FibromyalgiaNCT00437411
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
A study testing Affective Self-Awareness workshop in people with Fibromyalgia, run by Mike Hsu at 1 site in United States.
Trial summary
The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Affective Self-Awareness workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
- at least 18 years of age.
- have access to transportation to and from Providence Hospital, Southfield, MI.
Who cannot join
- co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
- any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
- changes in medication regimen within one month prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. John Providence Hospital
Southfield, Michigan, 48075
About this study
The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.
Read the detailed description
The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.
Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:
- three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
- usual care
- Conditions
- Fibromyalgia
- Being tested
- Affective Self-Awareness workshop
- Keywords
- Fibromyalgia, Affect, Pain, Fatigue, Sleep, Stress, Quality of Life, Stress, Psychological, Psychophysiology, Randomized Controlled Trials
- Medical subject headings
- Fibromyalgia, Pain, Fatigue, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective Self-Awareness workshopBehavioural
Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices.
| Study group | Role | What they receive |
|---|---|---|
| Workshop | Experimental | Affective Self Awareness intervention Receives: Behavioral: Affective Self-Awareness workshop |
| Control | No intervention | Waiting-list control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain according to the Brief Pain Inventory
Measured: 6 months
Secondary outcomes (8)
Change in Multi-dimensional Fatigue Inventory
Measured: 6 months
Medical Outcomes Study sleep subscale
Measured: 6 months
Perceived Stress Scale
Measured: 6 months
SF-36 Physical Functional Status
Measured: 6 months
Profile of Mood States
Measured: 6 months
Tender point count
Measured: 6 months
Dolorimeter tender point score
Measured: 6 months
Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionNov 2008
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike Hsu
- Sponsor type
- University, hospital or other
- Collaborators
- St. John Providence Hospital, Blue Care Network of Michigan
- Responsible party
- Sponsor-investigator, Mike Hsu, University of Michigan
- Investigators
- Michael C Hsu, MD, Principal investigator, University of Michigan Chronic Pain and Fatigue Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437411
- Sponsor's protocol ID
- UM-HUM00008669
- Status last verified
- Oct 2016
- First submitted
- 20 Feb 2007
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hsu MC, Schubiner H, Lumley MA, Stracks JS, Clauw DJ, Williams DA. Sustained pain reduction through affective self-awareness in fibromyalgia: a randomized controlled trial. J Gen Intern Med. 2010 Oct;25(10):1064-70. doi: 10.1007/s11606-010-1418-6. Epub 2010 Jun 8.
PubMed 20532650
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00437411
- Acronym / sponsor ID
- UM-HUM00008669
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Affect, Pain, Fatigue, Sleep, Stress, Quality of Life, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mike HsuUniversity, hospital or other
- Collaborators
- St. John Providence Hospital, Blue Care Network of Michigan
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Feb 2007 (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 investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.
Detailed description
The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.
Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:
- three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
- usual care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workshop | Experimental | Behavioral: Affective Self-Awareness workshopAffective Self Awareness intervention |
| Control | No intervention | –Waiting-list control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
- at least 18 years of age.
- have access to transportation to and from Providence Hospital, Southfield, MI.
Key exclusion criteria (3 listed)
- co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
- any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
- changes in medication regimen within one month prior to enrollment.
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 |
|---|---|---|
| Affective Self-Awareness workshopAffective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices. | Behavioural | Workshop |
Primary outcome
Change in average pain according to the Brief Pain Inventory
Time frame: 6 months
8 secondary outcomes
Change in Multi-dimensional Fatigue Inventory
Time frame: 6 months
Medical Outcomes Study sleep subscale
Time frame: 6 months
Perceived Stress Scale
Time frame: 6 months
SF-36 Physical Functional Status
Time frame: 6 months
Profile of Mood States
Time frame: 6 months
Tender point count
Time frame: 6 months
Dolorimeter tender point score
Time frame: 6 months
Ascending and Multiple Random Staircase thumbnail sensitivity thresholds
Time frame: 6 months
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 24 Oct 2016.
- Derived from this study: PubMed 20532650Hsu MC, Schubiner H, Lumley MA, Stracks JS, Clauw DJ, Williams DA. Sustained pain reduction through affective self-awareness in fibromyalgia: a randomized controlled trial. J Gen Intern Med. 2010 Oct;25(10):1064-70. doi: 10.1007/s11606-010-1418-6. Epub 2010 Jun 8.
- Individual participant dataSharing planned: No
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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.
Michael C Hsu, MD principal investigator
University of Michigan Chronic Pain and Fatigue Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective Self-Awareness workshop in people with Fibromyalgia, run by Mike Hsu 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 3 inclusion and 3 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 24 Oct 2016. 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?
Change in average pain according to the Brief Pain Inventory (time frame: 6 months). 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 NCT00437411, 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 24 Oct 2016.