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

13 december 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

140

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Tidsram: 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]

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Insomnia Severity Index (ISI)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Karolinska Institutet

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2015

Primärt slutförande (Faktisk)

1 juli 2016

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

17 december 2015

Först inskickad som uppfyllde QC-kriterierna

19 december 2015

Första postat (Uppskatta)

23 december 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 december 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 december 2016

Senast verifierad

1 december 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EPN 2015/1528-31/1

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

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