Online Acceptance-based Behavioural Treatment for Fibromyalgia
30 november 2015 uppdaterad av: Heather Simister, University of Manitoba
Online Acceptance-Based Behavioural Treatment for Fibromyalgia
A recent study published by the Canadian Pain Society estimated the direct health care costs of chronic pain to be about 6 billion dollars.
Over 1/3 of all Canadians reported that they either missed work or experienced reduced productivity due to chronic pain.
Fibromyalgia Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom are still in the prime of their lives.
While pain and fatigue are prominent symptoms, FMS sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache, memory and thinking problems, and depression.
Standard treatments focus on medication and physical exercise but are not always successful.
Acceptance-Based behavioural therapy (ABBT) is a relatively new approach that has been effective not only in treating mental health concerns such as anxiety and depression, but also other medical conditions such as diabetes and chronic pain.
A novel ABBT for FMS was developed and pilot tested with a small group of participants.
The results of this preliminary study were promising.
Unfortunately, many people cannot adequately access available treatment due to long wait lists, prohibitive costs, or time/location constraints.
Online treatments may offer improved access to care without reducing the effectiveness of treatment.
Therefore, the ABBT for FMS used in the pilot study is being adapted to an online format and will be evaluated with a larger group of participants.
A wait-list/control group will be employed to evaluate the effectiveness of the online treatment as compared with treatment-as-usual.
If found effective, this treatment would offer patients easier access to care at a significantly reduced cost to the health care system.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The current study extended a pilot study (Shay, Tkachuk, Simister, Bailly, & Skrabek, 2011), modifying the previous treatment to a 6 unit program that could be delivered online.
Sixty-one participants completed the study, being randomly assigned to an online ABBT plus treatment-as-usual (online ABBT + TAU) group or a treatment-as-usual alone (TAU) group.
All participants completed a series of self-report measures at baseline, at post-treatment, and at a 3-month follow-up.
Linear mixed modelling supported significant differences between the groups in favour of the ABBT + TAU treatment group on the primary outcome measure (Fibromyalgia Impact Questionnaire-Revised (FIQ-R); F (2, 52.82) = 20.10,
p < .0001)
following treatment.
The online ABBT + TAU group also had significantly greater improvements in depression, pain, acceptance, perceived helplessness, and kinesiophobia.
Increased acceptance mediated the effects of treatment on improvements in FMS quality of life and FMS impact, while reduced helplessness mediated the effects of treatment on improvements in level of reported pain.
Comments and subjective ratings of improvement were consistent with the quantitative results.
Participants rated mindfulness (contact with present moment experience) as the most useful treatment unit.
Studietyp
Interventionell
Inskrivning (Faktisk)
67
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3A 1R9
- Health Sciences Centre
-
-
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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Participants of either sex aged 18 years and older with a formal diagnosis of FMS will be recruited.
- Individuals younger than 18 years of age will be excluded in order to ensure all participants have reached the age of majority and can provide consent.
- They will have a pain intensity rating of at least 4/10 based on self-report. Participants will also be screened using the Wolfe et al (2010) criteria during the in-person session to ensure they meet criteria for FMS.
- Must reside in and complete study from within Manitoba, Canada
Exclusion Criteria:
- People with co-morbidities such as rheumatologic conditions, other conditions affecting the immune system (e.g. chronic fatigue syndrome, multiple sclerosis, lupus), brain injury, cognitive impairment that would limit a participant's ability to complete informed consent, active psychosis, substance abuse, uncontrolled major depression or bipolar disorder, active suicidality, or those who have current active injury claims will be excluded.
- Given the use of a large amount of reading materials, participants will be asked if they have completed at least grade 9 in high school. Those who have only completed grade 8 or lower will be excluded.
- Further, participants will be asked to maintain their pre-study treatment regime and not making changes to their medications or beginning other treatments for the duration of the study.
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: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Treatment-as-usual
Participants continue their pre-study treatment plan, based on their physician/other professional recommendations
|
Participants will continue pre-study treatment under their current licensed practitioners.
Intervention may include drug treatment, physical therapy, or other
|
|
Experimentell: Online ABBT treatment + TAU
Participants to complete a 6-unit online Acceptance-based behavioural treatment including training in pacing, mindfulness, acceptance, cognitive defusion, willingness, and exercise while also maintaining their pre-study treatment.
|
Participants will continue pre-study treatment under their current licensed practitioners.
Intervention may include drug treatment, physical therapy, or other
Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Fibromyalgia Impact Questionnaire-revised
Tidsram: baseline, 2 months, 5 months
|
Assesses overall impact of Fibromyalgia symptoms on daily functioning
|
baseline, 2 months, 5 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Center for Epidemiological Studies Depression Scale
Tidsram: Baseline, 2 months, 5 months
|
Evaluation of depressive symptoms
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Chronic Pain Acceptance Questionnaire
Tidsram: Baseline, 2 months, 5 months
|
Overall acceptance of chronic pain
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Cognitive Fusion Questionnaire
Tidsram: Baseline, 2 months, 5 months
|
Evaluation of fusion with thoughts
|
Baseline, 2 months, 5 months
|
|
Change from baseline in McGill Pain Questionnaire- short form
Tidsram: Baseline, 2 months, 5 months
|
subjective measure of type and severity of pain
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Five Facet Mindfulness Questionnaire
Tidsram: Baseline, 2 months, 5 months
|
Measure of mindfulness skills
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Pittsburgh Sleep Quality Index
Tidsram: Baseline, 2 months, 5 months
|
Measure of sleep quality and quantity
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Tampa Scale of Kinesiophobia-11
Tidsram: Baseline, 2 months, 5 months
|
Measure of fear of movement
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Valued Living Questionnaire
Tidsram: Baseline, 2 months, 5 months
|
Measure of values, and how consistently one lives those values
|
Baseline, 2 months, 5 months
|
|
Global Assessment Scale
Tidsram: 2 months
|
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
|
2 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Heather Simister, MA, University of Manitoba
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 september 2012
Primärt slutförande (Faktisk)
1 augusti 2014
Avslutad studie (Faktisk)
1 augusti 2015
Studieregistreringsdatum
Först inskickad
25 juni 2012
Först inskickad som uppfyllde QC-kriterierna
15 juli 2012
Första postat (Uppskatta)
17 juli 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H2012:179
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .