Reduction in Mental Health and Suicide Are the Focus of InterestCRINCT06123442
Cognitive Resilience Intervention as a Recovery Therapy for Mental Health
A study testing Cognitive Resilience Intervention in people with Reduction in Mental Health and Suicide Are the Focus of Interest and Four Assessment Time Points Would be Used to Monitor Participants Through a Laid Down Conditions, run by Universidad Autonoma de Ciudad Juarez at 1 site in Mexico.
Trial summary
The goal of this randomized controlled trial (RCT) is to develop and test a cognitive resilience intervention (CRI) among selected students who are having problems with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and to see if it can help lower PDSE among… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reduction in Mental Health and Suicide Are the Focus of Interest, Four Assessment Time Points Would be Used to Monitor Participants Through a Laid Down Conditions
- What is being tested?
- Cognitive Resilience Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 13 Feb 2024to 1 Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least 18 years old
- He or she is current students of UACJ and residence in the Juárez city
- As determined by the mental health treatment provider, sufficient clinical stability and suitability for group therapy.
- Adequate medical stability as determined by a medical professional.
- Imminent history or risk of mental health and suicidal (that is, suicide attempt) or homicidal behavior.
- Suicidal episode within the past weeks (determined by the PSRS inclusion criteria items).
- Scoring 1 above the cut off scores of PSRS, GAD-2, PHQ-2 and scoring low on the BRS
Who cannot join
- Inability to perform CRI tasks based on their performance on a sample reading and writing task from the manual (given during screening)
- Non-Spanish speaking students
- Lack of capacity to consent or sign the informed consent
- Unable to attend outpatient group treatment program
- Participation in another CRI intervention
Trial locations and contacts
1 site in 1 country.
Mexico1 site
SUAPSI
Juárez, Chihuahua, 32340
Francisco Calderon, PhD, +526566384847, francisco.calderon@uacj.mx
About this study
Official title: Feasibility and Acceptability of Cognitive Resilience Intervention as a Recovery Therapy for Mental Health Among University Students: A Study Protocol for a Randomized Controlled Clinical Trial
The goal of this randomized controlled trial (RCT) is to develop and test a cognitive resilience intervention (CRI) among selected students who are having problems with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and to see if it can help lower PDSE among the students who were enrolled. This study will assess the feasibility and acceptability of a CRI among students dealing with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and determine if it is effective at reducing PDSE among the sampled students using psychological assessment tools. Participants will be exposed to CRI in the experimental group and psychoeducation in the control group. Researchers will compare the experimental group with the control group and infer the difference between these groups both at the pretest and posttest phases, as well as ascertain the feasibility and acceptability of this therapy among selected participants.
Read the detailed description
In a bid to assess the feasibility and acceptability of Cognitive Resilience Intervention (CRI) in students with Persistent Distressing Suicidal Ideation (PDSE), this two-year pilot study is designed as an open-label exploration. The study comprises three individual trials, each involving a single group, followed by a pilot randomized controlled trial (RCT) with both experimental and control groups. This research, carried out at the University Psychological Care Services (SUAPSI) of the Autonomous University of Ciudad Juárez, Chihuahua, Mexico, aims to gather data utilizing a pretest-posttest approach.
Participants for the trials and pilot RCT will be recruited through advertisements on the UACJ and SUAPSI websites, as well as through the distribution of flyers. To ensure eligibility, pre-screening and verification of institutional affiliation will be conducted. All participants will be required to provide informed consent before their participation. Clinical assessments, including the Plutchik Suicide Risk Scale (PSRS), General Anxiety Disorder-2 (GAD-2), Patient Health Questionnaire-2 (PHQ-2), and the Brief Resilience Scale (BRS), will be utilized to evaluate participants' eligibility and characteristics. If potential participants do not respond after pre-screening, multiple contact attempts will be made before their participation is terminated.
To ensure equitable distribution of participants across age and gender categories, a restricted randomization method will be employed, dividing participants into three cohorts. A total of 19 participants will be evenly divided between the two groups using randomized block calculations. This approach is aimed at mitigating potential attrition risks and ensuring the desired sample size for the CRI one-arm trials. It is a commonly used method in small RCTs to maintain unbiased selection and comparability between control and treatment groups.
The inclusion and exclusion criteria for the one-arm trials and pilot RCT are the same, although the criteria for the pilot RCT may be adjusted based on lessons learned from the one-arm trials. The primary outcome measures of this study are focused on assessing personal recovery from suicidal ideation and risk factors, with four assessment time points throughout the one-year PDSE period. The Plutchik Suicide Risk Scale (PSRS) and Brief Resilience Scale (BRS) are used to evaluate these outcomes.
