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

Somatoform Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151500
• Other study ID #: WSU.HIC.036514B3E
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: December 7, 2015
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatoform Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Wayne State University Family Medicine Clinic	Rochester Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Interpretation Questionnaire (SIQ)		Change from baseline symptom attribution at 6-weeks	No
Secondary	Patient Health Questionnaire-15 (PHQ-15)		Change from baseline in symptom severity at 6-weeks	No
Secondary	Brief Pain Inventory (BPI)		Change from baseline pain at 6-weeks	No
Secondary	Brief Symptom Inventory (BSI)		Change from baseline symptoms at 6-weeks	No
Secondary	Insomnia Severity Scale (ISI)		Change from baseline insomnia at 6-weeks	No
Secondary	Brief Fatigue Inventory		Change from baseline fatigue at 6-weeks	No
Secondary	Satisfaction with Life Scale (SWLS)		Change from baseline life satisfaction at 6-weeks	No
Secondary	Emotional Approach Coping Scale (EAC)		Change from baseline emotional approach coping at 6-weeks	No
Secondary	Emotional Processing Scale (EPS)		Change from baseline emotional processing at 6-weeks	No
Secondary	Inventory of Interpersonal Problems Scale (IIP-32)		Change from baseline interpersonal problems at 6-weeks	No
Secondary	Pain Catastrophizing Scale (PCS)		Change from baseline pain catastrophizing at 6-weeks	No
Secondary	Change Assessment Questionnaire		Changes from baseline stage of change at 6-weeks	No
Secondary	McGill Pain Questionnaire (SF-MPQ-2)		Change from baseline pain at 6-weeks	No