Fibromyalgia (FM)IDAT26NCT07356206
Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia Patients
A study testing Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") in people with Fibromyalgia (FM), run by University of Minho at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Jan 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde (ULS) Alto Ave
Guimarães, 4835-044
Filipa Martins-Alves, Psychiatric Hospital Assistant, +351-964770140, id12083@alunos.uminho.pt
Gerly Macedo, Clinical Psychologist, +351 962913661, gerlymacedo@ulsaave.min-saude.pt
About this study
Official title: 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).
Read the 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.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections"), Behavioral: Psychoeducation and Relaxation without Dogs (Control)
- 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
- Medical subject headings
- Fibromyalgia, Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections")Behavioural
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: Psychoeducation and Relaxation without Dogs (Control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral: Psychoeducation and Relaxation without Dogs (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
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.
Measured: 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.
Measured: 13 months - From 1 month after enrollment to the end of treatment at 12 months after the first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Ave, EPE
- Responsible party
- Principal investigator, Armando Almeida, University of Minho
- Investigators
- Armando Almeida, Associate Professor, Study chair, School of Medicine, University of MinhoFilipa Martins-Alves, Psychiatric Hospital Assistant, Principal investigator, Psychiatry Department, Unidade Local de Saúde (ULS) Alto Ave
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356206
- Sponsor's protocol ID
- REF.19/2024
- Acronym
- IDAT26
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data protection in Portugal is very restricted concerning the sharing of patients' personal data.
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.
PubMed 23170993Clark 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.
PubMed 32397366Kunzi 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.
PubMed 35764668Kang 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.
PubMed 37476701Petersson 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.
PubMed 29081760Beetz 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.
PubMed 22866043Rosado 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.
PubMed 17058362Pais-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.
PubMed 17365902Pandey 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.
PubMed 38606668Renner 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.
PubMed 29035800Malogiannis 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.
PubMed 24650608Clark 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.
PubMed 32819740Arnold 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.
PubMed 30453109Pendry 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Between Paws and Affections: Impact of Dog Assisted Therapy on Pain, Emotional Symptoms, and Functioning in Fibromyalgia
- ClinicalTrials.gov ID
- NCT07356206
- Acronym / sponsor ID
- IDAT26 / REF.19/2024
- Conditions
- Fibromyalgia (FM)
- Keywords
- Fibromyalgia, Dog-Assisted Therapy, Pain, Anxiety, Depression, Psychoeducation and Relaxation, Fuctional Impact, Catastrophizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Ave, EPE
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") | Experimental | Behavioral: 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: Psychoeducation and Relaxation without Dogs (Control) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") |
| 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. | Behavioural | Behavioral: Psychoeducation and Relaxation without Dogs (Control) |
Primary outcome
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.
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 23170993Marcus 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.
- Background: PubMed 32397366Clark 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.
- Background: PubMed 35764668Kunzi 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.
- Background: PubMed 37476701Kang 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.
- Background: PubMed 29081760Petersson 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.
- Background: PubMed 22866043Beetz 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.
- Background: PubMed 17058362Rosado 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.
- Background: PubMed 17365902Pais-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.
- Background: PubMed 38606668Pandey 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.
- Background: PubMed 29035800Renner 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.
- Background: PubMed 24650608Malogiannis 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.
- Background: PubMed 32819740Clark 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.
- 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):6-15Link provided by the sponsor.
- Pereira MG, Machado JC, Alves S, et al. Adaptação e validação da versão portuguesa da Pain Catastrophizing Scale (PCS). Dor. 2017;25(1):16-25Link provided by the sponsor.
- 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):121-130Link provided by the sponsor.
- 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; 2003Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data protection in Portugal is very restricted concerning the sharing of patients' personal data.
Related trials for Fibromyalgia (FM)
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Recruiting
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
Fibromyalgia (FM)
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruiting
Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities
Fibromyalgia, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armando Almeida, Associate Professor study chair
School of Medicine, University of Minho
Filipa Martins-Alves, Psychiatric Hospital Assistant principal investigator
Psychiatry Department, Unidade Local de Saúde (ULS) Alto Ave
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Dog Assisted Therapy (DAT - "Between Paws and Affections") in people with Fibromyalgia (FM), run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armando Almeida, Associate Professor (+351 936615717, aalmeida@med.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07356206, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.