FibromyalgiaPhase 2NCT01287481
Pain and Stress Management for Fibromyalgia
A Phase 2 study testing Stress and Emotions, Thoughts and Behaviors and Brain and Body in people with Fibromyalgia, run by Wayne State University at 3 sites in United States.
Trial summary
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Stress and Emotions, Thoughts and Behaviors and Brain and Body
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to Jul 2015
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
- 1990 ACR criteria including tender points
- 2010 ACR modified clinical criteria that does not include tender points
Who cannot join
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- Other serious medical conditions that can impair health status independent of FM
- Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- Alcohol/drug dependence in past 2 years
- Cognitive impairment or dementia
- Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
Show all 9Show fewer
- Unable to fluently read or converse in English
- Planning to move from the area in the next 14 months
- Judgment of principle investigator as not appropriate for this trial or all intervention arms
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48106
Wayne State University
Detroit, Michigan, 48202
St. John Providence Hospital
Southfield, Michigan, 48075
About this study
Official title: Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
- Conditions
- Fibromyalgia
- Being tested
- Stress and Emotions, Thoughts and Behaviors, Brain and Body
- Keywords
- Fibromyalgia, Behavioral interventions, Psychological interventions
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress and EmotionsBehavioural
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Thoughts and BehaviorsBehavioural
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Brain and BodyBehavioural
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
| Study group | Role | What they receive |
|---|---|---|
| Stress and Emotions | Experimental | Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Receives: Behavioral: Stress and Emotions |
| Thoughts and Behaviors | Active comparator | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Receives: Behavioral: Thoughts and Behaviors |
| Brain and Body | Active comparator | Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings. Receives: Behavioral: Brain and Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Secondary outcomes (23)
SF-12
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
PROMIS Fatigue short form
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Pittsburgh Sleep Quality Index
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Center for Epidemiological Studies - Depression Scale
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Generalized Anxiety Disorder - 7
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Positive and Negative Affect Schedule
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Satisfaction with Life Scale
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Multiple Ability Self-Report Questionnaire
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Patient Global Assessment of Change
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Health Care Utilization Scale
Measured: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Real-time Physical Activity (Actiwatch)
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Heart Rate Variability
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Levels of Emotional Awareness Scale
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Emotional Expressivity Scale
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Ambivalence over Emotional Expression
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Impact of Events Scale - Revised
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
BBCA - short form
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Beliefs in Pain Control Questionnaire
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Communication Thoughts and Feelings Questionnaire
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Experimental (thumb nail pressure) threshold and tolerance ratings
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
2010 ACR modified clinical criteria for FM, including widespread pain index
Measured: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, St. John Providence Hospital
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A Lumley, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287481
- Sponsor's protocol ID
- 1R01AR057808
- Status last verified
- Mar 2016
- First submitted
- 2 Nov 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
- ClinicalTrials.gov ID
- NCT01287481
- Acronym / sponsor ID
- 1R01AR057808
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Behavioral interventions, Psychological interventions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, St. John Providence Hospital
- Study start
- May 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Feb 2011 (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.
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress and Emotions | Experimental | Behavioral: Stress and EmotionsSeeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. |
| Thoughts and Behaviors | Active comparator | Behavioral: Thoughts and BehaviorsSeeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. |
| Brain and Body | Active comparator | Behavioral: Brain and BodySeeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
Key exclusion criteria (9 listed)
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- Other serious medical conditions that can impair health status independent of FM
- Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- Alcohol/drug dependence in past 2 years
- Cognitive impairment or dementia
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 EmotionsFocus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. | Behavioural | Stress and Emotions |
| Thoughts and BehaviorsFocus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. | Behavioural | Thoughts and Behaviors |
| Brain and BodyFocus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments. | Behavioural | Brain and Body |
Primary outcome
Brief Pain Inventory
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
23 secondary outcomes
SF-12
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
PROMIS Fatigue short form
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Pittsburgh Sleep Quality Index
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Center for Epidemiological Studies - Depression Scale
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Generalized Anxiety Disorder - 7
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Positive and Negative Affect Schedule
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Satisfaction with Life Scale
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Multiple Ability Self-Report Questionnaire
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Patient Global Assessment of Change
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Health Care Utilization Scale
Time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Real-time Physical Activity (Actiwatch)
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Heart Rate Variability
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Levels of Emotional Awareness Scale
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Emotional Expressivity Scale
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Ambivalence over Emotional Expression
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Impact of Events Scale - Revised
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
BBCA - short form
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Beliefs in Pain Control Questionnaire
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Communication Thoughts and Feelings Questionnaire
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Experimental (thumb nail pressure) threshold and tolerance ratings
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
2010 ACR modified clinical criteria for FM, including widespread pain index
Time frame: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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 17 Mar 2016.
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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, Ph.D. principal investigator
Wayne State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stress and Emotions, Thoughts and Behaviors and Brain and Body in people with Fibromyalgia, run by Wayne State University at 3 sites 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 3 inclusion and 9 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Brief Pain Inventory (time frame: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016.