Clinical trial NCT06123442: Cognitive Resilience Intervention as a Recovery Therapy for Mental Health
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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"
Lead sponsor: Universidad Autonoma de Ciudad Juarez
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Plutchik Suicide Risk Scale for suicidal risk
timeFrame: 5minutes
measure: Brief Resilience Scale for assessing resilient behavior
timeFrame: 1 minute
Secondary outcomes:
measure: The General Anxiety Disorder-2 is for measuring general anxiety
timeFrame: 1 minute
measure: The Patient Health Questionnaire for depression
timeFrame: 1 minute
Other outcomes:
measure: Client Satisfaction Questionnaire for assessing the satisfaction on therapy received
timeFrame: 4minutes
measure: The Competence Scale for Psychoeducation for Facilitator Competency
timeFrame: 4 minutes
Locations:
city: Juarez
country: Mexico
facility: SUAPSI
state: Chihuahua
Study officials:
affiliation: Universidad Autonoma de Ciudad Juarez
name: Rotimi Oguntayo, Mphil
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma de Ciudad Juarez
name: Verónica Portillo-Reyes, PhD
role: STUDY_CHAIR
affiliation: Universidad Autonoma de Ciudad Juarez
name: Gerardo Ochoa Meza, PhD
role: STUDY_CHAIR
affiliation: Universidad Autonoma de Ciudad Juarez
name: Marisela Gutiérrez-Vega, PhD
role: STUDY_DIRECTOR
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