Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
13 de diciembre de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
140
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Stockholm
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Solna, Stockholm, Suecia, 17177
- Karolinska Institutet
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 100 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Fibromyalgia Impact Questionnaire (FIQ)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insomnia Severity Index (ISI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2015
Finalización primaria (Actual)
1 de julio de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
17 de diciembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de diciembre de 2015
Publicado por primera vez (Estimar)
23 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
13 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EPN 2015/1528-31/1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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