Additionally, secondary outcome measures include the General Anxiety Disorder-2 (GAD-2), which assesses core anxiety symptoms. The CRI group, consisting of 19 participants, will meet weekly over 12 weeks, facilitated by the researcher and co-doctorate student colleagues. Qualitative data will be collected from participants and facilitators after each session.
A pilot RCT will be conducted using treatment materials refined through the one-arm trials. Participants and SUAPSI authority will be informed of the readiness for the pilot RCT. Participants will be recruited following the guidelines mentioned in Section 2.2.
In the pilot RCT, participants will be randomly assigned to treatment conditions, while the research assistant conducting assessments will remain blind to these conditions. This study encompasses university students from various levels and programs who meet the criteria outlined in Table 1.2. The process for characterizing participants will mirror the approach used in the one-arm trials, with adjustments based on lessons learned during their execution.
- Conditions
- Reduction in Mental Health and Suicide Are the Focus of Interest, Four Assessment Time Points Would be Used to Monitor Participants Through a Laid Down Conditions
- Being tested
- Cognitive Resilience Intervention
- Keywords
- "Anxiety", "Cognitive Resilience", "Depression", "Intervention Development", "suicidal Ideations", "Students"
- Medical subject headings
- Anxiety Disorders, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Resilience InterventionBehavioural
Also called CRI
Participants will have 12 weeks to complete the program, and then before the post-assessment, there will be a one-month feedback period [22]. This includes twelve components: 1) preliminary routine, 2) significance of knowing yourself, 3) interpreting events and stressors, 4) taking autonomy over events, 5) practicing mindfulness and self-compassion, 6) learning adaptation skills, 7) building connection , 8) purpose in life and personal growth, 9) Regulation and disclosure of emotions, 10) practicing gratitude, and 11) positive Communication both intra and interpersonal, 12) overcoming obstacles and moving forward (in the context of current problems) and the conclusion/retrospection are addressed in 12 sessions while closure and post assessment will be done after a month
| Study group | Role | What they receive |
|---|---|---|
| three one-arm trials (N = 4-6/trial) | Experimental | This research protocol entails three one-arm trials and a pilot RCT with 58 participants. Its primary aim is to develop the Cognitive Resilience Intervention (CRI) and assess its feasibility and acceptability. Student feedback and data on feasibility and acceptability will be collected before and after each trial to fine-tune the intervention using empirical guidance. CRI aims to help participants lead more meaningful lives, emphasizing purpose, autonomy, and the pursuit of goals while avoiding suicidal ideation. In contrast, the comparator RCT's control group will undergo General Psychoeducation (GPE), a structured program focusing on enhancing mental health awareness through psychology psycho-education sessions. Receives: Behavioral: Cognitive Resilience Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Plutchik Suicide Risk Scale for suicidal risk
The Plutchik Suicide Risk Scale to measure suicidal ideation; a score of 6 or more indicate the presence of suicidal risk
Measured: 5minutes
Brief Resilience Scale for assessing resilient behavior
The Brief Resilience Scale measures resilience; the scale is a five-point Likert scale ranging from strongly disagree (1) to strongly agree (5). The addition of value (1-5) responses for the 6-item scale range from 6-30. For the final score, responses are divided by the total number of questions answered. Scores are interpreted as follows: Low resilience (1.00-2.99), Normal resilience (3.00-4.30), and High resilience (4.31-5.00). High scores indicate resilience.
Measured: 1 minute
Secondary outcomes (2)
The General Anxiety Disorder-2 is for measuring general anxiety
The General Anxiety Disorder-2 is scored by assigning 0, 1, 2, and 3 for each response category and adding them together. The score ranges from 0 to 6, and scores of 0-2 indicate mild anxiety, but scores of 3 and above indicate generalized anxiety disorder symptoms.
