Psychologically Informed Telerehabilitation for Fibromyalgia

Condition(s) studied

Investigational drug(s) / intervention(s)

Online Psychologically-Informed Physical Therapy: 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

Paper-based booklet: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Recruitment Feasibility — Throughout the recruitment period.
  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.
• Consent Rate Among Eligible Participants — At screening/enrollment.
  Proportion of eligible participants who provide informed consent to participate in the study. Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
• Participant Retention Rate — At 3 months
  Proportion of randomized participants who complete the primary feasibility assessment time point (T1). Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
• Adherence to PIPT Sessions — Throughout the 12-month intervention period.
  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%.
• Completeness of Secondary Outcome Data — At 3 months
  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%.
• Treatment Acceptability and Preferences (TAP) Score — Following the intervention/at the prespecified acceptability assessment point.
  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.
• Incidence of Intervention-Related Adverse Events and Serious Adverse Events — From enrollment through the final telerehabilitation session, up to 12 months.
  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.
• Control Group Contamination Rate — Throughout the study period, up to 12 months.
  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%.
• Successful Completion of Videoconference Sessions — Throughout the 12-month intervention period.
  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%.
• Criteria for a definitive RCT — At the end of the intervention
  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

Trial sites (1)

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