change from baseline in symptom severity at 6-weeks | No | |
Secondary | Brief Pain Inventory (BPI) | Change from baseline pain at 6-weeks | No | |
Secondary | Brief Symptom Inventory (BSI) | Change from baseline symptoms at 6-weeks | No | |
Secondary | Insomnia Severity Scale (ISI) | Change from baseline insomnia at 6-weeks | No | |
Secondary | Brief Fatigue Inventory | Change from baseline fatigue at 6-weeks | No | |
Secondary | Satisfaction with Life Scale (SWLS) | Change from baseline life satisfaction at 6-weeks | No | |
Secondary | Emotional Approach Coping Scale (EAC) | Change from baseline emotional approach coping at 6-weeks | No | |
Secondary | Emotional Processing Scale (EPS) | Change from baseline emotional processing at 6-weeks | No | |
Secondary | Inventory of Interpersonal Problems Scale (IIP-32) | Change from baseline interpersonal problems at 6-weeks | No | |
Secondary | Pain Catastrophizing Scale (PCS) | Change from baseline pain catastrophizing at 6-weeks | No | |
Secondary | Change Assessment Questionnaire | Changes from baseline stage of change at 6-weeks | No | |
Secondary | McGill Pain Questionnaire (SF-MPQ-2) | Change from baseline pain at 6-weeks | No |
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