Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia Patients (IDAT26)

April 28, 2026 updated by: Armando Almeida, University of Minho

Between Paws and Affections: Impact of Dog Assisted Therapy on Pain, Emotional Symptoms, and Functioning in Fibromyalgia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Filipa Martins-Alves, Psychiatric Hospital Assistant
  • Phone Number: +351 964770140
  • Email: id12083@alunos.uminho.pt

Study Locations

  • Portugal
      • Guimarães, Portugal, 4835-044
        • Recruiting
        • Unidade Local de Saúde (ULS) Alto Ave
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Soraia Moreira, Psychiatric nurse
        • Sub-Investigator:
          • José Vilaça-da-Costa, PM&R Hospital Assistant
        • Sub-Investigator:
          • Patrícia Araújo, Medical Resident
        • Sub-Investigator:
          • Diogo Costa, Medical Resident
        • Sub-Investigator:
          • Laurinda Lemos, Anaesthesia Senior Consultant
        • Principal Investigator:
          • Armando Almeida, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral: 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: 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.
Active Comparator: Behavioral: Psychoeducation and Relaxation without Dogs (Control)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity (maximum and average) and pain interference
Time Frame: 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.
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Fibromyalgia impact and functional status
Time Frame: 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)
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depressive symptoms
Time Frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
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.
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Pain catastrophizing
Time Frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
(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.
13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

Unidade Local de Saúde do Alto Ave, EPE

Investigators

  • Study Chair: Armando Almeida, Associate Professor, School of Medicine, University of Minho
  • Principal Investigator: Filipa Martins-Alves, Psychiatric Hospital Assistant, Psychiatry Department, Unidade Local de Saúde (ULS) Alto Ave

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REF.19/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data protection in Portugal is very restricted concerning the sharing of patients' personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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