Back to results

Pain and Stress Management for Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stress and Emotions

Thoughts and Behaviors

Brain and Body

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Behavioral interventions, Psychological interventions

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

University of Michigan Medical Center
Wayne State University
St. John Providence Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Stress and Emotions

Thoughts and Behaviors

Brain and Body

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Brief Pain Inventory

Secondary Outcome Measures

SF-12

PROMIS Fatigue short form

Pittsburgh Sleep Quality Index

Center for Epidemiological Studies - Depression Scale

Generalized Anxiety Disorder - 7

Positive and Negative Affect Schedule

Satisfaction with Life Scale

Multiple Ability Self-Report Questionnaire

Patient Global Assessment of Change

Health Care Utilization Scale

Real-time Physical Activity (Actiwatch)

Heart Rate Variability

Levels of Emotional Awareness Scale

Emotional Expressivity Scale

Ambivalence over Emotional Expression

Toronto Alexithymia Scale-20

Impact of Events Scale - Revised

BBCA - short form

Pain Catastrophizing

Beliefs in Pain Control Questionnaire

Communication Thoughts and Feelings Questionnaire

Experimental (thumb nail pressure) threshold and tolerance ratings

2010 ACR modified clinical criteria for FM, including widespread pain index

Full Information

NCT ID

NCT01287481

First Posted

November 2, 2010

Last Updated

March 15, 2016

Sponsor

Wayne State University

Collaborators

University of Michigan, St. John Providence Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01287481

Brief Title

Pain and Stress Management for Fibromyalgia

Official Title

Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

Collaborators

University of Michigan, St. John Providence Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Behavioral interventions, Psychological interventions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stress and Emotions

Arm Type

Experimental

Arm Description

Arm Title

Thoughts and Behaviors

Arm Type

Active Comparator

Arm Description

Arm Title

Brain and Body

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Stress and Emotions

Intervention Description

Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.

Intervention Type

Behavioral

Intervention Name(s)

Thoughts and Behaviors

Intervention Description

Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.

Intervention Type

Behavioral

Intervention Name(s)

Brain and Body

Intervention Description

Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.

Primary Outcome Measure Information:

Title

Brief Pain Inventory

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Secondary Outcome Measure Information:

Title

SF-12

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

PROMIS Fatigue short form

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Pittsburgh Sleep Quality Index

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Center for Epidemiological Studies - Depression Scale

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Generalized Anxiety Disorder - 7

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Positive and Negative Affect Schedule

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Satisfaction with Life Scale

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Multiple Ability Self-Report Questionnaire

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Patient Global Assessment of Change

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Health Care Utilization Scale

Time Frame

Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Title

Real-time Physical Activity (Actiwatch)

Time Frame