Measured: 1 minute
The Patient Health Questionnaire for depression
The Patient Health Questionnaire for measuring depression is scored by assigning 0, 1, 2, and 3 for each response category and adding them together. The score ranges from 0 to 6, and scores of 0-2 indicate mild depression; a score of 3 or greater is considered positive for depression
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start13 Feb 2024 (estimated)
- Primary completion13 Aug 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction in Mental Health and Suicide Are the Focus of InterestStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This open-label, 2-year pilot study seeks to determine the feasibility and acceptability of CRI in students with psychological distress comorbid with suicide behavior. This study will employ three single-arm trials followed by a pilot randomized controlled trial with an experimental and control group. This university-based research will use a pretest-posttest design to collect data
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Ciudad Juarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rotimi Oguntayo, Mphil, Principal investigator, Universidad Autonoma de Ciudad JuarezVerónica Portillo-Reyes, PhD, Study chair, Universidad Autonoma de Ciudad JuarezGerardo Ochoa Meza, PhD, Study chair, Universidad Autonoma de Ciudad JuarezMarisela Gutiérrez-Vega, PhD, Study director, Universidad Autonoma de Ciudad Juarez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123442
- Sponsor's protocol ID
- CEI-2023-1-63
- Acronym
- CRI
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will make available the procedure for collecting data at the pre-test, intervention, and post-test levels.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Cognitive Resilience Intervention as a Recovery Therapy for Mental Health Among University Students: A Study Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06123442
- Acronym / sponsor ID
- CRI / CEI-2023-1-63
- Conditions
- Reduction in Mental Health and Suicide Are the Focus of Interest, Four Assessment Time Points Would be Used to Monitor Participants Through a Laid Down Conditions
- Keywords
- "Anxiety", "Cognitive Resilience", "Depression", "Intervention Development", "suicidal Ideations", "Students"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Ciudad JuarezUniversity, hospital or other
- Study start
- 13 Feb 2024 (estimated)
- Primary completion
- 13 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 8 Nov 2023 (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 goal of this randomized controlled trial (RCT) is to develop and test a cognitive resilience intervention (CRI) among selected students who are having problems with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and to see if it can help lower PDSE among the students who were enrolled. This study will assess the feasibility and acceptability of a CRI among students dealing with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and determine if it is effective at reducing PDSE among the sampled students using psychological assessment tools. Participants will be exposed to CRI in the experimental group and psychoeducation in the control group. Researchers will compare the experimental group with the control group and infer the difference between these groups both at the pretest and posttest phases, as well as ascertain the feasibility and acceptability of this therapy among selected participants.
Detailed description
In a bid to assess the feasibility and acceptability of Cognitive Resilience Intervention (CRI) in students with Persistent Distressing Suicidal Ideation (PDSE), this two-year pilot study is designed as an open-label exploration. The study comprises three individual trials, each involving a single group, followed by a pilot randomized controlled trial (RCT) with both experimental and control groups. This research, carried out at the University Psychological Care Services (SUAPSI) of the Autonomous University of Ciudad Juárez, Chihuahua, Mexico, aims to gather data utilizing a pretest-posttest approach.
Participants for the trials and pilot RCT will be recruited through advertisements on the UACJ and SUAPSI websites, as well as through the distribution of flyers. To ensure eligibility, pre-screening and verification of institutional affiliation will be conducted. All participants will be required to provide informed consent before their participation. Clinical assessments, including the Plutchik Suicide Risk Scale (PSRS), General Anxiety Disorder-2 (GAD-2), Patient Health Questionnaire-2 (PHQ-2), and the Brief Resilience Scale (BRS), will be utilized to evaluate participants' eligibility and characteristics. If potential participants do not respond after pre-screening, multiple contact attempts will be made before their participation is terminated.
To ensure equitable distribution of participants across age and gender categories, a restricted randomization method will be employed, dividing participants into three cohorts. A total of 19 participants will be evenly divided between the two groups using randomized block calculations. This approach is aimed at mitigating potential attrition risks and ensuring the desired sample size for the CRI one-arm trials. It is a commonly used method in small RCTs to maintain unbiased selection and comparability between control and treatment groups.
The inclusion and exclusion criteria for the one-arm trials and pilot RCT are the same, although the criteria for the pilot RCT may be adjusted based on lessons learned from the one-arm trials. The primary outcome measures of this study are focused on assessing personal recovery from suicidal ideation and risk factors, with four assessment time points throughout the one-year PDSE period. The Plutchik Suicide Risk Scale (PSRS) and Brief Resilience Scale (BRS) are used to evaluate these outcomes.
Additionally, secondary outcome measures include the General Anxiety Disorder-2 (GAD-2), which assesses core anxiety symptoms. The CRI group, consisting of 19 participants, will meet weekly over 12 weeks, facilitated by the researcher and co-doctorate student colleagues. Qualitative data will be collected from participants and facilitators after each session.
A pilot RCT will be conducted using treatment materials refined through the one-arm trials. Participants and SUAPSI authority will be informed of the readiness for the pilot RCT. Participants will be recruited following the guidelines mentioned in Section 2.2.
