Chronic Spine PainNCT03304613
Resilience Skills Self-Management for Chronic Pain.
A study testing Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management and Promoting Resilience through Innovative Self-Management in people with Chronic Spine Pain and Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial summary
The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Spine Pain, Fibromyalgia
- What is being tested?
- Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management and Promoting Resilience through Innovative Self-Management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 21 Mar 2023
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary back or spine pain diagnosis from the Back \& Pain Center at University of Michigan.
- High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.
Who cannot join
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
- Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
- Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
- Planned major surgery in the next 12 months;
- Pregnancy or taking steroid medications
- Recent pain interventions ≤6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
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- Cognitive impairment or dementia (inability to give consent or meaningfully participate);
- Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
- Unable to read or fluently converse in English;
- Planning to move from the area in next 14 months;
- In the judgment of the PIs the individual would not be able to meaningfully participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Back & Pain Center, University of Michigan
Ann Arbor, Michigan, 48106
About this study
The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4
- Conditions
- Chronic Spine Pain, Fibromyalgia
- Being tested
- Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management, Promoting Resilience through Innovative Self-Management
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Cognitive Behavioral Therapy (e-CBT) Self-ManagementBehavioural
Already noted.
Promoting Resilience through Innovative Self-ManagementBehavioural
Also called PRISM
Already noted.
| Study group | Role | What they receive |
|---|---|---|
| Standard Web-based Cognitive Behavioral Therapy (e-CBT) | Active comparator | Patients randomized to e-CBT will undergo "Standard Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management Program" and meet with a study medical assistant (MA) for an orientation session. The MA provides an overview of the program, explains the rationale for treatment, and directs them to the FibroGuide website. FibroGuide features the CBT modules that will be used by both groups. Patients will complete one module per week. Materials needed for the 8-week intervention including the instructions for each activity and forms for the written aspects of an activity (worksheets) will be provided in the first visit and available online. The FibroGuide website evolved from the evidence-based website Living Well with Fibromyalgia that has established efficacy for improving functional status and reducing pain. Receives: Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management |
| Resilience-Enhanced web-based CBT Program | Experimental | Patients randomized to PRISM will undergo "Promoting Resilience through Innovative Self-Management" (PRISM) and meet with the MA for an orientation session. The MA describes the program, explains the rationale for treatment, and directs them to the FibroGuide and PRISM websites. Materials and worksheets are provided in the first visit and available online. The e-CBT elements retained are the core elements of CBT for pain, while the resilience-based activities capitalize on the best practices for positive activities interventions including having multiple overlapping activities, making favored activities standard practice beyond the study and having a coaching component. Receives: Behavioral: Promoting Resilience through Innovative Self-Management |
| Usual Care | No intervention | Patients randomized to the usual care only group will have no contact with the study MAs. Usual care patients return for the same follow-up assessments (and electronic medical record review) at 8 weeks and at 6 and 12 months. Whereas major surgery including surgeries for pain, are exclusion criteria, spine and pain injections will be permitted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.
Measured: At 8-week assessment point
Secondary outcomes (13)
Brief Pain Inventory (BPI)
The BPI is a 15-item self-report measure that has been validated for use in a wide variety of pain states. The BPI assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain.
Measured: At 8-week assessment point
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a widely used, valid and reliable measure of global sleep quality and sleep-related symptoms.149 The 19-items yield 7 component-scores that reflect common sleep problems such as subjective sleep quality, sleep disturbance and use of sleep medication.
Measured: At 8-week assessment point
PROMIS Fatigue-Short Form
The PROMIS Fatigue-Short Form consists of 8 items that assess the impact and experience of fatigue in the past week. It uses a 5-point Likert-like scale with response options that range from "Not at all" to "Very much." A raw score is calculated by summing scores across items then a conversion table is used to calculate T-scores with higher scores indicating greater fatigue.
Measured: At 8-week assessment point
Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
The MISCI is a 10-item measure based upon items developed for PROMIS that assesses perceived difficulties within 5 domains: mental clarity, memory, language, executive functioning, and attention/concentration.
Measured: At 8-week assessment point
Subjective well-being
Subjective well-being has at least three components: positive affective appraisal, negative affective appraisal, and life satisfaction. Composite scores for well-being will be calculated using scores obtained on Positive and Negative Affect Schedule (PANAS) and the Satisfaction with Life Scale (SWLS).
Measured: At 8-week assessment point
Pain Catastrophizing Scale (PCS)
. Catastrophizing will be measured using the Pain Catastrophizing Scale (PCS).144 The PCS contains 13 statements regarding various beliefs about pain. A total score is obtained by summing the responses to all items.
Measured: At 8-week assessment point
Patient Health Questionnaire 9-item (PHQ-9):
The PHQ-9 is a 9-item multipurpose instrument that has utility for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: At 8-week assessment point
Generalized Anxiety Disorder 7-item (GAD-7)
The GAD-7 is a 7-item measure of anxiety. It has good reliability, criterion, construct, and factorial validity. It has a sensitivity of 89% and specificity of 82% for generalized anxiety disorder.
