Mental Health CareMH-CPR CaSNCT07219264
Mental Health CPR for Cancer Survivors
A study testing Mental Health CPR and Standard Community Health Education in people with Mental Health Care and Mental Health, run by Ponce Medical School Foundation, Inc. at 1 site in Puerto Rico.
Trial summary
This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Care, Mental Health, Depression Anxiety Disorder
- What is being tested?
- Mental Health CPR and Standard Community Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 26 Sep 2025to 31 Aug 2028
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility Criteria for Sub-Aim 1a. The eligibility criteria for the qualitative interviews will be 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer care community organization representatives, clinical care providers of cancer patients and survivors, and cancer health educators; 3: self-identified as a Latino/Hispanic; 4: be able to complete an interview.
- Eligibility Criteria for Aim 2. Community Forums stakeholders eligibility criteria. The community stakeholders inclusion criteria for the community forum are 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer patients/survivors, cancer patients/survivors identified family caregiver, healthcare providers, cancer supportive care organizations, and advocacy groups, 3: self-identified as a Latino/Hispanic, 4: be able to attend the community forums.
- Community Leaders Eligibility Criteria for CMHW training. The inclusion criteria for the community leaders to be trained as CMHW are 1: Participants over 21 years of age, 2: living in a limited resource community in southern Puerto Rico, 3: self-identified as a Latino/Hispanic, and 4: be able to provide support to H-CAPS through their role as CMHW.
- Communities Eligibility Criteria. Community municipalities included from the southern health region of Puerto Rico are: Ponce, Arroyo, Coamo, Yauco, Salinas, Guanica, Guayanilla, Juana Diaz, Adjuntas, Guayama, Patillas, Santa Isabel, Penuelas and Villalba. These municipalities were chosen because they represent the catchment area of Ponce Health Sciences University.
- Also, they are comprised of mostly rural areas (south-central region of Puerto Rico) and present a higher incidence of cancer (south region) and cancer mortality (south-central region) compared to other Puerto Rican Health regions.
- Intervention eligibility criteria. The eligibility criteria for the community intervention are 1: Participants over 21 years old, 2: living in any of the municipalities of the southern health region of Puerto Rico and within a limited resource community according to the CDC SVI, 3: self-identified as a Latino/Hispanic, and 4: have had a cancer diagnosis during their adulthood.
Who cannot join
- Participants residing outside the catchment area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site, 1 recruiting
- Recruiting
Ponce Medical School Foundation, Inc.
Ponce, Puerto Rico, 00732
Jean M Torres Vazquez, ENG, 787-840-2575 ext. 4793, jmtorres@psm.edu
Eida M Castro-Figueroa, PsyD, MSc
About this study
Official title: Mental Health CPR: Transforming Cancer Survivors' Mental Health With Community Participatory Reach
This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico.
The main questions it aims to answer are:
Read more
- Does Mental Health CPR help more people complete psychological distress screening?
- Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels.
Participants will:
- Attend community sessions led by trained Community Mental Health Workers (CMHWs)
- Receive printed materials and educational resources
- Take part in brief follow-ups over about 36 weeks
Read the detailed description
Mental Health CPR is a community-based behavioral intervention designed to improve access to psycho-oncology care and promote psychological well-being among Hispanic/Latino cancer survivors in Puerto Rico. The program was developed through a community-engaged process to ensure cultural and linguistic appropriateness and sustainability.
The study employs a cluster randomized parallel design in which community clusters are assigned to one of two conditions: the Mental Health CPR intervention or a standard community health education program. Trained Community Mental Health Workers (CMHWs) implement both arms concurrently over a 36-week period.
The Mental Health CPR intervention includes:
- Multimedia community sessions addressing emotional health and coping after cancer;
- Printed educational materials on distress screening and mental health resources; and
- Follow-up to reinforce key messages and promote connection to psycho-oncology services.
The comparison attention control group will be invited to attend general health fairs in which mental health printed educational materials will be available along with distress screening assessment.
