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

13 december 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zweden
    • Stockholm
      • Solna, Stockholm, Zweden, 17177
        • Karolinska Institutet

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 100 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Tijdsspanne: 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]

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Insomnia Severity Index (ISI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2015

Primaire voltooiing (Werkelijk)

1 juli 2016

Studie voltooiing (Werkelijk)

1 juli 2016

Studieregistratiedata

Eerst ingediend

17 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

19 december 2015

Eerst geplaatst (Schatting)

23 december 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

14 december 2016

Laatste update ingediend die voldeed aan QC-criteria

13 december 2016

Laatst geverifieerd

1 december 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EPN 2015/1528-31/1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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