DepressionREPICALNCT05526235
A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities
A study testing Doing What Matters (DWM), Problem Management Plus (PM+) and Psychological First Aid (PFA) in people with Depression and Anxiety, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
The current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters [DWM] and Problem Management Plus [PM+]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Psychological Distress
- What is being tested?
- Doing What Matters (DWM), Problem Management Plus (PM+) and Psychological First Aid (PFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 27 Sep 2022to Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older;
- Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).
- Written/digital informed consent before entering the study.
- Being a worker in a long-term care facility or a home care worker in the community of Catalonia.
Who cannot join
- Having acute medical conditions (requiring hospitalization)
- Imminent suicide risk, or expressed acute needs, or protection risks that require immediate follow-up
- Having a severe mental disorder (e.g., psychotic disorders, substance-dependence)
- Having severe cognitive impairment (e.g., severe intellectual disability or dementia)
- Currently specialized psychological treatment (e.g., Eye movement desensitization and reprocessing, Cognitive behavioral therapy)
- In case of current psychotropic medication use, being on an unstable dose for at least 2 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08930
Josep Maria Haro, MD, PHD
About this study
Official title: Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities
The current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters [DWM] and Problem Management Plus [PM+]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19 pandemic.
Read the detailed description
Background: The COVID-19 pandemic has impacted the mental health of long-term care workers (LTCWs). This study combines two low-intensity psychological interventions developed by the World Health Organization (Doing What Matters [DWM] and Problem Management Plus [PM+]) into a stepped-care program for LTCWs.
Objective: To evaluate the implementation of a stepped-care program (DWM; PM+) amongst LTCWs following changes in care due to the COVID-19 pandemic in terms of mental distress, resilience and wellbeing.
Study design: A randomized controlled implementation trial with a single-blinded, parallel-group design.
Study population: Long-term care workers (including workers of assisted living facilities and home care) with self-reported elevated psychological distress.
Intervention-study: All participants (in both the treatment and the comparison group) will receive Psychological First Aid (PFA) and care as usual (CAU). In addition to PFA and CAU, the treatment group will receive the stepped-care intervention (DWM with or without PM+). The stepped-care intervention consists of DWM (step 1) and conditionally PM+ (step 2) if participants still meet criteria for psychological distress (Kessler Psychological Distress scale (K10) >15.9) 1 month after having received DWM.
Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered through phone calls. All assessments will be online and will take place at baseline, 2 weeks after having received DWM, 1 week after having received PM+ and 2 months after PM+. The main study parameter will be the decrease of anxiety and depressive symptoms from baseline to two-month follow-up, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS).
- Conditions
- Depression, Anxiety, Psychological Distress
- Being tested
- Doing What Matters (DWM), Problem Management Plus (PM+), Psychological First Aid (PFA)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doing What Matters (DWM)Behavioural
Also called Doing What Matters in Times of Stress, Self Help Plus, DWM, SH+
The original DWM program consists of a self-help guide called 'Doing What Matters in Times of Stress', that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. In this study, DWM will be delivered as an online intervention. The DWM intervention, i.e. both the audio recordings and the self-help guide, has been adapted for use on a smartphone or other device with internet access. The format of DWM is innovative in that it seeks to ensure that key intervention components are delivered as intended through the use of pre-recorded audio, without the burden of extensive training and supervision. In the online application tool a new module is released every week so participants will be asked to go through the entire DWM intervention within 5 weeks with weekly guidance from a helper.
Problem Management Plus (PM+)Behavioural
Also called PM+
PM+ is a new, brief, psychological intervention program based on cognitive behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support. Across the five 90-minute sessions participants may talk to trained non-professional. PM+ has four core features, and it is brief. In this study, the delivery mode of the PM+ intervention will be flexible, with remote delivery in phases of the pandemic when physical distancing rules apply. This is a future-oriented attempt towards a more holistic mental health care system that can flexibly switch between modes of delivery (e.g. remotely (e.g. Zoom) or face-to), depending on the needs and the specific containment measures that apply, and the specific preferences and needs of the participant.
Psychological First Aid (PFA)Behavioural
Also called PFA
PFA is a brief intervention consisting of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources.
| Study group | Role | What they receive |
|---|---|---|
| Stepped-care program (Step 1: DWM; Step 2: PM+) | Experimental | The treatment group will first receive Psychological First Aid (PFA). PFA consists of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources.
Afterwards participants will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2). Step 2 will only be provided if the participant still has elevated levels of psychological distress (i.e. during the second quantitative assessment at 2 weeks after DWM).
Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria.
Interventions:
Behavioral: Doing What Matters (DWM) Behavioral: Problem Management Plus (PM+) Behavioral: Psychological First Aid (PFA) Receives: Behavioral: Doing What Matters (DWM); Behavioral: Problem Management Plus (PM+); Behavioral: Psychological First Aid (PFA) |
| Psychological First Aid (PFA) | Active comparator | Participants allocated to the control arm will also receive PFA. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria.
