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

NCT02151500 | Completed

• 1 other identifier: WSU.HIC.036514B3E
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatoform Disorders

Keywords

Medically Unexplained Symptoms (MUPS); Somatoform disorders; Chronic pain; Somatic symptoms; Emotional processing; Primary Care

Outcome Measures

Primary Outcomes (1)

• Symptom Interpretation Questionnaire (SIQ)

  Change from baseline symptom attribution at 6-weeks

Secondary Outcomes (12)

• 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

Study Arms (2)

Stress and Health Interview

EXPERIMENTAL

Stress and Health Interview is an experiential assessment technique

Behavioral: Stress and Health Interview

Wait-list Control

NO INTERVENTION

Standard medical care until the 6-week follow-up is completed

Interventions

Stress and Health Interview BEHAVIORAL

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.

Stress and Health Interview

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Conditions that could interfere with the interview:
• non-English speaking
• psychosis
• dementia
• mental impairment
• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University Family Medicine Clinic

Rochester Hills, Michigan, 48307, United States

Location

Related Publications (1)

• 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.

  PMID: 29154608 DERIVED

MeSH Terms

Conditions

Somatoform Disorders; Medically Unexplained Symptoms; Chronic Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Mark A Lumley, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (1)