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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02151500
Other study ID # WSU.HIC.036514B3E
Secondary ID
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


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
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