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

Sponsor

Wayne State University (Other)

Overall Status

Completed

CT.gov ID

NCT02151500

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Somatoform Disorders	Behavioral: Stress and Health Interview	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Symptom Interpretation Questionnaire (SIQ) [Change from baseline symptom attribution at 6-weeks]

Secondary Outcome Measures

Patient Health Questionnaire-15 (PHQ-15) [Change from baseline in symptom severity at 6-weeks]
Brief Pain Inventory (BPI) [Change from baseline pain at 6-weeks]
Brief Symptom Inventory (BSI) [Change from baseline symptoms at 6-weeks]
Insomnia Severity Scale (ISI) [Change from baseline insomnia at 6-weeks]
Brief Fatigue Inventory [Change from baseline fatigue at 6-weeks]
Satisfaction with Life Scale (SWLS) [Change from baseline life satisfaction at 6-weeks]
Emotional Approach Coping Scale (EAC) [Change from baseline emotional approach coping at 6-weeks]
Emotional Processing Scale (EPS) [Change from baseline emotional processing at 6-weeks]
Inventory of Interpersonal Problems Scale (IIP-32) [Change from baseline interpersonal problems at 6-weeks]
Pain Catastrophizing Scale (PCS) [Change from baseline pain catastrophizing at 6-weeks]
Change Assessment Questionnaire [Changes from baseline stage of change at 6-weeks]
McGill Pain Questionnaire (SF-MPQ-2) [Change from baseline pain at 6-weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.