Clinical trial NCT02151500: 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
Overall status: COMPLETED
Phase: NA
Conditions: Somatoform Disorders
Keywords: Medically Unexplained Symptoms (MUPS)
Somatoform disorders
Chronic pain
Somatic symptoms
Emotional processing
Primary Care
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Symptom Interpretation Questionnaire (SIQ)
timeFrame: Change from baseline symptom attribution at 6-weeks
Secondary outcomes:
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Change from baseline in symptom severity at 6-weeks
measure: Brief Pain Inventory (BPI)
timeFrame: Change from baseline pain at 6-weeks
measure: Brief Symptom Inventory (BSI)
timeFrame: Change from baseline symptoms at 6-weeks
measure: Insomnia Severity Scale (ISI)
timeFrame: Change from baseline insomnia at 6-weeks
measure: Brief Fatigue Inventory
timeFrame: Change from baseline fatigue at 6-weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Change from baseline life satisfaction at 6-weeks
measure: Emotional Approach Coping Scale (EAC)
timeFrame: Change from baseline emotional approach coping at 6-weeks
measure: Emotional Processing Scale (EPS)
timeFrame: Change from baseline emotional processing at 6-weeks
measure: Inventory of Interpersonal Problems Scale (IIP-32)
timeFrame: Change from baseline interpersonal problems at 6-weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Change from baseline pain catastrophizing at 6-weeks
measure: Change Assessment Questionnaire
timeFrame: Changes from baseline stage of change at 6-weeks
measure: McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: Change from baseline pain at 6-weeks
Other outcomes:
Locations:
city: Rochester Hills
country: United States
facility: Wayne State University Family Medicine Clinic
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A Lumley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.