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Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.

13. december 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
    • Stockholm
      • Solna, Stockholm, Sverige, 17177
        • Karolinska Institutet

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Internet-based exposure therapy
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.
Ingen indgriben: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Tidsramme: 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]

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia Severity Index (ISI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2015

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

17. december 2015

Først indsendt, der opfyldte QC-kriterier

19. december 2015

Først opslået (Skøn)

23. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EPN 2015/1528-31/1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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