An interventional study of Heart rate variability biofeedback in Caregiver Stress, Caregiver Burden and Psychological Stress, sponsored by Instituto de Investigación Marqués de Valdecilla. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Instituto de Investigación Marqués de Valdecilla · Not applicable, Interventional, and Supportive care
Among 10 studies in Caregiver Burden with a site in Spain — 3 open to participants now, 4 under way, none of them phase 3. Caregiver Burden · Spain.
Among the 10 studies in Caregiver Burden with a site in Spain, this one is one of 2 that started in 2026, is one of 8 with no phase, and was the 10th registered.
501 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
Browse Caregiver Burden studies →3 of the 10 studies in Caregiver Burden with a site in Spain are open now. Recruiting first, the newest first:
Adhera Health, Inc. · Sites in Spain
Ages 18+ · Healthy volunteers
University of Deusto · Sites in Spain
Ages 18–100
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 88 Caregiver Burden studies recruiting now, 67 (76%) set no upper age limit and 7 (8%) stop at 75 or younger; 8 take children under 18; 38 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 100 is above the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Median enrollment 81 across the 8 interventional studies, 624 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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2 of 10 have an industry lead sponsor. The 10 most frequent:
Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 34 studies on the registry; 12 are open to participants now.
Instituto de Investigación Marqués de Valdecilla has 1 study filed under Caregiver Burden — fewer than ten, so there is no comparison to draw.
1 of the studies in Caregiver Burden with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07793682Althaia Xarxa Assistencial Universitària de ManresaEarly Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke | 2026-11-25 |
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Among the 10 studies in Caregiver Burden with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate whether a nurse-led heart rate variability (HRV) biofeedback programme supported by a low-cost wearable sensor reduces autonomic dysregulation and perceived stress in informal caregivers of people with dementia. Participants will be prospectively allocated, without randomization, at the day-care-centre level. Before enrolment, the six centres will be characterised according to centre size, estimated number of eligible caregivers and expected recruitment volume, and arranged into three approximately matched pairs. One centre in each pair will implement CARE-COHERENCE and the other will serve as a concurrent comparison centre under a pre-specified operational implementation plan. Follow-up will continue for 12 months.
Approximately 100 informal caregivers of older people with dementia attending one of six participating day-care centres will be enrolled. The intervention group will receive an 8-week HRV-biofeedback programme in addition to usual caregiver support. The comparison group will receive usual caregiver support during the 12-month study period and will be offered access to programme materials after completion of the final assessment. The primary outcome is change in resting root mean square of successive differences (RMSSD) from baseline to 6 months. Perceived stress is the key secondary outcome. Assessments occur at baseline, 8 weeks, 6 months and 12 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive an 8-week nurse-led heart rate variability (HRV) biofeedback program in addition to usual caregiver support. At program entry, an individual resonance frequency is determined using paced-breathing trials across a prespecified range of approximately 4.5 to 6.5 breaths per minute. The active phase comprises four weekly nurse-led sessions of approximately 60 minutes during weeks 1-4, followed by structured supported home practice during weeks 5-8. Sessions cover the physiological rationale for HRV biofeedback, paced breathing at the selected training frequency, interpretation of simple wearable feedback, management of common practice difficulties, and a brief positive-emotion self-regulation strategy. Participants are encouraged to practice approximately 10 minutes twice daily, or to reach a minimum accumulated practice target of 70 minutes per week. One booster contact occurs at month 3.
Behavioral: Heart rate variability biofeedback
Participants continue to receive usual caregiver support, including routine clinical care, information, and standard services available through the participating day-care centers and other routine health and social care services. They do not receive structured resonance-frequency breathing training or HRV biofeedback from the study team at any point during the 12-month study period. After the 12-month assessment, participants in this group will be offered access to the CARE-COHERENCE educational materials and a program orientation session.
Nurse-delivered behavioral self-regulation training combining individualized resonance-frequency paced breathing with real-time HRV feedback from a low-cost wrist- or chest-worn sensor capable of recording interbeat intervals, paired with a compatible training application. Dose: four supervised sessions of approximately 60 minutes in weeks 1-4, delivered individually or in small groups, followed by supported home practice in weeks 5-8 (target 10 minutes twice daily, or at least 70 accumulated minutes per week), plus one booster contact at month 3. Training frequency is set per participant during an initial paced-breathing assessment across approximately 4.5-6.5 breaths per minute. A brief positive-emotion self-regulation strategy is included. The device model, firmware, and application version are prespecified before recruitment and held constant where possible. Adherence is derived from device and application logs and a participant practice log.
Also known as: CARE-COHERENCE program, Resonance frequency breathing training
Change in resting RMSSD
Root mean square of successive differences (RMSSD) derived from a standardised resting interbeat-interval recording obtained with the study wearable sensor and processed according to a prespecified HRV analysis protocol. Higher values indicate greater vagally mediated heart rate variability.
Time frame: Baseline and 6 months
Change in perceived stress (Perceived Stress Scale, PSS-10)
Perceived stress measured with the 10-item Perceived Stress Scale (PSS-10). Total score ranges from 0 to 40. Higher scores indicate greater perceived stress; a decrease indicates improvement. Analyzed as change from baseline and as the follow-up value adjusted for the baseline score. This is the key secondary outcome.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Maintenance of resting RMSSD at 12 months
Root mean square of successive differences (RMSSD, in milliseconds) derived from a standardized resting interbeat-interval recording obtained with the study wearable sensor and processed with the prespecified HRV analysis pipeline. Higher values indicate greater vagally mediated heart rate variability. Assesses whether any intervention effect on the primary outcome is maintained six months after the primary endpoint.
Time frame: Baseline and 12 months
Change in caregiver burden (Zarit Burden Interview, ZBI-22)
Caregiver burden measured with the 22-item Zarit Burden Interview. Total score ranges from 0 to 88. Higher scores indicate greater burden; a decrease indicates improvement.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Change in resting SDNN
Standard deviation of normal-to-normal interbeat intervals (SDNN, in milliseconds) from the same standardized resting recording used for the primary outcome. Higher values indicate greater overall heart rate variability.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Change in mean resting heart rate
Mean heart rate in beats per minute derived from the standardized resting interbeat-interval recording.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Change in well-being (WHO-5 Well-Being Index)
Well-being measured with the five-item WHO-5 Well-Being Index. The raw score ranges from 0 to 25 and is multiplied by 4 to give a percentage score from 0 to 100. Higher scores indicate better well-being; an increase indicates improvement.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Change in anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS)
Symptoms measured with the Hospital Anxiety and Depression Scale. The HADS-Anxiety and HADS-Depression subscales are reported separately; each ranges from 0 to 21. Higher scores indicate more severe symptoms; a decrease indicates improvement.
Time frame: Baseline, 8 weeks, 6 months and 12 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication, together with the data dictionary, may be made available to qualified researchers whose proposed use has been approved by the study team. Data will be shared subject to a data-sharing agreement, applicable ethics committee requirements, and EU General Data Protection Regulation and Spanish data-protection law. Requests should be addressed to the corresponding author.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary results report, with no specified end date.
Access criteria: Requests from qualified researchers with a methodologically sound proposal, reviewed by the study team, and subject to a signed data-sharing agreement and to applicable ethics and EU/Spanish data-protection requirements. Requests should be sent to the corresponding author.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2028, 18 months after the start.
Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 18 months is close to that.
Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Instituto de Investigación Marqués de Valdecilla