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

13 grudnia 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

140

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Szwecja
    • Stockholm
      • Solna, Stockholm, Szwecja, 17177
        • Karolinska Institutet

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 100 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Brak interwencji: 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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the Fibromyalgia Impact Questionnaire (FIQ)
Ramy czasowe: 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]

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Insomnia Severity Index (ISI)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Karolinska Institutet

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2015

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2016

Ukończenie studiów (Rzeczywisty)

1 lipca 2016

Daty rejestracji na studia

Pierwszy przesłany

17 grudnia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 grudnia 2015

Pierwszy wysłany (Oszacować)

23 grudnia 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

14 grudnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 grudnia 2016

Ostatnia weryfikacja

1 grudnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EPN 2015/1528-31/1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

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