An interventional study of Online Psychologically-Informed Physical Therapy and Paper-based booklet in Fibromyalgia, sponsored by IRCCS San Raffaele Roma. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Treatment
Fibromyalgia is a long-term condition that can cause widespread pain, fatigue, sleep problems, difficulties with concentration, and limitations in daily activities. Physical, psychological, and social factors can all influence how people experience and manage these symptoms.
This study will examine whether an online Psychologically-Informed Physical Therapy (PIPT) program is feasible, acceptable, and safe for adults with fibromyalgia. PIPT is a physiotherapy approach that combines physical rehabilitation with attention to factors such as fear of movement, unhelpful beliefs about pain, coping strategies, and confidence in returning to meaningful activities. It is not intended to treat mental health disorders. Instead, the physiotherapist supports participants in understanding their pain, identifying personal goals, gradually increasing activity, and developing strategies to better manage their condition.
This is a pilot randomized controlled trial involving approximately 32 adults aged 18 to 65 years with fibromyalgia. Participants will be randomly assigned to one of two groups.
Participants in the PIPT group will receive an individualized program delivered remotely by videoconference. The program will include 12 sessions, with up to 3 additional optional sessions, over a period of 12 months. Most sessions will take place during the first 3 months. Sessions will include education about chronic pain, collaborative goal setting, discussion of barriers to activity, support for gradual physical reactivation, and development of self-management strategies.
Participants in the comparison group will receive an educational booklet about pain neuroscience and a program of exercises to perform three times per week during the first 3 months. They will also receive scheduled telephone calls to monitor adherence and their clinical progress.
The main purpose of this pilot study is not to determine definitively whether PIPT is better than the comparison program. Instead, the researchers will assess whether a larger clinical trial can be successfully conducted. They will examine recruitment, retention, attendance, completeness of study data, delivery of the intervention as planned, participant acceptability, technical problems during online sessions, and any adverse events.
The study will also collect preliminary information about possible changes in fibromyalgia impact, physical function, quality of life, anxiety and depression, fear of movement, fear-avoidance beliefs, and physical performance. Brain activity will also be explored using electroencephalography (EEG).
Participants receiving PIPT will additionally be invited to take part in interviews about their experiences with the program. These interviews will help researchers understand what participants found helpful or difficult, what may encourage or prevent engagement, and how the program could be improved.
The results will be used to refine the intervention and study procedures and to determine whether a larger, fully powered randomized controlled trial of online PIPT for fibromyalgia should be undertaken.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →IRCCS San Raffaele Roma is the lead sponsor of 64 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Participants allocated to the experimental arm will receive an individualized Psychologically-Informed Physical Therapy (PIPT) program delivered entirely remotely via Zoom. PIPT integrates physical rehabilitation with the identification and management of psychological and social factors that may influence pain, disability, and functional recovery, such as fear of movement, unhelpful beliefs, catastrophizing, and ineffective coping strategies. The intervention does not aim to treat primary psychological disorders, but to support participants in overcoming psychosocial barriers to physical reactivation and self-management. The program will consist of 12 sessions, with up to 3 additional optional sessions, delivered over 12 months. The first session will last approximately 60-75 minutes, and subsequent sessions approximately 30-45 minutes. Eight sessions will be delivered during the first 3 months, while the remaining sessions will be scheduled over the following 9 months according to i
Behavioral: Online Psychologically-Informed Physical Therapy
Participants allocated to the control group will receive a paper-based informational booklet on Cognitive Behavioral Therapy together with a home exercise program to be performed three times per week during the first 3 months. During this initial 3-month period, participants will receive a weekly telephone call from a physiotherapist to monitor adherence to the prescribed exercises. Additional follow-up telephone calls will be conducted at 6 and 9 months after enrollment to monitor the progression of the participant's condition. These follow-up contacts will not include additional patient education or therapeutic interaction intended to reproduce components of the PIPT intervention.
