Pain and Stress Management for Fibromyalgia
15 mars 2016 uppdaterad av: Mark A. Lumley, Wayne State University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
230
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48106
- University of Michigan Medical Center
-
Detroit, Michigan, Förenta staterna, 48202
- Wayne State University
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Southfield, Michigan, Förenta staterna, 48075
- St. John Providence Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Stress and Emotions
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.
|
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
|
|
Aktiv komparator: Thoughts and Behaviors
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.
|
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
|
|
Aktiv komparator: Brain and Body
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.
|
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Brief Pain Inventory
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
SF-12
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
PROMIS Fatigue short form
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Pittsburgh Sleep Quality Index
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Center for Epidemiological Studies - Depression Scale
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Generalized Anxiety Disorder - 7
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Positive and Negative Affect Schedule
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Satisfaction with Life Scale
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Multiple Ability Self-Report Questionnaire
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Patient Global Assessment of Change
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Health Care Utilization Scale
Tidsram: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Real-time Physical Activity (Actiwatch)
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Heart Rate Variability
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Levels of Emotional Awareness Scale
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Emotional Expressivity Scale
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Ambivalence over Emotional Expression
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Toronto Alexithymia Scale-20
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Impact of Events Scale - Revised
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
BBCA - short form
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Pain Catastrophizing
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Beliefs in Pain Control Questionnaire
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Communication Thoughts and Feelings Questionnaire
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Experimental (thumb nail pressure) threshold and tolerance ratings
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
2010 ACR modified clinical criteria for FM, including widespread pain index
Tidsram: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mark A Lumley, Ph.D., Wayne State University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2011
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
2 november 2010
Först inskickad som uppfyllde QC-kriterierna
28 januari 2011
Första postat (Uppskatta)
1 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 mars 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R01AR057808 (U.S.S. NIH-anslag/kontrakt)
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