Primary outcomes include completion of distress screening and uptake of psycho-oncology services. Secondary outcomes assess emotional distress, patient-caregiver communication, attitudes toward mental health care, quality of life, resilience, and selected salivary biomarkers related to stress and inflammation.
The study's findings will inform future strategies to enhance access to psycho-oncology services, strengthen the capacity of community-based health workers, and promote mental health care among cancer survivors living in under-supported communities.
- Being tested
- Mental Health CPR, Standard Community Health Education
- Keywords
- Mental Health, Distress, Depression, Anxiety
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health CPRBehavioural
The Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed.
Standard Community Health EducationBehavioural
The control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health CPR Intervention | Experimental | Participants in this arm will receive the Mental Health PR community-based behavioral intervention. The program consist pf structured sections facilitated by trained Community Mental Health Workers (CHMWs) focused on improving communication, stress management, and access to mental health services. Sessions are delivered in small groups through culturally tailored materials and multimedia tools. Receives: Behavioral: Mental Health CPR |
| Standard Community Health Education | Active comparator | Participants in this arm receive standard community health education about mental health and wellness, without the structured Mental Health CPR behavioral components. This comparator arm allows for the evaluation of the added benefit of the Mental Health CPR intervention beyond general health education. Due to ethical considerations, the community-led intervention will be offered to the control arm after the community-intervention arm is completed. Participants in this arm will receive standard community health education materials about mental health and wellness, without the Mental Health CPR behavioral training components. This serves as the comparison group to evaluate the effectiveness of the intervention. Receives: Behavioral: Standard Community Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of the Community Toolbox for the Mental Health CPR Intervention
This outcome reflects the successful design, adaptation, and completion of the Community Toolbox - a culturally and linguistically tailored set of multimedia and printed resources developed to support the implementation of the Mental Health CPR intervention by Community Mental Health Workers (CMHWs). The Toolbox integrates educational modules, testimonial videos, infographics, and text message templates addressing distress screening, stigma reduction, communication enhancement, and linkage to psycho-oncology services. Completion is defined as finalization of all Toolbox modules validated through expert and community stakeholder review under Specific Aim 1.
Measured: 18 months
Distress Thermometer (DT)
The Distress Thermometer (DT) is a validated single-item visual analog screening tool developed by the National Comprehensive Cancer Network (NCCN) to measure psychological distress in cancer patients. Participants rate their distress over the past week on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater emotional distress. Mean DT score (0-10 scale)
Measured: 9 months
Psych-oncology mental health service referral uptake
The percentage of participants who, after being screened for psychological distress, accept and complete at least one referral to psycho-oncology or behavioral health services. Uptake will be defined as documented attendance at one or more sessions with a licensed mental health or psycho-oncology provider. Data will be collected through Community Mental Health Worker (CMHW) tracking logs and verified by participant follow-up. Higher percentages indicate greater engagement in mental health services following the intervention.