Intervention: Behavioral: Psychological First Aid (PFA) Receives: Behavioral: Psychological First Aid (PFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
The PHQ-ADS is a 16-item self-reported instrument that combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale-as a composite measure of depression and anxiety. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Measured: Change from baseline to 20 weeks
Secondary outcomes (6)
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
The PHQ-ADS is a 16-item self-reported instrument that combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale-as a composite measure of depression and anxiety. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Measured: Change: Baseline, 6 weeks, and 12 weeks
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 27, with higher scores indicating higher levels of depression.
Measured: Baseline, 6 weeks, 12 weeks, and 20 weeks
Generalized Anxiety Disorder (GAD-7) scale
The GAD-7 is a 7-item self-reported instrument that measures anxiety symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 21, with higher scores indicating higher levels of anxiety.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - 8-item version
The PCL-5 is a self-reported instrument that measures PTSD symptoms. Respondents are asked how much each symptom has bothered them over the past 4 weeks, with response options of "not at all", "a little bit", "moderately", "quite a bit", and "extremely". Items are rated on a 0-4 scale. The scale can range from 0 to 32 for the 8-item version, with higher scores indicating higher levels of PTSD symptoms.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)
The EQ-5D-5L measures quality of life and consists of two parts, the EQ-5D and the EQ VAS. Part 1, the EQ-5D, rates the level of impairment across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The labels for the 5L followed the format "no problems," "slight problems," "moderate problems," "severe problems," and "unable to"/"extreme problems" for all dimensions. For mobility, the description of "confined to bed" has been changed to "unable to walk about.". Part 2, the EQ-VAS, is a visual analogue scale. The endpoints of the scale are called 'The best health you can imagine' and 'The worst health you can imagine' and the current health status of that day needs to be indicated, after which the number checked on the scale also needs to be written down. Higher scores indicate worst qualitive of life.
Measured: Baseline, 6 weeks, 12 weeks, and 20 weeks
Client Service Receipt Inventory (CSRI) - adaptation
The CSRI was developed for the collection of data on service utilization (e.g. use of health system, other services, time out of employment and other usual activities, need for informal care) and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research. The RESPOND-adapted version consists of a 13-item self-reported instrument that asks about the number and duration of contacts with healthcare professionals (physicians, mental health specialists, and nurses) in the past two months.
Measured: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start27 Sep 2022
- Primary completionMay 2024 (estimated)
- Study completionSep 2024 (estimated)
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 DepressionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Universidad Autonoma de Madrid
- Responsible party
- Sponsor
- Investigators
- Josep Maria Haro, MD,PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526235
- Sponsor's protocol ID
- 202114
- Acronym
- REPICAL
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gonzalez-Spinoglio L, Esplugues-Tormo M, Gine-Vazquez I, Rodeiro-Boliart J, Aguilar-Ortiz S, Ayuso-Mateos JL, McGreevy KR, Mediavilla R, Roos R, Sijbrandij M, Witteveen AB, Haro JM, Felez-Nobrega M. A Randomized Controlled Trial of a Digital Stepped-Care Program to Reduce Anxiety and Depressive Symptoms Among Long-Term Care Workers With Psychological Distress: The REPICAL Study. Depress Anxiety. 2026 Oct 2;2026:5875889. doi: 10.1155/da/5875889. eCollection 2026.
PubMed 42829513
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities
- ClinicalTrials.gov ID
- NCT05526235
- Acronym / sponsor ID
- REPICAL / 202114
- Conditions
- Depression, Anxiety, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, Universidad Autonoma de Madrid
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Sep 2022 (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 current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters [DWM] and Problem Management Plus [PM+]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19 pandemic.
Detailed description
Background: The COVID-19 pandemic has impacted the mental health of long-term care workers (LTCWs). This study combines two low-intensity psychological interventions developed by the World Health Organization (Doing What Matters [DWM] and Problem Management Plus [PM+]) into a stepped-care program for LTCWs.
Objective: To evaluate the implementation of a stepped-care program (DWM; PM+) amongst LTCWs following changes in care due to the COVID-19 pandemic in terms of mental distress, resilience and wellbeing.
Study design: A randomized controlled implementation trial with a single-blinded, parallel-group design.
Study population: Long-term care workers (including workers of assisted living facilities and home care) with self-reported elevated psychological distress.
Intervention-study: All participants (in both the treatment and the comparison group) will receive Psychological First Aid (PFA) and care as usual (CAU). In addition to PFA and CAU, the treatment group will receive the stepped-care intervention (DWM with or without PM+). The stepped-care intervention consists of DWM (step 1) and conditionally PM+ (step 2) if participants still meet criteria for psychological distress (Kessler Psychological Distress scale (K10) >15.9) 1 month after having received DWM.
Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered through phone calls. All assessments will be online and will take place at baseline, 2 weeks after having received DWM, 1 week after having received PM+ and 2 months after PM+. The main study parameter will be the decrease of anxiety and depressive symptoms from baseline to two-month follow-up, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped-care program (Step 1: DWM; Step 2: PM+) | Experimental | Behavioral: Doing What Matters (DWM), Behavioral: Problem Management Plus (PM+), Behavioral: Psychological First Aid (PFA)The treatment group will first receive Psychological First Aid (PFA). PFA consists of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources. Afterwards participants will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2). Step 2 will only be provided if the participant still has elevated levels of psychological distress (i.e. during the second quantitative assessment at 2 weeks after DWM). Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Interventions: Behavioral: Doing What Matters (DWM) Behavioral: Problem Management Plus (PM+) Behavioral: Psychological First Aid (PFA) |
| Psychological First Aid (PFA) | Active comparator | Behavioral: Psychological First Aid (PFA)Participants allocated to the control arm will also receive PFA. Participants will also be allowed to continue with their mental health interventions (CAU), as long as they meet eligibility criteria. Intervention: Behavioral: Psychological First Aid (PFA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older;
- Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).
- Written/digital informed consent before entering the study.
- Being a worker in a long-term care facility or a home care worker in the community of Catalonia.
Key exclusion criteria (6 listed)
- Having acute medical conditions (requiring hospitalization)
- Imminent suicide risk, or expressed acute needs, or protection risks that require immediate follow-up
- Having a severe mental disorder (e.g., psychotic disorders, substance-dependence)
- Having severe cognitive impairment (e.g., severe intellectual disability or dementia)
- Currently specialized psychological treatment (e.g., Eye movement desensitization and reprocessing, Cognitive behavioral therapy)
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 |
|---|---|---|
| Doing What Matters (DWM)Also: Doing What Matters in Times of Stress, Self Help Plus, DWM, SH+The original DWM program consists of a self-help guide called 'Doing What Matters in Times of Stress', that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. In this study, DWM will be delivered as an online intervention. The DWM intervention, i.e. both the audio recordings and the self-help guide, has been adapted for use on a smartphone or other device with internet access. The format of DWM is innovative in that it seeks to ensure that key intervention components are delivered as intended through the use of pre-recorded audio, without the burden of extensive training and supervision. In the online application tool a new module is released every week so participants will be asked to go through the entire DWM intervention within 5 weeks with weekly guidance from a helper. | Behavioural | Stepped-care program (Step 1: DWM; Step 2: PM+) |
| Problem Management Plus (PM+)Also: PM+PM+ is a new, brief, psychological intervention program based on cognitive behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support. Across the five 90-minute sessions participants may talk to trained non-professional. PM+ has four core features, and it is brief. In this study, the delivery mode of the PM+ intervention will be flexible, with remote delivery in phases of the pandemic when physical distancing rules apply. This is a future-oriented attempt towards a more holistic mental health care system that can flexibly switch between modes of delivery (e.g. remotely (e.g. Zoom) or face-to), depending on the needs and the specific containment measures that apply, and the specific preferences and needs of the participant. | Behavioural | Stepped-care program (Step 1: DWM; Step 2: PM+) |
| Psychological First Aid (PFA)Also: PFAPFA is a brief intervention consisting of a 15-min call that assess the immediate concerns and needs of an individual in order to connect individuals to help and resources. | Behavioural | Psychological First Aid (PFA), Stepped-care program (Step 1: DWM; Step 2: PM+) |
Primary outcome
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time frame: Change from baseline to 20 weeks
The PHQ-ADS is a 16-item self-reported instrument that combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale-as a composite measure of depression and anxiety. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
6 secondary outcomes
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time frame: Change: Baseline, 6 weeks, and 12 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 6 weeks, 12 weeks, and 20 weeks
Generalized Anxiety Disorder (GAD-7) scale
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - 8-item version
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)
Time frame: Baseline, 6 weeks, 12 weeks, and 20 weeks
Client Service Receipt Inventory (CSRI) - adaptation
Time frame: Change: Baseline, 6 weeks, 12 weeks, and 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 42829513Gonzalez-Spinoglio L, Esplugues-Tormo M, Gine-Vazquez I, Rodeiro-Boliart J, Aguilar-Ortiz S, Ayuso-Mateos JL, McGreevy KR, Mediavilla R, Roos R, Sijbrandij M, Witteveen AB, Haro JM, Felez-Nobrega M. A Randomized Controlled Trial of a Digital Stepped-Care Program to Reduce Anxiety and Depressive Symptoms Among Long-Term Care Workers With Psychological Distress: The REPICAL Study. Depress Anxiety. 2026 Oct 2;2026:5875889. doi: 10.1155/da/5875889. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Josep Maria Haro, MD,PhD principal investigator
Fundació Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doing What Matters (DWM), Problem Management Plus (PM+) and Psychological First Aid (PFA) in people with Depression and Anxiety, run by Fundació Sant Joan de Déu 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 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mireia Felez-Nobrega, PhD (936406350 ext. 12540, mireia.felez@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) (time frame: Change from baseline to 20 weeks). 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 NCT05526235, 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 26 Apr 2024.