Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms

Not Applicable

Completed

• Conditions: Somatoform Disorders
• Interventions: Behavioral: Stress and Health Interview

• Registration Number: NCT02151500
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed Description

Emotional stress, particularly when a patients inhibits their experiences and feelings, contributes to physical symptoms. However, primary care patients with medically unexplained symptoms are rarely assessed for the stress and emotions in an comprehensive manner. 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 with medically unexplained physical symptoms. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The interview will review patients health history, psychosocial history, make links between the two, and help patients identify and express emotions related to conflicts or victimization. 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress and Health Interview	Stress and Health Interview	Stress and Health Interview is an experiential assessment technique

Primary Outcome Measures

Name	Time	Method
Symptom Interpretation Questionnaire (SIQ)	Change from baseline symptom attribution at 6-weeks

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	Change from baseline pain at 6-weeks
Brief Fatigue Inventory	Change from baseline fatigue at 6-weeks
Emotional Processing Scale (EPS)	Change from baseline emotional processing at 6-weeks
Change Assessment Questionnaire	Changes from baseline stage of change at 6-weeks
Pain Catastrophizing Scale (PCS)	Change from baseline pain catastrophizing at 6-weeks
Patient Health Questionnaire-15 (PHQ-15)	Change from baseline in symptom severity at 6-weeks
Emotional Approach Coping Scale (EAC)	Change from baseline emotional approach coping at 6-weeks
Inventory of Interpersonal Problems Scale (IIP-32)	Change from baseline interpersonal problems at 6-weeks
Brief Symptom Inventory (BSI)	Change from baseline symptoms at 6-weeks
Satisfaction with Life Scale (SWLS)	Change from baseline life satisfaction at 6-weeks
Insomnia Severity Scale (ISI)	Change from baseline insomnia at 6-weeks
McGill Pain Questionnaire (SF-MPQ-2)	Change from baseline pain at 6-weeks

Trial Locations

Locations (1)

Wayne State University Family Medicine Clinic; 🇺🇸 Rochester Hills, Michigan, United States