Emotional DistressCUIDA-TENCT04958941
CUIDA-TE, an APP for the Emotional Management
A study testing Experimental: Intervention group in people with Emotional Distress and Burnout, Professional, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study is to develop and validate an Ecological Momentary Intervention APP for healthcare workers, in order to face of work-related stresses generated by the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress, Burnout, Professional, Emotional Stress
- What is being tested?
- Experimental: Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be a healthcare worker in active (from 18 until 67 years)
- to have a smartphone with Internet access and Android operating system.
Who cannot join
- to be in psychological treatment at the time of the recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CUIDA-TE, an APP for the Emotional Management of the Healthcare Professionals
The aim of this study is to develop and validate an Ecological Momentary Intervention APP for healthcare workers, in order to face of work-related stresses generated by the COVID-19 pandemic.
Read the detailed description
The COVID-19 pandemic has had a very high emotional impact on healthcare workers. Ecological momentary interventions (EMI) can offer an intervention in real time, when the emotion arises. CUIDA-TE is an EMI APP based on principles of different transdiagnostic cognitive behavioral interventions focused on emotion regulation. The effectiveness of CUIDA-TE will be investigated in the current study. A two-arms randomized controlled trial (RCT) will be conducted. At least 182 healthcare workers will be randomly assigned to a 2-month immediate intervention group (CUIDA-TE APP, n= 91), or a control group (no assessment or intervention, n=91). The CUIDA-TE consists of an app-based EMI that estimates and intervenes based on ecological momentary assessment data of five emotional states: joy, fatigue, sadness, anxiety, anger, as well as sleep quality, sleep quantity, burnout, perceived stress, and self-perception of coping skills. The primary outcome is the PHQ-9. Secondary outcomes include ERQ, DERS, OASIS, BRS, SUS, and ProQOL questionnaires. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at 3-month follow-up measurement.
- Conditions
- Emotional Distress, Burnout, Professional, Emotional Stress
- Being tested
- Experimental: Intervention group
- Medical subject headings
- Burnout, Professional, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention groupBehavioural
Also called CUIDA-TE APP
During 2 months participants will be able to asses their mood and practice in real time their emotional regulation skills with an ecological momentary interventions APP.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The group will receive the ecological momentary intervention (CUIDA-TE APP). This intervention will allow the individual to learn and practice adaptive ways to regulate their emotions. The protocol contains the following components: Distraction, acceptation skills, re-appraisal and problem-solving skills. Receives: Behavioral: Experimental: Intervention group |
| Control group | No intervention | This condition is a waiting list control group with no intervention. The participants will wait for a period of 3 months. They will be offered the possibility of receiving the intervention APP (CUIDA-TE) after the waiting list period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9)
The PHQ-9 assess depression construct and includes nine items: (1) anhedonia; (2) depressed mood; (3) trouble sleeping; (4) feeling tired; (5) change in appetite; (6) guilt, self-blame, or worthlessness; (7) trouble concentrating; (8) feeling slowed down or restless; and (9) thoughts of being better off dead or hurting oneself. PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). The PHQ-9 score is divided in the following severity categories: 5-9 (mild depression), 10-14 (modera depression), 15-19 (moderately severe depression) and 20 or greater (severe depression).
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess change in Emotion Regulation Questionnaire (ERQ)
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). High score indicates more likely to use this kind of emotion regulation strategies (Reappraisal Items: 1, 3, 5, 7, 8, 10; Suppression Items: 2, 4, 6, 9).
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess change in Difficulties in Emotion Regulation Scale (DERS)
The DERS is a 36-item self-report measure of six facets of emotion regulation. Spanish validated version (Hervás \& Jódar, 2008) has 28-items rated on a scale of 1 to 5. Higher scores indicate more difficulty in emotion regulation.
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess change in Brief Resilience Scale (BRS)
The BRS is a 6-item self-report measure to assess the ability to bounce back or recover from stress. The items are rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). Range from 6 (low resilience) to 30 (high resilience).
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess change in Burnout
Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess change in ProQOL-V
The ProQOL (Professional Quality of Life Scale) was developed as a measure of both the negative and positive effects of working with those who have experienced traumatic stress. The ProQOL has sub-scales for compassion satisfaction, burnout, and compassion fatigue.The responses are rated on 5-point scale, indicating the frequency of each item in the last 30 days (1 = never, 2 = rarely, 3= Sometimes, 4= Often and 5 = Very Often). Higher scores on the compassion satisfaction scale represent a greater satisfaction related to the ability of the professional to be an effective caregiver in his/her job. Higher scores on the burnout scale mean a higher risk for burnout and higher scores in secondary traumatic stress indicate the professional is higher exposed to traumatic events.
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Assess in usability with the System Usability Scale
The System Usability Scale (SUS; Brooke, 1996) is a reliable, 10-item questionnaire that assess the usability of a technology application. The items are rated from 1 ("Strongly disagree") to 5 ("Strongly agree"). The scale is corrected with a formula that allows to obtain scores between 0 -100 points. Unacceptable usability (with SUS scores below 50) could indicate that a user had difficulties while using the program and could be interpreted as a barrier for the clinical effect.
Measured: At 2 months (post intervention)
Assess change in Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item self-report measure to assess anxiety severity and impairment
Measured: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Secondary outcomes (10)
Joy daily item integrated in the APP mobile
Item to assess joy/happiness daily through APP mobile. User will rate the item rating between 0 (No happiness) to 10 (Extremely happiness)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT HAPPINESS 0= No happiness-------------------------------10= Extremely happy
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Measured: During intervention process up to 2 months
Fatigue daily item integrated in the APP mobile
Item to assess Fatigue daily through APP mobile. User will rate the item rating between 0 (No Fatigue) to 10 (Extreme fatigue)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT FATIGUE 0= No fatigue--------------------------------10= Extreme fatigue
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.00-8.
Measured: During intervention process up to 2 months
Sadness daily item integrated in the APP mobile
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Measured: During intervention process up to 2 months
Anxiety daily item integrated in the APP mobile
Item to assess Anxiety daily through APP mobile. User will rate the item rating between 0 (No Anxiety) to 10 (Extremely Anxious)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANXIETY 0= No anxiety-----------------------------10= Extremely anxious
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Measured: During intervention process up to 2 months
anger daily item integrated in the APP mobile
Item to assess Anger daily through APP mobile. User will rate the item rating between 0 (No Anger) to 10 (Extremely Angry)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANGER 0= No anger-------------------------------10= Extremely angry
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Measured: During intervention process up to 2 months
sleep quality daily item integrated in the APP mobile
Item to assess sleep quanlity daily through APP mobile. User will rate if the work have interfered with the quality of sleep rating between 0 (No interference) to 10 (maximum interference)
EXAMPLE ITEM:
Has WORK interfered with the quality of your SLEEP tonight? 0 = No Interference----------------------10 = Maximum Interference
Item elaborated AD HOC for this study
Measured: During intervention process up to 2 months
sleep quantity daily item integrated in the APP mobile
Item to assess sleep quantity daily through APP mobile. The user will rate the number of hours of sleep each day.
EXAMPLE ITEM:
How many hours have you slept in the last 24 hours?
Item elaborated AD HOC for this study
Measured: During intervention process up to 2 months
burnout daily item integrated in the APP mobile
Item to assess the degree of perceived burnout daily through APP mobile. User will rate the item rating between 0 (Totally disagree) to 10 (Totally agree)
EXAMPLE ITEM:
Please, indicate your degree of agreement with the next statement: "I am burned out from my work" 0= totally disagree----------------------------------------10= totally agree
Item adapted from West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. JGen Intern Med. 2009; 24(12):1318-1321. https://doi.org/10.1007/s11606-009-1129-z PMID: 19802645
Measured: During intervention process up to 2 months
perceived stress daily item integrated in the APP mobile
Item to assess perceived stress daily through APP mobile. User will rate the item rating between 0 (No stress) to 10 (Extremely stressed)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT STRESS 0= No stress------------------------------10= Extremely stressed
Item created AD HOC for this study.
Measured: During intervention process up to 2 months
self-perception of coping skills daily item integrated in the APP mobile
Item to assess perceived self-perception of coping skills daily through APP mobile.
User will rate the item rating between 0 (No capable) to 10 (Extremely capable)
EXAMPLE ITEM:
To what extent do you feel CAPABLE OF COPING with your problems right now? 0= No capable---------------------------------10= Extremely capable
Item created AD HOC for this study.
Measured: During intervention process up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start14 Nov 2022
- Primary completion30 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Castilla, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958941
- Sponsor's protocol ID
- UValencia_RCT_CUIDATE
- Acronym
- CUIDA-TE
- Status last verified
- Jan 2024
- First submitted
- 9 Jun 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castilla D, Navarro-Haro MV, Suso-Ribera C, Diaz-Garcia A, Zaragoza I, Garcia-Palacios A. Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol. BMC Psychiatry. 2022 Mar 5;22(1):164. doi: 10.1186/s12888-022-03800-x.
PubMed 35248015
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUIDA-TE, an APP for the Emotional Management of the Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04958941
- Acronym / sponsor ID
- CUIDA-TE / UValencia_RCT_CUIDATE
- Conditions
- Emotional Distress, Burnout, Professional, Emotional Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Jul 2021 (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 aim of this study is to develop and validate an Ecological Momentary Intervention APP for healthcare workers, in order to face of work-related stresses generated by the COVID-19 pandemic.
