Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")Behavioral: Psychoeducation and Relaxation without Dogs (Control)
Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections"): Dog Assisted Therapy (DAT - "Between Paws and Affections") - Intervention group that will receive a total of 10 group sessions at the Psychiatry Day Hospital of ULS Alto Ave, organized into 4 weekly structured sessions (combining psychoeducation on fibromyalgia and chronic pain, functional training and self care, lifestyle counseling and guided relaxation, all mediated by trained therapy dogs and a professional dog handler), followed by 6 monthly guided relaxation "booster" sessions with the dogs.
Behavioral: Psychoeducation and Relaxation without Dogs (Control): Control group that will receive the same 10 session program, with structure, duration and content identical to the DAT arm (4 weekly structured psychoeducation and functional/self care sessions plus 6 monthly guided relaxation "booster" sessions), but delivered entirely without dogs.
Study summary
The purpose of this study is to evaluate the effectiveness and medium-term maintenance of a structured dog-assisted therapy (DAT) protocol, "Entre Patas e Afetos" (Between Paws and Affections), in reducing pain, anxiety and depressive symptoms and in improving functional status and quality of life in Portuguese patients with fibromyalgia (FM) followed at ULS Alto Ave, with systematic outcome assessment in the immediate post intervention phase (T2), 6-month follow-up (T3) and 12-month follow-up (T4).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older
* Confirmed diagnosis of fibromyalgia
* Being followed at ULS Alto Ave by the Multidisciplinary Pain Unit, Internal Medicine (Auto immune diseases), Physical and Rehabilitation Medicine or Neurology
* Ability to read and write Portuguese and to understand the study procedures
* Willingness and ability to participate voluntarily in the 10 session program and all scheduled assessments (T1-T4)
* Provision of written informed consent
Exclusion Criteria:
* Allergy to dogs or marked fear of dogs
* History of aggression towards animals
* History of oncological disease
* Concomitant systemic or rheumatologic disease that may confound pain and functional assessment
* Decompensated psychiatric disorder or severe cognitive impairment that may compromise comprehension of the protocol or adherence to the intervention
* Refusal to participate or withdrawal of consent at any point
Primary outcome measure(s)
Pain intensity (maximum and average) and pain interference — 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month Measured by the Portuguese Brief Pain Inventory - Short Form , at T2 (post session 4), T3 (6 month follow up) and T4 (12 month follow up), to capture both short term change and medium term maintenance at 6 and 12 months after the first month (T2). Self reported pain intensity using a Numeric Rating Scale with faces / adapted Wong Baker Faces Pain Scale, collected at each session to monitor pain fluctuations across the acute and maintenance phases.
Fibromyalgia impact and functional status — 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month Measured by the Portuguese Fibromyalgia Impact Questionnaire (FIQ P), at T2, T3 and T4, allowing evaluation of functional changes and their persistence at 6 and 12 months after the first month (T2)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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