Measured: At 8-week assessment point
Perceived Stress Scale (PSS)
The 10-item PSS will be used evaluate an individual's assessment of stress. Participants rate stress on a numeric rating scale from 0 to 10 where higher scores reflect higher levels of stress. Total scores range from 0 to 100.
Measured: At 8-week assessment point
Six-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. Participants are instructed to walk as far as possible, but allowed to self-pace and rest as needed.
Measured: At 8-week assessment point
Sit-to-Stand Test
Patients are instructed to stand up 5 times from a chair without arms as fast as possible. The test is repeated twice as this improves reliability. Average time is calculated in seconds.
Measured: At 8-week assessment point
Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method
The Blackburn lab collaborated with Biorad to develop a highly sensitive, quantitative and high throughput droplet digital PCR (ddPCR) method to measure telomerase activity in unstimulated PBMCs. This new method has over 10-fold increased sensitivity and over 5-fold increased throughput compared to the currently used gel method.
Measured: At 8-week assessment point
Telomere length
The DNA will then be analyzed for telomere length using a quantitative polymerase chain reaction (PCR) measurement assay adapted from the methods described by Cawthon with modifications by Lin (Co-I).
Measured: At 1 year assessment point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start16 Nov 2017
- Primary completion28 Feb 2022
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spine PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60).
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Afton Hassett, Psy.D., University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304613
- Sponsor's protocol ID
- HUM00124722
- Other IDs
- 5R01NR017096-05
- Status last verified
- Nov 2023
- First submitted
- 3 Oct 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Skills Self-Management for Chronic Pain.
- ClinicalTrials.gov ID
- NCT03304613
- Acronym / sponsor ID
- HUM00124722
- Conditions
- Chronic Spine Pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 9 Oct 2017 (actual)
- 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 will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60).
| Arm | Type | Receives |
|---|---|---|
| Standard Web-based Cognitive Behavioral Therapy (e-CBT) | Active comparator | Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-ManagementPatients randomized to e-CBT will undergo "Standard Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management Program" and meet with a study medical assistant (MA) for an orientation session. The MA provides an overview of the program, explains the rationale for treatment, and directs them to the FibroGuide website. FibroGuide features the CBT modules that will be used by both groups. Patients will complete one module per week. Materials needed for the 8-week intervention including the instructions for each activity and forms for the written aspects of an activity (worksheets) will be provided in the first visit and available online. The FibroGuide website evolved from the evidence-based website Living Well with Fibromyalgia that has established efficacy for improving functional status and reducing pain. |
| Resilience-Enhanced web-based CBT Program | Experimental | Behavioral: Promoting Resilience through Innovative Self-ManagementPatients randomized to PRISM will undergo "Promoting Resilience through Innovative Self-Management" (PRISM) and meet with the MA for an orientation session. The MA describes the program, explains the rationale for treatment, and directs them to the FibroGuide and PRISM websites. Materials and worksheets are provided in the first visit and available online. The e-CBT elements retained are the core elements of CBT for pain, while the resilience-based activities capitalize on the best practices for positive activities interventions including having multiple overlapping activities, making favored activities standard practice beyond the study and having a coaching component. |
| Usual Care | No intervention | –Patients randomized to the usual care only group will have no contact with the study MAs. Usual care patients return for the same follow-up assessments (and electronic medical record review) at 8 weeks and at 6 and 12 months. Whereas major surgery including surgeries for pain, are exclusion criteria, spine and pain injections will be permitted. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary back or spine pain diagnosis from the Back \& Pain Center at University of Michigan.
- High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.
Key exclusion criteria (11 listed)
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
- Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
- Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
- Planned major surgery in the next 12 months;
- Pregnancy or taking steroid medications
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 |
|---|---|---|
| Web-based Cognitive Behavioral Therapy (e-CBT) Self-ManagementAlready noted. | Behavioural | Standard Web-based Cognitive Behavioral Therapy (e-CBT) |
| Promoting Resilience through Innovative Self-ManagementAlso: PRISMAlready noted. | Behavioural | Resilience-Enhanced web-based CBT Program |
Primary outcome
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
Time frame: At 8-week assessment point
The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.
13 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: At 8-week assessment point
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At 8-week assessment point
PROMIS Fatigue-Short Form
Time frame: At 8-week assessment point
Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Time frame: At 8-week assessment point
Subjective well-being
Time frame: At 8-week assessment point
Pain Catastrophizing Scale (PCS)
Time frame: At 8-week assessment point
Patient Health Questionnaire 9-item (PHQ-9):
Time frame: At 8-week assessment point
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: At 8-week assessment point
Perceived Stress Scale (PSS)
Time frame: At 8-week assessment point
Six-Minute Walk Test (6MWT)
Time frame: At 8-week assessment point
Sit-to-Stand Test
Time frame: At 8-week assessment point
Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method
Time frame: At 8-week assessment point
Telomere length
Time frame: At 1 year assessment point
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 18 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management and Promoting Resilience through Innovative Self-Management in people with Chronic Spine Pain and Fibromyalgia, run by University of Michigan 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 2 inclusion and 11 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 18 Nov 2023. 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?
Fibromyalgia Impact Questionnaire-Revised (FIQ-R) (time frame: At 8-week assessment point). 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 18 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.