Detailed description
The COVID-19 pandemic has had a very high emotional impact on healthcare workers. Ecological momentary interventions (EMI) can offer an intervention in real time, when the emotion arises. CUIDA-TE is an EMI APP based on principles of different transdiagnostic cognitive behavioral interventions focused on emotion regulation. The effectiveness of CUIDA-TE will be investigated in the current study. A two-arms randomized controlled trial (RCT) will be conducted. At least 182 healthcare workers will be randomly assigned to a 2-month immediate intervention group (CUIDA-TE APP, n= 91), or a control group (no assessment or intervention, n=91). The CUIDA-TE consists of an app-based EMI that estimates and intervenes based on ecological momentary assessment data of five emotional states: joy, fatigue, sadness, anxiety, anger, as well as sleep quality, sleep quantity, burnout, perceived stress, and self-perception of coping skills. The primary outcome is the PHQ-9. Secondary outcomes include ERQ, DERS, OASIS, BRS, SUS, and ProQOL questionnaires. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at 3-month follow-up measurement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Experimental: Intervention groupThe group will receive the ecological momentary intervention (CUIDA-TE APP). This intervention will allow the individual to learn and practice adaptive ways to regulate their emotions. The protocol contains the following components: Distraction, acceptation skills, re-appraisal and problem-solving skills. |
| Control group | No intervention | –This condition is a waiting list control group with no intervention. The participants will wait for a period of 3 months. They will be offered the possibility of receiving the intervention APP (CUIDA-TE) after the waiting list period. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to be a healthcare worker in active (from 18 until 67 years)
- to have a smartphone with Internet access and Android operating system.
Key exclusion criteria (1 listed)
- to be in psychological treatment at the time of the recruitment
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 |
|---|---|---|
| Experimental: Intervention groupAlso: CUIDA-TE APPDuring 2 months participants will be able to asses their mood and practice in real time their emotional regulation skills with an ecological momentary interventions APP. | Behavioural | Intervention group |
Primary outcome
Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9)
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The PHQ-9 assess depression construct and includes nine items: (1) anhedonia; (2) depressed mood; (3) trouble sleeping; (4) feeling tired; (5) change in appetite; (6) guilt, self-blame, or worthlessness; (7) trouble concentrating; (8) feeling slowed down or restless; and (9) thoughts of being better off dead or hurting oneself. PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). The PHQ-9 score is divided in the following severity categories: 5-9 (mild depression), 10-14 (modera depression), 15-19 (moderately severe depression) and 20 or greater (severe depression).
Assess change in Emotion Regulation Questionnaire (ERQ)
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). High score indicates more likely to use this kind of emotion regulation strategies (Reappraisal Items: 1, 3, 5, 7, 8, 10; Suppression Items: 2, 4, 6, 9).
Assess change in Difficulties in Emotion Regulation Scale (DERS)
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The DERS is a 36-item self-report measure of six facets of emotion regulation. Spanish validated version (Hervás \& Jódar, 2008) has 28-items rated on a scale of 1 to 5. Higher scores indicate more difficulty in emotion regulation.
Assess change in Brief Resilience Scale (BRS)
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The BRS is a 6-item self-report measure to assess the ability to bounce back or recover from stress. The items are rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). Range from 6 (low resilience) to 30 (high resilience).
Assess change in Burnout
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.
Assess change in ProQOL-V
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The ProQOL (Professional Quality of Life Scale) was developed as a measure of both the negative and positive effects of working with those who have experienced traumatic stress. The ProQOL has sub-scales for compassion satisfaction, burnout, and compassion fatigue.The responses are rated on 5-point scale, indicating the frequency of each item in the last 30 days (1 = never, 2 = rarely, 3= Sometimes, 4= Often and 5 = Very Often). Higher scores on the compassion satisfaction scale represent a greater satisfaction related to the ability of the professional to be an effective caregiver in his/her job. Higher scores on the burnout scale mean a higher risk for burnout and higher scores in secondary traumatic stress indicate the professional is higher exposed to traumatic events.
Assess in usability with the System Usability Scale
Time frame: At 2 months (post intervention)
The System Usability Scale (SUS; Brooke, 1996) is a reliable, 10-item questionnaire that assess the usability of a technology application. The items are rated from 1 ("Strongly disagree") to 5 ("Strongly agree"). The scale is corrected with a formula that allows to obtain scores between 0 -100 points. Unacceptable usability (with SUS scores below 50) could indicate that a user had difficulties while using the program and could be interpreted as a barrier for the clinical effect.
Assess change in Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The OASIS is a 5-item self-report measure to assess anxiety severity and impairment
10 secondary outcomes
Joy daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
Fatigue daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
Sadness daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
Anxiety daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
anger daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
sleep quality daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
sleep quantity daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
burnout daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
perceived stress daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
self-perception of coping skills daily item integrated in the APP mobile
Time frame: During intervention process up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 35248015Castilla D, Navarro-Haro MV, Suso-Ribera C, Diaz-Garcia A, Zaragoza I, Garcia-Palacios A. Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol. BMC Psychiatry. 2022 Mar 5;22(1):164. doi: 10.1186/s12888-022-03800-x.
- CUIDA-TE APPLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Emotional Distress
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
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. This study is not recruiting at the moment.
Diana Castilla, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention group in people with Emotional Distress and Burnout, Professional, run by University of Valencia 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9) (time frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)). The study lists 8 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 NCT04958941, which also lists 1 linked publication.
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 17 Jan 2024.