Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
tiistai 13. joulukuuta 2016 päivittänyt: Erik Andersson, Karolinska Institutet
The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e) depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any variables could moderate/mediate the treatment outcome, such as a) degree of covert avoidance, b) degree of reactivity to inner sensations
Trial Design: Randomized controlled trial with waitlist control, who also will receive treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long term follow-up is also investigated (potential changes from post-treatment to 6- and 12 months after treatment completion)
Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)
Description of Trial Subjects: Patients > 18 years old, Fibromyalgia diagnosis, residing in Sweden.
Number of Subjects: 140
Sample size estimation: Sample size is based on a estimated effect size (measured by Cohen's d) of 0.5, based on a power of 0.8 and with room for a 10 % dropout rate.
Recruitment: Self-referral. Advertising will be made through national newspaper, social media and on patient organisations' websites.
Safety parameters: Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.
Data collection: Data will be collected electronically via the treatment platform.
Plan for missing data: Last-observation carried forward (LOCF).
Main statistical analysis: Hierarchical linear mixed modelling.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
140
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Stockholm
-
Solna, Stockholm, Ruotsi, 17177
- Karolinska Institutet
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 100 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Fibromyalgia diagnosis
- Swedish resident
- Internet connection before, under and after treatment
- Willing to refrain from other concurrent psychological treatment during the study
- Agreement to keep psychotrophic medication constant during the study
Exclusion Criteria:
- Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
- Ongoing alcohol or substance abuse
- Psychosis
- Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; >29 weeks gestation
- Illiteracy or poor skills in Swedish language
- Insufficient computer or language skills to manage a text-based treatment.
- Other concurrent psychological treatment
- Recent changes in psychotrophic medication (<6 weeks prior to randomization)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Internet-based exposure therapy
The experimental group will go through active internet-based treatment which is delivered on a safe internet platform.
Treatment is divided into eight modules, each containing homework assignments.
Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.
|
The treatment is a 10 week long cognitive behavior therapy.
It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure.
|
|
Ei väliintuloa: Waitlist
Waitlist control, i.e. no active active intervention during waiting list period.
Will be offered treatment when the first group has finished (i.e.
week 10).
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Aikaikkuna: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
|
Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Insomnia Severity Index (ISI)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in sleep disturbances from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Fatigue Severity Scale (FSS)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in fatigue from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS 2)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in level of function from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Brunnsviken Brief Quality of Life Inventory (BBQ)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in quality of life from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
The Psychological Inflexibility in Pain Scale (PIPS)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in covert avoidance from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Pain Reactivity Scale (PRS)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in pain-related fear and negative thoughts from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Patient Health Questionnaire-9 (PHQ-9)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in level of depression from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Generalised Anxiety Disorder 7-item scale (GAD-7)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in level of anxiety from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in reactivity to inner experiences from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in health-care costs and sick-leave from baseline to Week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
|
EQ5D
Aikaikkuna: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Change in health-related quality of life from baseline to week 10, and at 6- and 12 months after treatment has ended.
|
Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Aikaikkuna: Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9
|
Possible presence of suicidal thoughts or ideation during treatment
|
Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. joulukuuta 2015
Ensisijainen valmistuminen (Todellinen)
Perjantai 1. heinäkuuta 2016
Opintojen valmistuminen (Todellinen)
Perjantai 1. heinäkuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 17. joulukuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Lauantai 19. joulukuuta 2015
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 23. joulukuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 14. joulukuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 13. joulukuuta 2016
Viimeksi vahvistettu
Torstai 1. joulukuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- EPN 2015/1528-31/1
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
PÄÄTTÄMÄTÖN
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .