Healthy VolunteersRRCENCT07884435
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
A study testing Active IVR Group and Passive IVR Goup in people with Healthy Volunteers and Aging, Healthy, run by Francisco Antonio Nieto Escámez at 1 site in Spain.
Trial summary
This randomized controlled trial (N = 60) evaluates the acceptability and efficacy of an immersive virtual reality (IVR) intervention designed to enhance psychological well-being in older adults without cognitive impairment living in long-term care facilities. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Aging, Healthy
- What is being tested?
- Active IVR Group and Passive IVR Goup
- 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 siteSpain
- Study dates
- 15 Oct 2026to Jan 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Residence in a long-term care facility for at least 3 months
- Absence of significant cognitive impairment (MMSE ≥ 21)
- Able to provide informed consent or have a legal representative who can do so. (5 )Able to remain seated for approximately 20 minutes per session.
- Willing to participate in 12 VR sessions over four weeks.
Who cannot join
- Cognitive impairment that prevents understanding instructions or interacting with VR content.
- Severe psychopathological diagnosis or active psychiatric disorder requiring acute clinical management.
- Severe sensory impairments.
- Medical or neurological conditions that contraindicate VR exposure (e.g., uncontrolled epilepsy, severe motion sickness).
- Acute medical instability or conditions requiring urgent clinical intervention.
- Any condition judged by clinical staff to pose a safety risk during VR immersion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
The intervention is implemented across three long-term care facilities located in Sevilla, Spain.
Seville
Francisco Antonio Nieto-Escamez, PhD, +34 950214628, pnieto@ual.es
Ana Belen Garcia-Lopez, B.A, +34 654466399, agl002@inlumine.ual.es
About this study
Official title: Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality ((Reminiscence - Relaxation - Cultural Experiences)
This randomized controlled trial (N = 60) evaluates the acceptability and efficacy of an immersive virtual reality (IVR) intervention designed to enhance psychological well-being in older adults without cognitive impairment living in long-term care facilities. The intervention protocol consists of 12 sessions combining guided reminiscence, relaxation, and virtual cultural experiences. In addition, the study analyzes participants' speech and prosody during the sessions to evaluate emotional responses elicited by the virtual environments.
Read the detailed description
This study evaluates the implementation of "Well-being RRCE," an immersive virtual reality (IVR) protocol designed for cognitively intact older adults living in long-term care. The intervention consists of 12 guided IVR sessions, using Meta Quest 2 head-mounted displays and browser-based WebXR environments developed to ensure accessibility and comfort. Following an initial pilot study with 12 participants that demonstrated feasibility, safety, and acceptability. This randomized controlled trial involves a total targeted sample of 60 participants (N = 60).
Participants are randomly allocated into three groups:
Active IVR Group: Participants receive the full 12-session "Well-Being RRCE" protocol, administered in small groups (2-4 participants), 3 times per week over 4 weeks (20 minutes per session). The protocol integrates three distinct intervention components: Reminiscence, Relaxation, and Cultural Experiences. Their verbal interactions are recorded via headworn microphones for exploratory qualitative and affective analysis.
Passive IVR Group: Participants undergo 12 sessions over 4 weeks (3 times per week, 20 minutes/session) administered in small groups (2-4 participants) of non-interactive exposure to immersive virtual environments of architectural or cultural interest with basic descriptive information provided by a facilitator, without guided reminiscence, relaxation, or discourse recording.
Control Group: Participants receive usual care and continue their standard facility routines (news workshops, gerontological exercise, cognitive stimulation, recreational activities, and guided walks) without receiving any IVR exposure.
The primary objective of this study is to examine the effect of the intervention on protocol acceptability and participants' subjective well-being. Additionally, it aims to evaluate the level of emotional response experienced by participants by analyzing their speech discourse and prosody during the different IVR sessions.
- Conditions
- Healthy Volunteers, Aging, Healthy
- Being tested
- Active IVR Group, Passive IVR Goup
- Keywords
- virtual reality exposure, older adults, Long-Term Care, Residential Facilities, Psychological Well-Being, Immersive Virtual Reality, Avatar-Based Intervention, Eudaimonic Well-Being, Ryff's Model, Dignity-by-Design, Institutionalized Older Adults
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active IVR GroupBehavioural
Participants undergo twelve 20-minute sessions of active immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session includes interactive, guided experiential tasks within virtual environments tailored to reminiscence, relaxation, and cultural experiences. During these active sessions, participants respond verbally to structured prompts provided by the facilitator, and their speech audio is recorded for subsequent prosodic and emotional analysis
Passive IVR GoupBehavioural
Participants undergo twelve 20-minute sessions of passive immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session consists of observational exposure strictly to cultural environments that are distinct from those used in the active condition. During sessions, participants passively view these unique virtual scenarios while a facilitator provides a brief, standardized description of the space.
| Study group | Role | What they receive |
|---|---|---|
| Active IVR Group | Experimental | Participants complete the full Well-Being RRCE protocol, consisting of twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of guided experiential tasks within immersive virtual environments focused on reminiscence, relaxation, and cultural experiences. Participants will answer questions during the guided sessions, and their audio responses will be recorded for subsequent analysis. Receives: Behavioral: Active IVR Group |
| Passive IVR Group | Experimental | Participants complete twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of passive exposure to virtual environments, during which the activity guide provides a brief description of the virtual space the participants are viewing, without requiring active tasks or participant responses. Receives: Behavioral: Passive IVR Goup |
| Control Group | No intervention | Participants do not receive any immersive virtual reality sessions. They complete baseline, mid-intervention, and post-intervention assessments on the same timeline as the IVR groups to complete the evaluations appropriate for their condition. Participants continue to receive their usual care within the long-term care facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect (I-PANAS-SF)
Positive and negative affect will be assessed using the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). The questionnaire contains 10 items rated on a 5-point Likert scale and yields separate Positive Affect and Negative Affect subscale scores ranging from 5 to 25. Higher Positive Affect scores indicate greater positive affect, whereas higher Negative Affect scores indicate greater negative affect.
Measured: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Affect Balance (EBA)
Affect balance will be assessed using the Affect Balance Scale (Escala de Balance Afectivo, EBA; Godoy-Izquierdo et al., 2008). The instrument contains 18 items rated on a 3-point Likert scale and comprises Positive Affect and Negative Affect subscales (9 items each). An Affect Balance Index is calculated by subtracting the Negative Affect score from the Positive Affect score, yielding a total score ranging from -18 to +18. Higher scores indicate a more positive affective balance, whereas lower scores indicate a predominance of negative affect.
Measured: Assessed at baseline (T0), at the end of each intervention week (sessions 3, 6, 9, and 12), and 1 week after completion of the intervention (T1).
Life Satisfaction (SWLS)
Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS). The instrument consists of 5 items rated on a 7-point Likert scale with visual support, yielding a total score ranging from 5 to 35. Higher scores indicate greater satisfaction with life.
Measured: Assessed at baseline (T0) and 1 week after completion of the intervention (T1).
Self-Perceived Well-Being
Self-perceived well-being will be assessed using a single-item numerical rating scale ranging from 1 to 10. Participants in the IVR intervention groups will rate their immediate post-session well-being. Higher scores indicate greater perceived well-being.
Measured: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
State Anxiety (STAIr-State)
State anxiety will be assessed using the State subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 6 dichotomous items, yielding scores ranging from 0 to 6. Higher scores indicate higher levels of state anxiety.
Measured: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Trait Anxiety (STAIr-Trait)
Trait anxiety will be assessed using the Trait subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 7 dichotomous items, yielding scores ranging from 0 to 7. Higher scores indicate higher levels of trait anxiety.
Measured: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Secondary outcomes (2)
Acceptability of the Intervention (NPT-ES)
Acceptability of the intervention will be assessed using the adapted Non-Pharmacological Therapy Experience Scale (NPT-ES). This facilitator-rated scale consists of 5 items evaluating participation, pleasure, relationships with others, discomfort, and rejection, each rated on a 4-point scale (0-3). Item scores are summed to generate a total score ranging from 0 to 15, with higher scores indicating a more positive intervention experience and greater acceptability.
Measured: Assessed immediately following each intervention session (12 sessions).
Participant Feedback on Virtual Environments
Participants in the immersive virtual reality intervention groups will complete an ad hoc 5-item questionnaire after each session. Responses are recorded as Yes/No and assess whether the virtual environments elicited feelings of excitement, calmness, discomfort, restlessness, and perceived realism.
Measured: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a three-arm parallel design in which participants are allocated to one of three conditions (Active IVR, Passive IVR, or Control). All groups follow a matched assessment timeline, although only the IVR groups complete session-based measures (e.g., NPT-ES, qualitative feedback, and self-perceived well-being). The Control group completes baseline, mid-intervention, and post-intervention assessments on the same schedule but does not undergo IVR sessions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Antonio Nieto Escámez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Antonio Nieto Escámez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884435
- Sponsor's protocol ID
- WELLBEING-RRCE-001
- Other IDs
- P_FORT_CENTROS_2023/04
- Acronym
- RRCE
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Restout J, Bernache-Assollant I, Morizio C, Boujut A, Angelini L, Tchalla A, Perrochon A. Fully Immersive Virtual Reality Using 360 degrees Videos to Manage Well-Being in Older Adults: A Scoping Review. J Am Med Dir Assoc. 2023 Apr;24(4):564-572. doi: 10.1016/j.jamda.2022.12.026. Epub 2023 Feb 6.