Measured: 9 months
Secondary outcomes (9)
Communication and Caregiving Assessment Tool (Patient Form - CCAT-PF)
The Communication and Caregiving Assessment Tool - Patient Form (CCAT-PF) is a validated self-report scale that assesses the quality and effectiveness of communication between patients and their primary caregivers. The scale includes items rated on a Likert-type format to evaluate understanding, emotional support, and problem-solving aspects of the patient-caregiver relationship. Higher scores indicate better communication quality. Mean score on the CCAT-PF (range 1-5)
Measured: 9 months
Communication and Caregiving Assessment Tool (Caregiver Form - CCAT-CF)
The Communication and Caregiving Assessment Tool - Patient Form (CCAT-PF) is a validated self-report instrument that measures the patient's perception of communication quality with their primary caregiver. Items are rated on a Likert-type scale assessing emotional support, understanding, and collaborative problem solving. Higher scores indicate better communication quality. Mean CCAT-PF total score (range 1-5)
Measured: 9months
Self-Stigma of Mental Illness Scale (SSMIS)
The Self-Stigma of Mental Illness Scale (SSMIS), developed by Corrigan et al. (2006), is a validated 40-item self-report instrument that measures internalized stigma toward mental illness and help-seeking. The SSMIS assesses four sequential components of self-stigma: awareness of stereotypes, agreement with stereotypes, application of stereotypes to oneself, and harm to self-esteem. Items are rated on a 9-point Likert scale (1 = strongly disagree to 9 = strongly agree). Higher scores indicate greater self-stigma. Mean SSMIS total score (range 1-9)
Measured: 9 months
Psychological distress, assessed with the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS), is a validated 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in medical and community populations. It consists of two subscales-HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D)-each containing 7 items scored from 0 to 3. Subscale scores range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity. Mean HADS-A and HADS-D subscale scores (range 0-21)
Measured: 9 months
Health-Related Quality of Life assessed with the Functional Assessment of Cancer Therapy - General (FACT-G, Version 4)
The Functional Assessment of Cancer Therapy - General (FACT-G, Version 4) is a validated 27-item questionnaire developed by Cella et al. (1993) that measures health-related quality of life in cancer patients across four domains: Physical, Social/Family, Emotional, and Functional Well-Being. Each item is rated on a 5-point Likert-type scale (0-4). Higher scores indicate better quality of life.
Population: Adult cancer survivors enrolled in the Mental Health CPR study. Unit of Measure: Mean FACT-G total score (range 0-108)
Measured: 9 months
Perceived Social Support, asses with Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS), developed by Zimet et al. (1988), is a validated 12-item self-report questionnaire that measures perceived social support from three sources: family, friends, and significant others. Each item is rated on a 7-point Likert scale (1 = very strongly disagree to 7 = very strongly agree). Higher total scores indicate greater perceived social support. Mean MSPSS total score (range 1-7)
Measured: 9 months
Brief Resilience Scale (BRS)
The Brief Resilience Scale (BRS), developed by Smith et al. (2008), is a 6-item self-report questionnaire designed to assess the ability to recover from stress. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores reflect greater resilience. Mean BRS total score (range 1-5)
Measured: 9 months
Salivary Stress Hormone Levels (Cortisol and Alpha-Amylase)
Salivary cortisol and alpha-amylase levels will be measured as biomarkers of physiological stress response. Saliva samples will be collected from participants at baseline and post-intervention following standardized collection procedures (e.g., morning fasting samples). Samples will be stored and analyzed in a blinded laboratory setting using enzyme-linked immunosorbent assay (ELISA) and kinetic enzyme assays. Higher cortisol and alpha-amylase concentrations indicate higher physiological stress activation. Laboratory personnel conducting assays are blinded to participants' group assignments. Mean salivary cortisol (µg/dL); mean salivary alpha-amylase (U/mL)
Measured: 9 months
Salivary Cytokine and Chemokine Concentrations
Salivary cytokine and chemokine concentrations will be analyzed as biomarkers of inflammation and immune activation associated with stress response. Samples will be collected using standardized saliva collection procedures and stored at -80°C until analysis. Laboratory assays will be performed using multiplex immunoassay or enzyme-linked immunosorbent assay (ELISA) methods to quantify cytokines (e.g., IL-6, IL-10, TNF-α) and chemokines (e.g., MCP-1, IL-8). All laboratory personnel conducting the analyses are blinded to participants' group assignments to ensure unbiased outcome assessment. Higher concentrations reflect greater inflammatory response. Mean concentration (pg/mL)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start26 Sep 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester, University of Puerto Rico Medical Sciences Campus
- Responsible party
- Principal investigator, Eida M Castro-Figueroa, Ponce Medical School Foundation, Inc.
