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

Primary Purpose

Somatoform Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress and Health Interview
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatoform Disorders focused on measuring Medically Unexplained Symptoms (MUPS), Somatoform disorders, Chronic pain, Somatic symptoms, Emotional processing, Primary Care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wayne State University Family Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stress and Health Interview

Wait-list Control

Arm Description

Stress and Health Interview is an experiential assessment technique

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

Outcomes

Primary Outcome Measures

Symptom Interpretation Questionnaire (SIQ)

Secondary Outcome Measures

Patient Health Questionnaire-15 (PHQ-15)
Brief Pain Inventory (BPI)
Brief Symptom Inventory (BSI)
Insomnia Severity Scale (ISI)
Brief Fatigue Inventory
Satisfaction with Life Scale (SWLS)
Emotional Approach Coping Scale (EAC)
Emotional Processing Scale (EPS)
Inventory of Interpersonal Problems Scale (IIP-32)
Pain Catastrophizing Scale (PCS)
Change Assessment Questionnaire
McGill Pain Questionnaire (SF-MPQ-2)

Full Information

First Posted
May 27, 2014
Last Updated
December 7, 2015
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT02151500
Brief Title
Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms
Official Title
Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders
Keywords
Medically Unexplained Symptoms (MUPS), Somatoform disorders, Chronic pain, Somatic symptoms, Emotional processing, Primary Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress and Health Interview
Arm Type
Experimental
Arm Description
Stress and Health Interview is an experiential assessment technique
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Standard medical care until the 6-week follow-up is completed
Intervention Type
Behavioral
Intervention Name(s)
Stress and Health Interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Interpretation Questionnaire (SIQ)
Time Frame
Change from baseline symptom attribution at 6-weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-15 (PHQ-15)
Time Frame
Change from baseline in symptom severity at 6-weeks
Title
Brief Pain Inventory (BPI)
Time Frame
Change from baseline pain at 6-weeks
Title
Brief Symptom Inventory (BSI)
Time Frame
Change from baseline symptoms at 6-weeks
Title
Insomnia Severity Scale (ISI)
Time Frame
Change from baseline insomnia at 6-weeks
Title
Brief Fatigue Inventory
Time Frame
Change from baseline fatigue at 6-weeks
Title
Satisfaction with Life Scale (SWLS)
Time Frame
Change from baseline life satisfaction at 6-weeks
Title
Emotional Approach Coping Scale (EAC)
Time Frame
Change from baseline emotional approach coping at 6-weeks
Title
Emotional Processing Scale (EPS)
Time Frame
Change from baseline emotional processing at 6-weeks
Title
Inventory of Interpersonal Problems Scale (IIP-32)
Time Frame
Change from baseline interpersonal problems at 6-weeks
Title
Pain Catastrophizing Scale (PCS)
Time Frame
Change from baseline pain catastrophizing at 6-weeks
Title
Change Assessment Questionnaire
Time Frame
Changes from baseline stage of change at 6-weeks
Title
McGill Pain Questionnaire (SF-MPQ-2)
Time Frame
Change from baseline pain at 6-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Lumley, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University Family Medicine Clinic
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29154608
Citation
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.
Results Reference
derived

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

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