Cognitive Resilience Intervention as a Recovery Therapy for Mental Health (CRI)

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.

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Behavioral: Cognitive Resilience Intervention

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rotimi Oguntayo, Mphil; Phone Number: +526567781832; Email: al228170@alumnos.uacj.mx
• Study Contact Backup: Name: Marisela Gutiérrez-Vega; Phone Number: +526562152075; Email: marisela.gutierrez@uacj.mx

Study Locations

• Mexico
  • Chihuahua
    • Juarez, Chihuahua, Mexico, 32340
      • SUAPSI
      • Contact: Francisco Calderon, PhD; Phone Number: +526566384847; Email: francisco.calderon@uacj.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: three one-arm trials (N = 4-6/trial); 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.

Behavioral: Cognitive Resilience Intervention; 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; Other Names: CRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire for assessing the satisfaction on therapy received	The Client Satisfaction Questionnaire has a 4-point response range from "1" for low satisfaction to "4" for high satisfaction. The scale scores range from 0 to 32 points; a score of 6 or greater is suggestive of client satisfaction with therapy outcomes; higher scores indicate greater satisfaction.	4minutes
The Competence Scale for Psychoeducation for Facilitator Competency	The Competence Scale for Psychoeducation used a 7-point rating scale (0=poor, 1=barely adequate, 2=mediocre, 3=satisfactory, 4=good, 5=very good, and 6=excellent). The score for therapists' competence is 31 and above; a higher score indicates a greater level of competence.	4 minutes

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Ciudad Juarez
• Investigators: Principal Investigator: Rotimi Oguntayo, Mphil, Universidad Autonoma de Ciudad Juarez; Study Chair: Verónica Portillo-Reyes, PhD, Universidad Autonoma de Ciudad Juarez; Study Chair: Gerardo Ochoa Meza, PhD, Universidad Autonoma de Ciudad Juarez; Study Director: Marisela Gutiérrez-Vega, PhD, Universidad Autonoma de Ciudad Juarez

Study record dates

Study Major Dates

• Study Start (Estimated): February 13, 2024
• Primary Completion (Estimated): August 13, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: "Anxiety"; "Cognitive Resilience"; "Depression"; "Intervention Development"; "suicidal Ideations"; "Students"
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: CEI-2023-1-63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will make available the procedure for collecting data at the pre-test, intervention, and post-test levels.
• IPD Sharing Time Frame: 2023-2024
• IPD Sharing Access Criteria: The manuscript and the published copy will be made available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No