Fibromyalgia Clinical Trial
Official title:
Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.
Verified date | December 2016 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 100 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Solna | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S) | 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 | No |
Primary | Change in the Fibromyalgia Impact Questionnaire (FIQ) | 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] | No |
Secondary | Insomnia Severity Index (ISI) | 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 | No |
Secondary | Fatigue Severity Scale (FSS) | 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 | No |
Secondary | WHO Disability Assessment Schedule 2.0 (WHODAS 2) | 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 | No |
Secondary | Brunnsviken Brief Quality of Life Inventory (BBQ) | 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 | No |
Secondary | The Psychological Inflexibility in Pain Scale (PIPS) | 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 | No |
Secondary | Pain Reactivity Scale (PRS) | 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 | No |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | 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 | No |
Secondary | Generalised Anxiety Disorder 7-item scale (GAD-7) | 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 | No |
Secondary | Subscale "reactivity to inner experiences" from Five Facets of Mindfulness Questionnaire (FFMQ) | 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 | No |
Secondary | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | 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 | No |
Secondary | EQ5D | 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 | No |
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