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

December 7, 2015 updated by: Mark A. Lumley, Wayne State University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Symptom Interpretation Questionnaire (SIQ)
Time Frame: Change from baseline symptom attribution at 6-weeks
Change from baseline symptom attribution at 6-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient Health Questionnaire-15 (PHQ-15)
Time Frame: Change from baseline in symptom severity at 6-weeks
Change from baseline in symptom severity at 6-weeks
Brief Pain Inventory (BPI)
Time Frame: Change from baseline pain at 6-weeks
Change from baseline pain at 6-weeks
Brief Symptom Inventory (BSI)
Time Frame: Change from baseline symptoms at 6-weeks
Change from baseline symptoms at 6-weeks
Insomnia Severity Scale (ISI)
Time Frame: Change from baseline insomnia at 6-weeks
Change from baseline insomnia at 6-weeks
Brief Fatigue Inventory
Time Frame: Change from baseline fatigue at 6-weeks
Change from baseline fatigue at 6-weeks
Satisfaction with Life Scale (SWLS)
Time Frame: Change from baseline life satisfaction at 6-weeks
Change from baseline life satisfaction at 6-weeks
Emotional Approach Coping Scale (EAC)
Time Frame: Change from baseline emotional approach coping at 6-weeks
Change from baseline emotional approach coping at 6-weeks
Emotional Processing Scale (EPS)
Time Frame: Change from baseline emotional processing at 6-weeks
Change from baseline emotional processing at 6-weeks
Inventory of Interpersonal Problems Scale (IIP-32)
Time Frame: Change from baseline interpersonal problems at 6-weeks
Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale (PCS)
Time Frame: Change from baseline pain catastrophizing at 6-weeks
Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Time Frame: Changes from baseline stage of change at 6-weeks
Changes from baseline stage of change at 6-weeks
McGill Pain Questionnaire (SF-MPQ-2)
Time Frame: Change from baseline pain at 6-weeks
Change from baseline pain at 6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WSU.HIC.036514B3E

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