Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322485
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2024-03-14
Brief Title:
Online Self-management in Fibromyalgia
Sponsor:
Leiden University
Organization:
Leiden University Medical Center
Study Overview
Official Title:
An Online Self-management Intervention for Patients With Hand Fibromyalgia - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study has been previously registered with the National Trial Registry NTR6267 that has been cancelled The registered trial has been automatically transferred to a new Landelijk Trial Register which does not contain all correct information on the current study and where no corrections can be made Hence the current study has been registered again with ClinicalTrialsgov
The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia A randomized controlled trial RCT will be performed in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group ie after 6 months The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured
The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia A randomized controlled trial RCT will be performed in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group ie after 6 months The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured
Detailed Description:
Rationale Fibromyalgia has a high clinical burden with patients experiencing considerable pain physical disability and an often decreased health-related quality of life HR-QoL Improving patients skills in managing a chronic condition self-management is increasingly recognized as vital in the treatment of somatic conditions and is becoming more common in clinical practice and research In this study the effectiveness of an internet-based self-management intervention focusing on coping skills related to chronic pain compared with a waitlist control condition is studied
Objective To study the effectiveness of the internet-based self-management intervention in patients with fibromyalgia
Study design An RCT will be performed in which 70 patients will be randomized to either the internet-based self-management intervention or a waitlist control group Baseline post-intervention 6-week and three-month follow-up questionnaires will be used to measure primary and secondary outcomes
Study population Patients 18 years diagnosed with fibromyalgia confirmed by their general practitioner or a medical specialist who visit the Fibrocentrum a fibromyalgia treatment centre in Leiden The Netherlands will be invited to participate in the study Patients need to have a pain duration of a minimum of 3 months be fluent in Dutch be able to give informed consent and own a computer with internet access Difficulties with written communication and internet literacy severe physical and psychiatric comorbidities that interfere with the study protocol eg addiction psychosis and suicidal ideation pregnancy on-going psychological treatment elsewhere and participation in other clinical trials are exclusion criteria
Intervention The cognitive-behavioral intervention begins with a face-to-face intake session in which personal goals for the intervention are set Afterwards the tailored self-management intervention consisting of 6 modules will be offered via an internet-based program The first introductory module includes goal-setting and the last module includes relapse prevention the four modules in between focus on learning how to cope with the consequences of a chronic condition in daily life The topics of the modules are 1 activity 2 mood 3 thoughts and 4 the social environment At least once a week a psychologist provides participants with feedback and motivational support through messages in a secured mail box in the internet-based program After finishing the internet-based intervention two booster sessions will take place via telephone 1 month and 25 months after the program Patients will be called by their psychologist and their goals will be evaluated and strategies to strengthen the achieved results will be discussed
Main study parametersendpoints The primary effect will be determined by comparing the VAS pain coping scores after the intervention between the waitlist control group and intervention group corrected for baseline VAS pain coping scores As secondary outcomes several other psychological and physical outcomes will be measured eg HR-QoL pain cognitions pain impact on daily life well-being as well as quality of the therapeutic relationship and cost-effectiveness of the intervention
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the waitlist control condition patients will receive the intervention after the intervention ends in the intervention group after 6 months In the intervention group patients will be offered an internet-based self-management intervention which could improve their pain coping and other psychological and physical outcomes No risk is involved with participation in this study The only burden for participants is time investment
Objective To study the effectiveness of the internet-based self-management intervention in patients with fibromyalgia
Study design An RCT will be performed in which 70 patients will be randomized to either the internet-based self-management intervention or a waitlist control group Baseline post-intervention 6-week and three-month follow-up questionnaires will be used to measure primary and secondary outcomes
Study population Patients 18 years diagnosed with fibromyalgia confirmed by their general practitioner or a medical specialist who visit the Fibrocentrum a fibromyalgia treatment centre in Leiden The Netherlands will be invited to participate in the study Patients need to have a pain duration of a minimum of 3 months be fluent in Dutch be able to give informed consent and own a computer with internet access Difficulties with written communication and internet literacy severe physical and psychiatric comorbidities that interfere with the study protocol eg addiction psychosis and suicidal ideation pregnancy on-going psychological treatment elsewhere and participation in other clinical trials are exclusion criteria
Intervention The cognitive-behavioral intervention begins with a face-to-face intake session in which personal goals for the intervention are set Afterwards the tailored self-management intervention consisting of 6 modules will be offered via an internet-based program The first introductory module includes goal-setting and the last module includes relapse prevention the four modules in between focus on learning how to cope with the consequences of a chronic condition in daily life The topics of the modules are 1 activity 2 mood 3 thoughts and 4 the social environment At least once a week a psychologist provides participants with feedback and motivational support through messages in a secured mail box in the internet-based program After finishing the internet-based intervention two booster sessions will take place via telephone 1 month and 25 months after the program Patients will be called by their psychologist and their goals will be evaluated and strategies to strengthen the achieved results will be discussed
Main study parametersendpoints The primary effect will be determined by comparing the VAS pain coping scores after the intervention between the waitlist control group and intervention group corrected for baseline VAS pain coping scores As secondary outcomes several other psychological and physical outcomes will be measured eg HR-QoL pain cognitions pain impact on daily life well-being as well as quality of the therapeutic relationship and cost-effectiveness of the intervention
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the waitlist control condition patients will receive the intervention after the intervention ends in the intervention group after 6 months In the intervention group patients will be offered an internet-based self-management intervention which could improve their pain coping and other psychological and physical outcomes No risk is involved with participation in this study The only burden for participants is time investment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None