PubMed 36758621Brimelow RE, Dawe B, Dissanayaka N. Preliminary Research: Virtual Reality in Residential Aged Care to Reduce Apathy and Improve Mood. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):165-170. doi: 10.1089/cyber.2019.0286. Epub 2019 Dec 12.
PubMed 31829729
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality ((Reminiscence - Relaxation - Cultural Experiences)
- ClinicalTrials.gov ID
- NCT07884435
- Acronym / sponsor ID
- RRCE / WELLBEING-RRCE-001
- Conditions
- Healthy Volunteers, Aging, Healthy
- Keywords
- virtual reality exposure, older adults, Long-Term Care, Residential Facilities, Psychological Well-Being, Immersive Virtual Reality, Avatar-Based Intervention, Eudaimonic Well-Being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Francisco Antonio Nieto EscámezUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Oct 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.
This randomized controlled trial (N = 60) evaluates the acceptability and efficacy of an immersive virtual reality (IVR) intervention designed to enhance psychological well-being in older adults without cognitive impairment living in long-term care facilities. The intervention protocol consists of 12 sessions combining guided reminiscence, relaxation, and virtual cultural experiences. In addition, the study analyzes participants' speech and prosody during the sessions to evaluate emotional responses elicited by the virtual environments.
Detailed description
This study evaluates the implementation of "Well-being RRCE," an immersive virtual reality (IVR) protocol designed for cognitively intact older adults living in long-term care. The intervention consists of 12 guided IVR sessions, using Meta Quest 2 head-mounted displays and browser-based WebXR environments developed to ensure accessibility and comfort. Following an initial pilot study with 12 participants that demonstrated feasibility, safety, and acceptability. This randomized controlled trial involves a total targeted sample of 60 participants (N = 60).
Participants are randomly allocated into three groups:
Active IVR Group: Participants receive the full 12-session "Well-Being RRCE" protocol, administered in small groups (2-4 participants), 3 times per week over 4 weeks (20 minutes per session). The protocol integrates three distinct intervention components: Reminiscence, Relaxation, and Cultural Experiences. Their verbal interactions are recorded via headworn microphones for exploratory qualitative and affective analysis.
Passive IVR Group: Participants undergo 12 sessions over 4 weeks (3 times per week, 20 minutes/session) administered in small groups (2-4 participants) of non-interactive exposure to immersive virtual environments of architectural or cultural interest with basic descriptive information provided by a facilitator, without guided reminiscence, relaxation, or discourse recording.
Control Group: Participants receive usual care and continue their standard facility routines (news workshops, gerontological exercise, cognitive stimulation, recreational activities, and guided walks) without receiving any IVR exposure.
The primary objective of this study is to examine the effect of the intervention on protocol acceptability and participants' subjective well-being. Additionally, it aims to evaluate the level of emotional response experienced by participants by analyzing their speech discourse and prosody during the different IVR sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study uses a three-arm parallel design in which participants are allocated to one of three conditions (Active IVR, Passive IVR, or Control). All groups follow a matched assessment timeline, although only the IVR groups complete session-based measures (e.g., NPT-ES, qualitative feedback, and self-perceived well-being). The Control group completes baseline, mid-intervention, and post-intervention assessments on the same schedule but does not undergo IVR sessions.
| Arm | Type | Receives |
|---|---|---|
| Active IVR Group | Experimental | Behavioral: Active IVR GroupParticipants complete the full Well-Being RRCE protocol, consisting of twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of guided experiential tasks within immersive virtual environments focused on reminiscence, relaxation, and cultural experiences. Participants will answer questions during the guided sessions, and their audio responses will be recorded for subsequent analysis. |
| Passive IVR Group | Experimental | Behavioral: Passive IVR GoupParticipants complete twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of passive exposure to virtual environments, during which the activity guide provides a brief description of the virtual space the participants are viewing, without requiring active tasks or participant responses. |
| Control Group | No intervention | –Participants do not receive any immersive virtual reality sessions. They complete baseline, mid-intervention, and post-intervention assessments on the same timeline as the IVR groups to complete the evaluations appropriate for their condition. Participants continue to receive their usual care within the long-term care facility. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 60 years
- Residence in a long-term care facility for at least 3 months
- Absence of significant cognitive impairment (MMSE ≥ 21)
- Able to provide informed consent or have a legal representative who can do so. (5 )Able to remain seated for approximately 20 minutes per session.
- Willing to participate in 12 VR sessions over four weeks.
