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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The Plutchik Suicide Risk Scale for suicidal risk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The Plutchik Suicide Risk Scale for suicidal risk
时间窗: 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
时间窗: 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.
次要结局
- The General Anxiety Disorder-2 is for measuring general anxiety(1 minute)
- The Patient Health Questionnaire for depression(1 minute)