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| Name | Class |
|---|---|
| Unidade Local de Saúde do Alto Ave, EPE | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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: 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month |
| Pain catastrophizing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armando Almeida, Associate Professor | Contact | +351 936615717 | aalmeida@med.uminho.pt | |
| Filipa Martins-Alves, Psychiatric Hospital Assistant | Contact | +351 964770140 | id12083@alunos.uminho.pt |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde (ULS) Alto Ave | Recruiting | Guimarães | 4835-044 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23170993 | Background | 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. | |
| 32397366 | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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Data protection in Portugal is very restricted concerning the sharing of patients' personal data.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| 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. |
|
(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 |
| 35764668 | 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. |
| 37476701 | 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. |
| 29081760 | 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. |
| 22866043 | 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. |
| 17058362 | 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. |
| 17365902 | 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. |
| 38606668 | 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. |
| 29035800 | 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. |
| 24650608 | 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. |
| 32819740 | 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. |
| 30453109 | 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. |
| 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. |
| 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 | View source |
| 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 | View source |
| 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 | View source |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |