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

Official title

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

Overview

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).

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.

Interventions

• 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 dog
• 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.

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (2)

• 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]
• Pain catastrophizing [Time frame: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Portugal · 1 center

• Unidade Local de Saúde (ULS) Alto Ave — Guimarães

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07356206 · REF.19/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