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

13. Dezember 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

140

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
    • Stockholm
      • Solna, Stockholm, Schweden, 17177
        • Karolinska Institutet

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Kein Eingriff: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Zeitfenster: 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]

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Insomnia Severity Index (ISI)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karolinska Institutet

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2015

Primärer Abschluss (Tatsächlich)

1. Juli 2016

Studienabschluss (Tatsächlich)

1. Juli 2016

Studienanmeldedaten

Zuerst eingereicht

17. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Dezember 2015

Zuerst gepostet (Schätzen)

23. Dezember 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

14. Dezember 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Dezember 2016

Zuletzt verifiziert

1. Dezember 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EPN 2015/1528-31/1

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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