- Investigators
- Eida M Castro-Figuera, PsyD, MSc, Principal investigator, Ponce Medical School Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219264
- Sponsor's protocol ID
- U01CA290613
- Acronym
- MH-CPR CaS
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2025
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data, data dictionary, and supporting documentation will be deposited in a Trans-NIH BMIC-approved generalist repository following publication of the primary results. Data will be curated under FAIR principles and protected under a Certificate of Confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health CPR: Transforming Cancer Survivors' Mental Health With Community Participatory Reach
- ClinicalTrials.gov ID
- NCT07219264
- Acronym / sponsor ID
- MH-CPR CaS / U01CA290613
- Keywords
- Mental Health, Distress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester, University of Puerto Rico Medical Sciences Campus
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Oct 2025 (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 is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico.
The main questions it aims to answer are:
- Does Mental Health CPR help more people complete psychological distress screening?
- Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels.
Participants will:
- Attend community sessions led by trained Community Mental Health Workers (CMHWs)
- Receive printed materials and educational resources
- Take part in brief follow-ups over about 36 weeks
Detailed description
Mental Health CPR is a community-based behavioral intervention designed to improve access to psycho-oncology care and promote psychological well-being among Hispanic/Latino cancer survivors in Puerto Rico. The program was developed through a community-engaged process to ensure cultural and linguistic appropriateness and sustainability.
The study employs a cluster randomized parallel design in which community clusters are assigned to one of two conditions: the Mental Health CPR intervention or a standard community health education program. Trained Community Mental Health Workers (CMHWs) implement both arms concurrently over a 36-week period.
The Mental Health CPR intervention includes:
- Multimedia community sessions addressing emotional health and coping after cancer;
- Printed educational materials on distress screening and mental health resources; and
- Follow-up to reinforce key messages and promote connection to psycho-oncology services.
The comparison attention control group will be invited to attend general health fairs in which mental health printed educational materials will be available along with distress screening assessment.
Primary outcomes include completion of distress screening and uptake of psycho-oncology services. Secondary outcomes assess emotional distress, patient-caregiver communication, attitudes toward mental health care, quality of life, resilience, and selected salivary biomarkers related to stress and inflammation.
The study's findings will inform future strategies to enhance access to psycho-oncology services, strengthen the capacity of community-based health workers, and promote mental health care among cancer survivors living in under-supported communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health CPR Intervention | Experimental | Behavioral: Mental Health CPRParticipants in this arm will receive the Mental Health PR community-based behavioral intervention. The program consist pf structured sections facilitated by trained Community Mental Health Workers (CHMWs) focused on improving communication, stress management, and access to mental health services. Sessions are delivered in small groups through culturally tailored materials and multimedia tools. |
| Standard Community Health Education | Active comparator | Behavioral: Standard Community Health EducationParticipants in this arm receive standard community health education about mental health and wellness, without the structured Mental Health CPR behavioral components. This comparator arm allows for the evaluation of the added benefit of the Mental Health CPR intervention beyond general health education. Due to ethical considerations, the community-led intervention will be offered to the control arm after the community-intervention arm is completed. Participants in this arm will receive standard community health education materials about mental health and wellness, without the Mental Health CPR behavioral training components. This serves as the comparison group to evaluate the effectiveness of the intervention. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligibility Criteria for Sub-Aim 1a. The eligibility criteria for the qualitative interviews will be 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer care community organization representatives, clinical care providers of cancer patients and survivors, and cancer health educators; 3: self-identified as a Latino/Hispanic; 4: be able to complete an interview.
- Eligibility Criteria for Aim 2. Community Forums stakeholders eligibility criteria. The community stakeholders inclusion criteria for the community forum are 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer patients/survivors, cancer patients/survivors identified family caregiver, healthcare providers, cancer supportive care organizations, and advocacy groups, 3: self-identified as a Latino/Hispanic, 4: be able to attend the community forums.
- Community Leaders Eligibility Criteria for CMHW training. The inclusion criteria for the community leaders to be trained as CMHW are 1: Participants over 21 years of age, 2: living in a limited resource community in southern Puerto Rico, 3: self-identified as a Latino/Hispanic, and 4: be able to provide support to H-CAPS through their role as CMHW.
