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

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.

Study Overview

• Status: Completed
• Conditions: Somatoform Disorders
• Intervention / Treatment: Behavioral: Stress and Health Interview

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Wayne State University Family Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress and Health Interview; Stress and Health Interview is an experiential assessment technique	Behavioral: Stress and Health Interview; A stress and health interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms; b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations.
No Intervention: Wait-list Control; Standard medical care until the 6-week follow-up is completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom Interpretation Questionnaire (SIQ)	Change from baseline symptom attribution at 6-weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wayne State University

Publications and helpful links

General Publications

• Ziadni MS, Carty JN, Doherty HK, Porcerelli JH, Rapport LJ, Schubiner H, Lumley MA. A life-stress, emotional awareness, and expression interview for primary care patients with medically unexplained symptoms: A randomized controlled trial. Health Psychol. 2018 Mar;37(3):282-290. doi: 10.1037/hea0000566. Epub 2017 Nov 20.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Primary Care; Chronic pain; Emotional processing; Somatoform disorders; Medically Unexplained Symptoms (MUPS); Somatic symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: WSU.HIC.036514B3E