Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
13 décembre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
140
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Stockholm
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Solna, Stockholm, Suède, 17177
- Karolinska Institutet
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 100 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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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.
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Aucune intervention: 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).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in the Fibromyalgia Impact Questionnaire (FIQ)
Délai: Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
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Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Insomnia Severity Index (ISI)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in sleep disturbances from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Fatigue Severity Scale (FSS)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in fatigue from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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WHO Disability Assessment Schedule 2.0 (WHODAS 2)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in level of function from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Brunnsviken Brief Quality of Life Inventory (BBQ)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in quality of life from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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The Psychological Inflexibility in Pain Scale (PIPS)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in covert avoidance from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Pain Reactivity Scale (PRS)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in pain-related fear and negative thoughts from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Patient Health Questionnaire-9 (PHQ-9)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in level of depression from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Generalised Anxiety Disorder 7-item scale (GAD-7)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in level of anxiety from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in reactivity to inner experiences from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in health-care costs and sick-leave from baseline to Week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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EQ5D
Délai: Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Change in health-related quality of life from baseline to week 10, and at 6- and 12 months after treatment has ended.
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Week 0, week 10, follow-up at 6- and 12-months after treatment has ended
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Délai: Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9
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Possible presence of suicidal thoughts or ideation during treatment
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Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2015
Achèvement primaire (Réel)
1 juillet 2016
Achèvement de l'étude (Réel)
1 juillet 2016
Dates d'inscription aux études
Première soumission
17 décembre 2015
Première soumission répondant aux critères de contrôle qualité
19 décembre 2015
Première publication (Estimation)
23 décembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 décembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 décembre 2016
Dernière vérification
1 décembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EPN 2015/1528-31/1
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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