In the pilot RCT, participants will be randomly assigned to treatment conditions, while the research assistant conducting assessments will remain blind to these conditions. This study encompasses university students from various levels and programs who meet the criteria outlined in Table 1.2. The process for characterizing participants will mirror the approach used in the one-arm trials, with adjustments based on lessons learned during their execution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This open-label, 2-year pilot study seeks to determine the feasibility and acceptability of CRI in students with psychological distress comorbid with suicide behavior. This study will employ three single-arm trials followed by a pilot randomized controlled trial with an experimental and control group. This university-based research will use a pretest-posttest design to collect data
| Arm | Type | Receives |
|---|---|---|
| three one-arm trials (N = 4-6/trial) | Experimental | Behavioral: Cognitive Resilience InterventionThis research protocol entails three one-arm trials and a pilot RCT with 58 participants. Its primary aim is to develop the Cognitive Resilience Intervention (CRI) and assess its feasibility and acceptability. Student feedback and data on feasibility and acceptability will be collected before and after each trial to fine-tune the intervention using empirical guidance. CRI aims to help participants lead more meaningful lives, emphasizing purpose, autonomy, and the pursuit of goals while avoiding suicidal ideation. In contrast, the comparator RCT's control group will undergo General Psychoeducation (GPE), a structured program focusing on enhancing mental health awareness through psychology psycho-education sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- At least 18 years old
- He or she is current students of UACJ and residence in the Juárez city
- As determined by the mental health treatment provider, sufficient clinical stability and suitability for group therapy.
- Adequate medical stability as determined by a medical professional.
- Imminent history or risk of mental health and suicidal (that is, suicide attempt) or homicidal behavior.
Key exclusion criteria (5 listed)
- Inability to perform CRI tasks based on their performance on a sample reading and writing task from the manual (given during screening)
- Non-Spanish speaking students
- Lack of capacity to consent or sign the informed consent
- Unable to attend outpatient group treatment program
- Participation in another CRI intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Resilience InterventionAlso: CRIParticipants will have 12 weeks to complete the program, and then before the post-assessment, there will be a one-month feedback period [22]. This includes twelve components: 1) preliminary routine, 2) significance of knowing yourself, 3) interpreting events and stressors, 4) taking autonomy over events, 5) practicing mindfulness and self-compassion, 6) learning adaptation skills, 7) building connection , 8) purpose in life and personal growth, 9) Regulation and disclosure of emotions, 10) practicing gratitude, and 11) positive Communication both intra and interpersonal, 12) overcoming obstacles and moving forward (in the context of current problems) and the conclusion/retrospection are addressed in 12 sessions while closure and post assessment will be done after a month | Behavioural | three one-arm trials (N = 4-6/trial) |
Primary outcome
The Plutchik Suicide Risk Scale for suicidal risk
Time frame: 5minutes
The Plutchik Suicide Risk Scale to measure suicidal ideation; a score of 6 or more indicate the presence of suicidal risk
Brief Resilience Scale for assessing resilient behavior
Time frame: 1 minute
The Brief Resilience Scale measures resilience; the scale is a five-point Likert scale ranging from strongly disagree (1) to strongly agree (5). The addition of value (1-5) responses for the 6-item scale range from 6-30. For the final score, responses are divided by the total number of questions answered. Scores are interpreted as follows: Low resilience (1.00-2.99), Normal resilience (3.00-4.30), and High resilience (4.31-5.00). High scores indicate resilience.
2 secondary outcomes
The General Anxiety Disorder-2 is for measuring general anxiety
Time frame: 1 minute
The Patient Health Questionnaire for depression
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Yes. The study will make available the procedure for collecting data at the pre-test, intervention, and post-test levels.
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.
Rotimi Oguntayo, Mphil principal investigator
Universidad Autonoma de Ciudad Juarez
Verónica Portillo-Reyes, PhD study chair
Universidad Autonoma de Ciudad Juarez
Gerardo Ochoa Meza, PhD study chair
Universidad Autonoma de Ciudad Juarez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Resilience Intervention in people with Reduction in Mental Health and Suicide Are the Focus of Interest and Four Assessment Time Points Would be Used to Monitor Participants Through a Laid Down Conditions, run by Universidad Autonoma de Ciudad Juarez at 1 site in Mexico.
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 7 inclusion and 5 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 14 Nov 2023. 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 Mexico. 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 Rotimi Oguntayo, Mphil (+526567781832, al228170@alumnos.uacj.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Plutchik Suicide Risk Scale for suicidal risk (time frame: 5minutes). The study lists 2 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 14 Nov 2023.