Somatoform DisordersNCT02151500
Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms
A study testing Stress and Health Interview in people with Somatoform Disorders, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Somatoform Disorders
- What is being tested?
- Stress and Health Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University Family Medicine Clinic
Rochester Hills, Michigan, 48307
About this study
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.
Read the 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.
- Conditions
- Somatoform Disorders
- Being tested
- Stress and Health Interview
- Keywords
- Medically Unexplained Symptoms (MUPS), Somatoform disorders, Chronic pain, Somatic symptoms, Emotional processing, Primary Care
- Medical subject headings
- Somatoform Disorders, Medically Unexplained Symptoms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress and Health InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress and Health Interview | Experimental | Stress and Health Interview is an experiential assessment technique Receives: Behavioral: Stress and Health Interview |
| Wait-list Control | No intervention | Standard medical care until the 6-week follow-up is completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Interpretation Questionnaire (SIQ)
Measured: Change from baseline symptom attribution at 6-weeks
Secondary outcomes (12)
Patient Health Questionnaire-15 (PHQ-15)
Measured: Change from baseline in symptom severity at 6-weeks
Brief Pain Inventory (BPI)
Measured: Change from baseline pain at 6-weeks
Brief Symptom Inventory (BSI)
Measured: Change from baseline symptoms at 6-weeks
Insomnia Severity Scale (ISI)
Measured: Change from baseline insomnia at 6-weeks
Brief Fatigue Inventory
Measured: Change from baseline fatigue at 6-weeks
Satisfaction with Life Scale (SWLS)
Measured: Change from baseline life satisfaction at 6-weeks
Emotional Approach Coping Scale (EAC)
Measured: Change from baseline emotional approach coping at 6-weeks
Emotional Processing Scale (EPS)
Measured: Change from baseline emotional processing at 6-weeks
Inventory of Interpersonal Problems Scale (IIP-32)
Measured: Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale (PCS)
Measured: Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Measured: Changes from baseline stage of change at 6-weeks
McGill Pain Questionnaire (SF-MPQ-2)
Measured: Change from baseline pain at 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatoform DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A Lumley, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151500
- Sponsor's protocol ID
- WSU.HIC.036514B3E
- Status last verified
- Dec 2015
- First submitted
- 27 May 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29154608
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms
- ClinicalTrials.gov ID
- NCT02151500
- Acronym / sponsor ID
- WSU.HIC.036514B3E
- Conditions
- Somatoform Disorders
- Keywords
- Medically Unexplained Symptoms (MUPS), Somatoform disorders, Chronic pain, Somatic symptoms, Emotional processing, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress and Health Interview | Experimental | Behavioral: Stress and Health InterviewStress and Health Interview is an experiential assessment technique |
| Wait-list Control | No intervention | –Standard medical care until the 6-week follow-up is completed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Conditions that could interfere with the interview:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress and Health InterviewA 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. | Behavioural | Stress and Health Interview |
Primary outcome
Symptom Interpretation Questionnaire (SIQ)
Time frame: Change from baseline symptom attribution at 6-weeks
12 secondary outcomes
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Change from baseline in symptom severity at 6-weeks
Brief Pain Inventory (BPI)
Time frame: Change from baseline pain at 6-weeks
Brief Symptom Inventory (BSI)
Time frame: Change from baseline symptoms at 6-weeks
Insomnia Severity Scale (ISI)
Time frame: Change from baseline insomnia at 6-weeks
Brief Fatigue Inventory
Time frame: Change from baseline fatigue at 6-weeks
Satisfaction with Life Scale (SWLS)
Time frame: Change from baseline life satisfaction at 6-weeks
Emotional Approach Coping Scale (EAC)
Time frame: Change from baseline emotional approach coping at 6-weeks
Emotional Processing Scale (EPS)
Time frame: Change from baseline emotional processing at 6-weeks
Inventory of Interpersonal Problems Scale (IIP-32)
Time frame: Change from baseline interpersonal problems at 6-weeks
Pain Catastrophizing Scale (PCS)
Time frame: Change from baseline pain catastrophizing at 6-weeks
Change Assessment Questionnaire
Time frame: Changes from baseline stage of change at 6-weeks
McGill Pain Questionnaire (SF-MPQ-2)
Time frame: Change from baseline pain at 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Derived from this study: PubMed 29154608Ziadni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Lumley, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress and Health Interview in people with Somatoform Disorders, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Interpretation Questionnaire (SIQ) (time frame: Change from baseline symptom attribution at 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.