Cognitive Resilience Intervention as a Recovery Therapy for Mental Health

NCT06123442 | Unknown DMC

• 1 other identifier: CEI-2023-1-63
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

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"

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The General Anxiety Disorder-2 is for measuring general anxiety

  1 minute

• The Patient Health Questionnaire for depression

  1 minute

Other Outcomes (2)

• Client Satisfaction Questionnaire for assessing the satisfaction on therapy received

  4minutes

• The Competence Scale for Psychoeducation for Facilitator Competency

  4 minutes

Study Arms (1)

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.

Behavioral: Cognitive Resilience Intervention

Interventions

Cognitive Resilience Intervention BEHAVIORAL

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

Also known as: CRI

three one-arm trials (N = 4-6/trial)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: All gender identities are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Scoring 1 above the cut off scores of PSRS, GAD-2, PHQ-2 and scoring low on the BRS

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Ciudad Juarez: lead

Study Sites (1)

SUAPSI

Juárez, Chihuahua, 32340, Mexico

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• Rotimi Oguntayo, Mphil

  Universidad Autonoma de Ciudad Juarez

  PRINCIPAL INVESTIGATOR

• Verónica Portillo-Reyes, PhD

  Universidad Autonoma de Ciudad Juarez

  STUDY CHAIR

• Gerardo Ochoa Meza, PhD

  Universidad Autonoma de Ciudad Juarez

  STUDY CHAIR

• Marisela Gutiérrez-Vega, PhD

  Universidad Autonoma de Ciudad Juarez

  STUDY DIRECTOR

Central Study Contacts

Rotimi Oguntayo, Mphil

CONTACT

+526567781832; al228170@alumnos.uacj.mx

Marisela Gutiérrez-Vega

CONTACT

+526562152075; marisela.gutierrez@uacj.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: After enrolling participants and conducting baseline assessments, individuals will be randomly assigned to one of two treatment conditions using a 1:1 allocation ratio following the guidelines already laid down guidelines. It's worth noting that this study will involve university students from various levels and programs, as long as they meet the criteria outlined in Table 1.2. While the facilitators will be aware of the treatment conditions, the research assistant responsible for conducting assessments after randomization will remain blind to these conditions. The process of characterizing the participants will follow the same approach as the three one-arm trials, with any necessary adjustments made based on lessons learned during the trial groups' execution.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 8, 2023
• Study Start: February 13, 2024
• Primary Completion: August 13, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2023-2024
• Access Criteria: The manuscript and the published copy will be made available upon reasonable request.

Locations

ME (1)