- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01642810
Online Acceptance-based Behavioural Treatment for Fibromyalgia
30 novembre 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
67
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Centre
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in Fibromyalgia Impact Questionnaire-revised
Lasso di tempo: baseline, 2 months, 5 months
|
Assesses overall impact of Fibromyalgia symptoms on daily functioning
|
baseline, 2 months, 5 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in Center for Epidemiological Studies Depression Scale
Lasso di tempo: Baseline, 2 months, 5 months
|
Evaluation of depressive symptoms
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Chronic Pain Acceptance Questionnaire
Lasso di tempo: Baseline, 2 months, 5 months
|
Overall acceptance of chronic pain
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Cognitive Fusion Questionnaire
Lasso di tempo: Baseline, 2 months, 5 months
|
Evaluation of fusion with thoughts
|
Baseline, 2 months, 5 months
|
|
Change from baseline in McGill Pain Questionnaire- short form
Lasso di tempo: 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
Lasso di tempo: Baseline, 2 months, 5 months
|
Measure of mindfulness skills
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Pittsburgh Sleep Quality Index
Lasso di tempo: 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
Lasso di tempo: Baseline, 2 months, 5 months
|
Measure of fear of movement
|
Baseline, 2 months, 5 months
|
|
Change from baseline in Valued Living Questionnaire
Lasso di tempo: Baseline, 2 months, 5 months
|
Measure of values, and how consistently one lives those values
|
Baseline, 2 months, 5 months
|
|
Global Assessment Scale
Lasso di tempo: 2 months
|
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
|
2 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Heather Simister, MA, University of Manitoba
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2012
Completamento primario (Effettivo)
1 agosto 2014
Completamento dello studio (Effettivo)
1 agosto 2015
Date di iscrizione allo studio
Primo inviato
25 giugno 2012
Primo inviato che soddisfa i criteri di controllo qualità
15 luglio 2012
Primo Inserito (Stima)
17 luglio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
2 dicembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 novembre 2015
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H2012:179
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Will vary per participant
-
The Cleveland ClinicEthicon, Inc.ReclutamentoPancreatoduodenectomia | Procedura WhippleStati Uniti