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Completed

NCT Number: NCT02151500

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University Family Medicine Clinic

Rochester Hills, Michigan, 48307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Symptom Interpretation Questionnaire (SIQ)

    Time frame: Change from baseline symptom attribution at 6-weeks

Secondary outcomes

  1. Patient Health Questionnaire-15 (PHQ-15)

    Time frame: Change from baseline in symptom severity at 6-weeks

  2. Brief Pain Inventory (BPI)

    Time frame: Change from baseline pain at 6-weeks

  3. Brief Symptom Inventory (BSI)

    Time frame: Change from baseline symptoms at 6-weeks

  4. Insomnia Severity Scale (ISI)

    Time frame: Change from baseline insomnia at 6-weeks

  5. Brief Fatigue Inventory

    Time frame: Change from baseline fatigue at 6-weeks

  6. Satisfaction with Life Scale (SWLS)

    Time frame: Change from baseline life satisfaction at 6-weeks

  7. Emotional Approach Coping Scale (EAC)

    Time frame: Change from baseline emotional approach coping at 6-weeks

  8. Emotional Processing Scale (EPS)

    Time frame: Change from baseline emotional processing at 6-weeks

  9. Inventory of Interpersonal Problems Scale (IIP-32)

    Time frame: Change from baseline interpersonal problems at 6-weeks

  10. Pain Catastrophizing Scale (PCS)

    Time frame: Change from baseline pain catastrophizing at 6-weeks

  11. Change Assessment Questionnaire

    Time frame: Changes from baseline stage of change at 6-weeks

  12. McGill Pain Questionnaire (SF-MPQ-2)

    Time frame: Change from baseline pain at 6-weeks

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 30, 2014
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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