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

NCT07356206 | Recruiting

• 1 other identifier: REF.19/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fibromyalgia (FM)

Keywords

Fibromyalgia; Dog-Assisted Therapy; Pain; Anxiety; Depression; Psychoeducation and Relaxation; Fuctional Impact; Catastrophizing; follow-up evaluations; Hospital Anxiety and Depression Scale (HADS); Pain Catastrophizing Scale; Portuguese Fibromyalgia Impact Questionnaire (FIQ P); Numerical Rating Scale (NRS); adapted Wong Baker Faces Pain Scale; Portuguese Brief Pain Inventory - Short Form

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Secondary Outcomes (2)

• Anxiety and depressive symptoms

  13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

• Pain catastrophizing

  13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month

Study Arms (2)

Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")

EXPERIMENTAL

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")

Behavioral: Psychoeducation and Relaxation without Dogs (Control)

ACTIVE COMPARATOR

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)

Interventions

Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") 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: Dog Assisted Therapy (DAT - "Between Paws and Affections")

Behavioral: Psychoeducation and Relaxation without Dogs (Control) BEHAVIORAL

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: Psychoeducation and Relaxation without Dogs (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead
• Unidade Local de Saúde do Alto Ave, EPE: collaborator

Study Sites (1)

Unidade Local de Saúde (ULS) Alto Ave

Guimarães, 4835-044, Portugal

RECRUITING

Related Publications (14)

• Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21.

  PMID: 23170993 BACKGROUND

• Clark SD, Martin F, McGowan RTS, Smidt JM, Anderson R, Wang L, Turpin T, Langenfeld-McCoy N, Bauer BA, Mohabbat AB. Physiological State of Therapy Dogs during Animal-Assisted Activities in an Outpatient Setting. Animals (Basel). 2020 May 9;10(5):819. doi: 10.3390/ani10050819.

  PMID: 32397366 BACKGROUND

• Kunzi P, Ackert M, Grosse Holtforth M, Hund-Georgiadis M, Hediger K. Effects of animal-assisted psychotherapy incorporating mindfulness and self-compassion in neurorehabilitation: a randomized controlled feasibility trial. Sci Rep. 2022 Jun 28;12(1):10898. doi: 10.1038/s41598-022-14584-1.

  PMID: 35764668 BACKGROUND

• Kang JH, Choi SE, Park DJ, Lee SS. Disentangling Diagnosis and Management of Fibromyalgia. J Rheum Dis. 2022 Jan 1;29(1):4-13. doi: 10.4078/jrd.2022.29.1.4.

  PMID: 37476701 BACKGROUND

• Petersson M, Uvnas-Moberg K, Nilsson A, Gustafson LL, Hydbring-Sandberg E, Handlin L. Oxytocin and Cortisol Levels in Dog Owners and Their Dogs Are Associated with Behavioral Patterns: An Exploratory Study. Front Psychol. 2017 Oct 13;8:1796. doi: 10.3389/fpsyg.2017.01796. eCollection 2017.

  PMID: 29081760 BACKGROUND

• Beetz A, Uvnas-Moberg K, Julius H, Kotrschal K. Psychosocial and psychophysiological effects of human-animal interactions: the possible role of oxytocin. Front Psychol. 2012 Jul 9;3:234. doi: 10.3389/fpsyg.2012.00234. eCollection 2012.

  PMID: 22866043 BACKGROUND

• Rosado Mda L, Pereira JP, da Fonseca JP, Branco JC. [Cultural adaptation and validation of the "Fibromyalgia Impact Questionnaire"--Portuguese version]. Acta Reumatol Port. 2006 Apr-Jun;31(2):157-65. Portuguese.

  PMID: 17058362 BACKGROUND

• Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.

  PMID: 17365902 BACKGROUND

• Pandey RP, Himanshu; Gunjan; Mukherjee R, Chang CM. The Role of Animal-Assisted Therapy in Enhancing Patients' Well-Being: Systematic Study of the Qualitative and Quantitative Evidence. JMIRx Med. 2024 Mar 18;5:e51787. doi: 10.2196/51787.

  PMID: 38606668 BACKGROUND

• Renner F, DeRubeis R, Arntz A, Peeters F, Lobbestael J, Huibers MJH. Exploring mechanisms of change in schema therapy for chronic depression. J Behav Ther Exp Psychiatry. 2018 Mar;58:97-105. doi: 10.1016/j.jbtep.2017.10.002. Epub 2017 Oct 6.

  PMID: 29035800 BACKGROUND

• Malogiannis IA, Arntz A, Spyropoulou A, Tsartsara E, Aggeli A, Karveli S, Vlavianou M, Pehlivanidis A, Papadimitriou GN, Zervas I. Schema therapy for patients with chronic depression: a single case series study. J Behav Ther Exp Psychiatry. 2014 Sep;45(3):319-29. doi: 10.1016/j.jbtep.2014.02.003. Epub 2014 Feb 24.

  PMID: 24650608 BACKGROUND

• Clark S, Martin F, McGowan RTS, Smidt J, Anderson R, Wang L, Turpin T, Langenfeld-McCoy N, Bauer B, Mohabbat AB. The Impact of a 20-Minute Animal-Assisted Activity Session on the Physiological and Emotional States in Patients With Fibromyalgia. Mayo Clin Proc. 2020 Nov;95(11):2442-2461. doi: 10.1016/j.mayocp.2020.04.037. Epub 2020 Aug 17.

  PMID: 32819740 BACKGROUND

• Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.

  PMID: 30453109 BACKGROUND

• Pendry P, Vandagriff JL. Animal Visitation Program (AVP) Reduces Cortisol Levels of University Students: A Randomized Controlled Trial. AERA Open. 2019 Apr-Jun;5(2):1-12. doi:10.1177/2332858419852592.

  BACKGROUND

Related Links

• Azevedo LF, Costa-Pereira A, Mendonça L, Dias CC, Castro-Lopes JM. Tradução, adaptação cultural e validação do Inventário Resumido da Dor (Brief Pain Inventory - Short Form) para a população portuguesa. Dor. 2007;15(4):6-15
• Pereira MG, Machado JC, Alves S, et al. Adaptação e validação da versão portuguesa da Pain Catastrophizing Scale (PCS). Dor. 2017;25(1):16-25
• Oliveira AM, Batalha LMC, Fernandes AM, Gonçalves JC, Viegas RG. Uma análise funcional da Wong-Baker Faces Pain Rating Scale: linearidade, discriminabilidade e amplitude. Rev Enf Ref. 2014;IV(3):121-130
• Direção-Geral da Saúde. Circular Normativa n.º 09/DGCG de 14/06/2003. Dor como 5º sinal vital - Registo sistemático da intensidade da Dor. Lisboa: DGS; 2003

MeSH Terms

Conditions

Fibromyalgia; Pain; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Armando Almeida, Associate Professor

  School of Medicine, University of Minho

  STUDY CHAIR

• Filipa Martins-Alves, Psychiatric Hospital Assistant

  Psychiatry Department, Unidade Local de Saúde (ULS) Alto Ave

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Almeida, Associate Professor

CONTACT

+351 936615717; aalmeida@med.uminho.pt

Filipa Martins-Alves, Psychiatric Hospital Assistant

CONTACT

+351 964770140; id12083@alunos.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)