Resilience Skills Self-Management for Chronic Pain.

November 15, 2023 updated by: Afton Hassett, Psy.D., University of Michigan
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Back & Pain Center, University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Web-based Cognitive Behavioral Therapy (e-CBT)
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.
Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management
Already noted.
Experimental: Resilience-Enhanced web-based CBT Program
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.
Behavioral: Promoting Resilience through Innovative Self-Management
Already noted.
Other Names:
  • PRISM
No Intervention: Usual Care
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 8-week assessment point

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
PROMIS Fatigue-Short Form
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Subjective well-being
Time Frame: At 8-week assessment point
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).
At 8-week assessment point
Pain Catastrophizing Scale (PCS)
Time Frame: At 8-week assessment point
. 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.
At 8-week assessment point
Patient Health Questionnaire 9-item (PHQ-9):
Time Frame: At 8-week assessment point
The PHQ-9 is a 9-item multipurpose instrument that has utility for screening, diagnosing, monitoring, and measuring the severity of depression.
At 8-week assessment point
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Perceived Stress Scale (PSS)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Six-Minute Walk Test (6MWT)
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Sit-to-Stand Test
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method
Time Frame: At 8-week assessment point
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.
At 8-week assessment point
Telomere length
Time Frame: At 1 year assessment point
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).
At 1 year assessment point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00124722
  • 5R01NR017096-05 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

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