An interventional study of Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") and Behavioral: Psychoeducation and Relaxation without Dogs (Control) in Fibromyalgia (FM), sponsored by University of Minho. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Minho · Not applicable, Interventional, and Treatment
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).
This is a prospective, non-randomized clinical trial with a control group, conducted at the Day Hospital of the Psychiatry and Mental Health Department of ULS Alto Ave, as an academic research project within a PhD in Medicine at the University of Minho.
The original pilot trial (Ref. 19/2024), including 34 women with FM, showed statistically significant improvements in maximum and average pain intensity, pain interference, total pain catastrophizing and its subscales (helplessness, magnification, rumination), anxiety (HADS) and functional impact (FIQ-P). However, depressive symptoms showed only a non-significant trend for improvement. Critically, analysis of 6-month follow-up data (T3) revealed partial erosion of the initial gains: pain intensity, pain interference, functional impact, and emotional symptoms showed variable maintenance patterns, with particular vulnerability to relapse in depressive symptoms, supporting the need for a prolonged intervention with maintenance sessions to consolidate gains and prevent deterioration over time.
The prolongation protocol comprises: (1) continuation of the initial control group with five monthly relaxation sessions; and (2) inclusion of a new intervention group receiving 10 DAT sessions (4 weekly structured dog-assisted therapy sessions plus 6 monthly guided-relaxation "booster" sessions with dogs) and a new active control group receiving an identical psychoeducational and relaxation program without dogs.
Sessions are group-based (up to 5 patients), last 60 minutes, and are delivered in a dedicated therapy room in the Psychiatry Day Hospital, by a multidisciplinary team (psychiatrist, psychologist, nurse, physiatrist) together with trained therapy dogs (Ari, Maica) and a professional dog handler, with appropriate veterinary follow-up and liability/health insurance.
Eligibility is assessed by a psychiatrist according to predefined inclusion and exclusion criteria; eligible patients provide written informed consent and complete baseline questionnaires (T1) up to four weeks before starting the intervention. Outcome assessments are performed immediately after session 4 (T2), at 6 months after session 4, and before session 10 (T3), and at 12 months after the end of the intervention (T4), in order to monitor the short-term response, the 6-month maintenance or progression of gains, and the 12-month trajectory associated with the monthly booster sessions. All procedures follow the previously approved protocol (Ref. 19/2024) and comply with the requirements of the institutional Ethics Committee and the Data Protection Officer, with no new data categories or processing purposes, and an addendum specifically for the extension of the study has been submitted and approved.
Exclusion Criteria:
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: Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")
New active 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.
Behavioral: Behavioral: Psychoeducation and Relaxation without Dogs (Control)
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.
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.
Pain intensity (maximum and average) and pain interference
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.
Time frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Fibromyalgia impact and functional status
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)
Time frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Anxiety and depressive symptoms
Measured by the Hospital Anxiety and Depression Scale - Anxiety (HADS A, Portuguese version) and Depression (HADS D, Portuguese version) subscales, at T2, T3 and T4.
Time frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Pain catastrophizing
(total score and subscales: helplessness, magnification, rumination), assessed by the Portuguese version of the Pain Catastrophizing Scale, at T2, T3 and T4, to explore whether reductions observed after 1 month of intervention (T2) are sustained or enhanced at 6 (T3) and 12 (T4) months.
Time frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Plan to share: No — Data protection in Portugal is very restricted concerning the sharing of patients' personal data.
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