Key exclusion criteria (6 listed)
- Cognitive impairment that prevents understanding instructions or interacting with VR content.
- Severe psychopathological diagnosis or active psychiatric disorder requiring acute clinical management.
- Severe sensory impairments.
- Medical or neurological conditions that contraindicate VR exposure (e.g., uncontrolled epilepsy, severe motion sickness).
- Acute medical instability or conditions requiring urgent clinical 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 |
|---|---|---|
| Active IVR GroupParticipants undergo twelve 20-minute sessions of active immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session includes interactive, guided experiential tasks within virtual environments tailored to reminiscence, relaxation, and cultural experiences. During these active sessions, participants respond verbally to structured prompts provided by the facilitator, and their speech audio is recorded for subsequent prosodic and emotional analysis | Behavioural | Active IVR Group |
| Passive IVR GoupParticipants undergo twelve 20-minute sessions of passive immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session consists of observational exposure strictly to cultural environments that are distinct from those used in the active condition. During sessions, participants passively view these unique virtual scenarios while a facilitator provides a brief, standardized description of the space. | Behavioural | Passive IVR Group |
Primary outcome
Positive and Negative Affect (I-PANAS-SF)
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Positive and negative affect will be assessed using the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). The questionnaire contains 10 items rated on a 5-point Likert scale and yields separate Positive Affect and Negative Affect subscale scores ranging from 5 to 25. Higher Positive Affect scores indicate greater positive affect, whereas higher Negative Affect scores indicate greater negative affect.
Affect Balance (EBA)
Time frame: Assessed at baseline (T0), at the end of each intervention week (sessions 3, 6, 9, and 12), and 1 week after completion of the intervention (T1).
Affect balance will be assessed using the Affect Balance Scale (Escala de Balance Afectivo, EBA; Godoy-Izquierdo et al., 2008). The instrument contains 18 items rated on a 3-point Likert scale and comprises Positive Affect and Negative Affect subscales (9 items each). An Affect Balance Index is calculated by subtracting the Negative Affect score from the Positive Affect score, yielding a total score ranging from -18 to +18. Higher scores indicate a more positive affective balance, whereas lower scores indicate a predominance of negative affect.
Life Satisfaction (SWLS)
Time frame: Assessed at baseline (T0) and 1 week after completion of the intervention (T1).
Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS). The instrument consists of 5 items rated on a 7-point Likert scale with visual support, yielding a total score ranging from 5 to 35. Higher scores indicate greater satisfaction with life.
Self-Perceived Well-Being
Time frame: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
Self-perceived well-being will be assessed using a single-item numerical rating scale ranging from 1 to 10. Participants in the IVR intervention groups will rate their immediate post-session well-being. Higher scores indicate greater perceived well-being.
State Anxiety (STAIr-State)
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
State anxiety will be assessed using the State subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 6 dichotomous items, yielding scores ranging from 0 to 6. Higher scores indicate higher levels of state anxiety.
Trait Anxiety (STAIr-Trait)
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Trait anxiety will be assessed using the Trait subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 7 dichotomous items, yielding scores ranging from 0 to 7. Higher scores indicate higher levels of trait anxiety.
2 secondary outcomes
Acceptability of the Intervention (NPT-ES)
Time frame: Assessed immediately following each intervention session (12 sessions).
Participant Feedback on Virtual Environments
Time frame: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
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 20 Oct 2026.
- Background: PubMed 36758621Restout J, Bernache-Assollant I, Morizio C, Boujut A, Angelini L, Tchalla A, Perrochon A. Fully Immersive Virtual Reality Using 360 degrees Videos to Manage Well-Being in Older Adults: A Scoping Review. J Am Med Dir Assoc. 2023 Apr;24(4):564-572. doi: 10.1016/j.jamda.2022.12.026. Epub 2023 Feb 6.
- Background: PubMed 31829729Brimelow RE, Dawe B, Dissanayaka N. Preliminary Research: Virtual Reality in Residential Aged Care to Reduce Apathy and Improve Mood. Cyberpsychol Behav Soc Netw. 2020 Mar;23(3):165-170. doi: 10.1089/cyber.2019.0286. Epub 2019 Dec 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active IVR Group and Passive IVR Goup in people with Healthy Volunteers and Aging, Healthy, run by Francisco Antonio Nieto Escámez at 1 site in Spain.
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 5 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: opening soon, as of the sponsor's last update on 20 Oct 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 Spain. 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 Francisco Antonio Nieto-Escamez, PhD (+34 950214628, pnieto@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Affect (I-PANAS-SF) (time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).). The study lists 6 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 NCT07884435, which also lists 2 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 20 Oct 2026.