- Communities Eligibility Criteria. Community municipalities included from the southern health region of Puerto Rico are: Ponce, Arroyo, Coamo, Yauco, Salinas, Guanica, Guayanilla, Juana Diaz, Adjuntas, Guayama, Patillas, Santa Isabel, Penuelas and Villalba. These municipalities were chosen because they represent the catchment area of Ponce Health Sciences University.
- Also, they are comprised of mostly rural areas (south-central region of Puerto Rico) and present a higher incidence of cancer (south region) and cancer mortality (south-central region) compared to other Puerto Rican Health regions.
Key exclusion criteria (1 listed)
- Participants residing outside the catchment area.
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 |
|---|---|---|
| Mental Health CPRThe Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed. | Behavioural | Mental Health CPR Intervention |
| Standard Community Health EducationThe control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions. | Behavioural | Standard Community Health Education |
Primary outcome
Development of the Community Toolbox for the Mental Health CPR Intervention
Time frame: 18 months
This outcome reflects the successful design, adaptation, and completion of the Community Toolbox - a culturally and linguistically tailored set of multimedia and printed resources developed to support the implementation of the Mental Health CPR intervention by Community Mental Health Workers (CMHWs). The Toolbox integrates educational modules, testimonial videos, infographics, and text message templates addressing distress screening, stigma reduction, communication enhancement, and linkage to psycho-oncology services. Completion is defined as finalization of all Toolbox modules validated through expert and community stakeholder review under Specific Aim 1.
Distress Thermometer (DT)
Time frame: 9 months
The Distress Thermometer (DT) is a validated single-item visual analog screening tool developed by the National Comprehensive Cancer Network (NCCN) to measure psychological distress in cancer patients. Participants rate their distress over the past week on a scale from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater emotional distress. Mean DT score (0-10 scale)
Psych-oncology mental health service referral uptake
Time frame: 9 months
The percentage of participants who, after being screened for psychological distress, accept and complete at least one referral to psycho-oncology or behavioral health services. Uptake will be defined as documented attendance at one or more sessions with a licensed mental health or psycho-oncology provider. Data will be collected through Community Mental Health Worker (CMHW) tracking logs and verified by participant follow-up. Higher percentages indicate greater engagement in mental health services following the intervention.
9 secondary outcomes
Communication and Caregiving Assessment Tool (Patient Form - CCAT-PF)
Time frame: 9 months
Communication and Caregiving Assessment Tool (Caregiver Form - CCAT-CF)
Time frame: 9months
Self-Stigma of Mental Illness Scale (SSMIS)
Time frame: 9 months
Psychological distress, assessed with the Hospital Anxiety and Depression Scale (HADS)
Time frame: 9 months
Health-Related Quality of Life assessed with the Functional Assessment of Cancer Therapy - General (FACT-G, Version 4)
Time frame: 9 months
Perceived Social Support, asses with Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 9 months
Brief Resilience Scale (BRS)
Time frame: 9 months
Salivary Stress Hormone Levels (Cortisol and Alpha-Amylase)
Time frame: 9 months
Salivary Cytokine and Chemokine Concentrations
Time frame: 9 months
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 21 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified participant-level data, data dictionary, and supporting documentation will be deposited in a Trans-NIH BMIC-approved generalist repository following publication of the primary results. Data will be curated under FAIR principles and protected under a Certificate of Confidentiality.
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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.
Eida M Castro-Figuera, PsyD, MSc principal investigator
Ponce Medical School Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health CPR and Standard Community Health Education in people with Mental Health Care and Mental Health, run by Ponce Medical School Foundation, Inc. at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 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: looking for participants now, as of the sponsor's last update on 21 Oct 2025. 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 Puerto Rico. 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 Eida M Castro-Figueroa, PsyD, MSc (787-840-2575 ext. 2166, ecastro@psm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of the Community Toolbox for the Mental Health CPR Intervention (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2025.