Behavioral: Paper-based booklet
The intervention consists of an individualized Psychologically-Informed Physical Therapy (PIPT) program delivered entirely remotely via Zoom. PIPT integrates physical rehabilitation with the identification and management of psychological and social factors that may influence pain perception, disability, and functional recovery, including fear of movement, dysfunctional beliefs, catastrophizing, and ineffective coping strategies. The intervention is not intended to treat primary psychological disorders; rather, it aims to help participants overcome psychosocial barriers to physical reactivation and develop effective self-management strategies. The program includes 12 scheduled sessions, with up to 3 additional optional sessions, delivered over 12 months. The first session lasts approximately 60-75 minutes, while subsequent sessions last approximately 30-45 minutes. Eight sessions are delivered during the first 3 months, with the remaining sessions scheduled over the following 9 months
The control intervention consists of a paper-based Cognitive Behavioral Therapy booklet combined with a home exercise program. Participants will be instructed to perform the prescribed exercises three times per week during the first 3 months of the study. During this period, participants will receive a weekly telephone call from a physiotherapist to monitor adherence to the exercise program. These calls will be limited to adherence monitoring and will not include additional education, coaching, or therapeutic interaction aimed at reproducing components of the PIPT intervention. After the initial 3-month period, participants will receive additional follow-up telephone calls at 6 and 9 months after enrollment to monitor the progression of their condition. These contacts will likewise avoid patient education or therapeutic interaction intended to generate effects related to the therapeutic encounter.
Recruitment Feasibility
Monthly enrollment rate and proportion of eligible individuals who enroll in the study. Recruitment feasibility will be evaluated according to prespecified traffic-light progression criteria: green, ≥75% of eligible individuals enrolled or ≥10 participants/month; amber, 50-74% or 5-7 participants/month; red, \<50% or \< 5 participant/month.
Time frame: Throughout the recruitment period.
Consent Rate Among Eligible Participants
Proportion of eligible participants who provide informed consent to participate in the study. Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
Time frame: At screening/enrollment.
Participant Retention Rate
Proportion of randomized participants who complete the primary feasibility assessment time point (T1). Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
Time frame: At 3 months
Adherence to PIPT Sessions
Proportion of planned Psychologically-Informed Physical Therapy sessions completed by participants allocated to the intervention group. Prespecified progression criteria are: green, median adherence ≥70%; amber, 50-69%; red, \<50%.
Time frame: Throughout the 12-month intervention period.
Completeness of Secondary Outcome Data
Proportion of participants with complete datasets for the prespecified secondary outcomes at the primary feasibility time point. Prespecified progression criteria are: green, ≥90%; amber, 75-89%; red, \<75%.
Time frame: At 3 months
Treatment Acceptability and Preferences (TAP) Score
Acceptability of the intervention will be assessed using the Treatment Acceptability and Preferences (TAP) measure, supplemented by brief exit interviews evaluating perceived value, burden, and usability of the telerehabilitation pathway. Higher TAP scores indicate greater treatment acceptability. Prespecified progression criteria are based on TAP scores, with scores ≥12 indicating the green progression category and scores \<8 indicating the red category.
Time frame: Following the intervention/at the prespecified acceptability assessment point.
Incidence of Intervention-Related Adverse Events and Serious Adverse Events
Number and proportion of participants experiencing adverse events (AEs) or serious adverse events (SAEs) considered related to the intervention. Events will be documented for severity, causality, actions taken, outcome, and follow-up. Prespecified progression criteria consider both the occurrence of SAEs and the proportion of participants experiencing mild or moderate AEs.
Time frame: From enrollment through the final telerehabilitation session, up to 12 months.
Control Group Contamination Rate
Proportion of control-group participants reporting exposure to components similar to the PIPT intervention during the study. Prespecified progression criteria are: green, ≤10%; amber, 11-20%; red, \>20%.
Time frame: Throughout the study period, up to 12 months.
Successful Completion of Videoconference Sessions
Proportion of scheduled videoconference sessions completed without a technical interruption or dropout lasting more than 5 minutes. Prespecified progression criteria are: green, ≥90%; amber, 80-89%; red, \<80%.
Time frame: Throughout the 12-month intervention period.
Criteria for a definitive RCT
Consistent with the traffic light framework proposed by Avery et al., progression to a definitive RCT will be decided as follows: proceed (green) if ≥6 domains meet green thresholds and no domain is red; amend (amber) if ≤2 domains are red or if 3-5 domains are green; stop (red) if ≥3 domains are red or if a serious adverse event probably related to the intervention occurs alongside an unfavorable safety pattern
Time frame: At the end of the intervention
Revised Fibromyalgia Impact Questionnaire (FIQR)
21-item questionnaire assessing function, overall impact, and symptoms related to fibromyalgia. Total score ranges from 0 to 100, with higher scores indicating greater fibromyalgia impact.
Time frame: At 3 and 12 months
Patient-Specific Functional Scale (PSFS)
Participants identify up to five activities they have difficulty performing and rate each from 0 ("unable to perform") to 10 ("able to perform at premorbid level"). The mean score represents patient-specific functional ability; higher scores indicate better function.
Time frame: At 3 and 12 months
SF-12 Physical Component Summary (PCS)
Physical health component derived from the 12-Item Short Form Health Survey. Scores are transformed to norm-based values; higher scores indicate better physical health-related quality of life.
Time frame: At 3 and 12 months
SF-12 Mental Component Summary (MCS)
Mental health component derived from the 12-Item Short Form Health Survey. Higher scores indicate better mental health-related quality of life.
Time frame: At 3 and 12 months
HADS - Anxiety Subscale
Seven-item Hospital Anxiety and Depression Scale anxiety subscale, ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Time frame: At 3 and 12 months
HADS - Depression Subscale
Seven-item Hospital Anxiety and Depression Scale depression subscale, ranging from 0 to 21. Higher scores indicate greater depressive symptoms.
Time frame: At 3 and 12 months
Tampa Scale of Kinesiophobia (TSK)
17-item measure of pain-related fear of movement or reinjury, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.
Time frame: At 3 and 12 months
Fear-Avoidance Beliefs Questionnaire - Physical Activity Subscale (FABQ-PA)
Subscale assessing fear-avoidance beliefs regarding physical activity, ranging from 0 to 24. Higher scores indicate stronger fear-avoidance beliefs.
Time frame: At 3 and 12 months
Fear-Avoidance Beliefs Questionnaire - Work Subscale (FABQ-W)
Subscale assessing fear-avoidance beliefs regarding work, ranging from 0 to 42. Higher scores indicate stronger fear-avoidance beliefs.
Time frame: At 3 and 12 months
30-Second Sit-to-Stand Test
Number of complete sit-to-stand repetitions performed from a standard chair within 30 seconds. A higher number of repetitions indicates better lower-limb functional performance.
Time frame: At 3 months
Change from baseline in resting-state EEG microstate mean duration
Microstate mean duration will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Mean duration is defined as the average length of uninterrupted episodes assigned to a given microstate class, expressed in milliseconds. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention value minus the baseline value.
Time frame: At 3 months
Change from baseline in resting-state EEG microstate occurrence rate
Microstate occurrence rate will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Occurrence rate is defined as the number of distinct episodes of a given microstate class per second of analyzed EEG, expressed as occurrences per second. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention value minus the baseline value.
Time frame: At 3 months
Change from baseline in resting-state EEG microstate time coverage
Microstate time coverage will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Time coverage is defined as the percentage of the total analyzed EEG recording time assigned to a given microstate class. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention percentage minus the baseline percentage and expressed in percentage points.
Time frame: At 3 months
Plan to share: No — The availability of individual participant data (IPD) has not yet been determined. Given the small sample size of this pilot trial and the inclusion of qualitative interview data, particular attention will be given to protecting participant confidentiality and minimizing the risk of re-identification. Any future sharing of de-identified quantitative IPD will be subject to applicable ethical approvals, participant consent, and data protection regulations. Analysis scripts will be made openly available to support transparency and reproducibility.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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