Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 324
- 试验地点
- 8
- 主要终点
- Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003)
研究概览
简要总结
This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).
详细描述
This study is a multi-country randomized controlled trial (RCT) with three groups comparing efficacy of unguided Internet-based intervention for students low on resilience with three conditions: a) unguided web-based resilience intervention (CORE); 2) Healthy lifestyle psychoeducationalprogram (HLP); and 3) Care as usual condition (CAU). Online- and telephone assessments will be conducted at pre- and post-intervention, and at 6- and 12-month follow-up (see Figure 1). Participants will be randomized in a 1:1 ratio. Randomization will be stratified according to trial site.
The aim of this trial is to evaluate the efficiency and effectiveness of an Internet-based programme developed to promote resilience and coping skills among at-risk university students in Spain, Argentina and Mexico. The specific aims are:
- To provide a preventative online intervention for enhancing resilience for decreasing symptoms of depression and anxiety and for increasing wellbeing
- To evaluate the effectiveness and acceptability of CORE program in a randomized controlled trial compared with two conditions, Healthy lifestyle (HTP) and care as usual (CAU).
- To analyze feasible strategies to implement CORE and to identify possible implementation barriers from final users, professionals of University counseling services and the University authorities in three Spanish-speaking countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •University students with a standard deviation score below the sample mean on the Connor-Davidson Resilience Scale (CDRISC-25).
- •Adequate knowledge to understand and read Spanish and/or be Spanish-speaking.
- •Internet access and computer skills.
排除标准
- •University students who are on a waiting list for psychotherapy or who are or have been undergoing psychotherapy in the last 12 months.
- •Individuals with a current or past psychotic or bipolar disorder.
- •Individuals at risk of suicide.
研究组 & 干预措施
CORE condition
CORE is a 6-week web-based prevention programme whose main objective is to teach coping skills and strategies to cope with stressful everyday situations in order to improve resilience, promote self-efficacy and increase well-being. The intervention consists of 6 interactive modules designed for weekly sessions and organized in 6 dimensions: autonomy, self-acceptance, environmental mastery, purpose in life, positive relationships, and personal growth. Each module includes exercises to practice the proposed skills. The program includes multimedia elements: videos, audios, vignettes, images.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Healthy lifestyle
This program will provide information to promote a healthy lifestyle, on issues related to physical and mental health and physical activity, as well as diet and sleep management. The components of psychoeducation are based on the intervention protocol for depression (Castro, et al. 2015) based on low intensity psychological intervention models for mild or moderate depressive symptoms in primary care (Garcia-Herrera et al 2011; NICE, 2009; Nieuwsma et al 2012).
干预措施: Healthy lifestyle (Behavioral)
Waiting List Control
Participants assigned to the Waiting List control group will be evaluated and monitored at the start of the study, 4 weeks, 8 weeks and follow-ups at 3 months. After the last follow-up evaluation, they will be given access to CORE training.
结局指标
主要结局
Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003)
时间窗: Up to 3 months
Assesses stress coping skills using a 25-item self-report questionnaire that use a 5-point Likert scale from 0 to 4 (0 = strongly disagree, 4 = strongly agree). Scores range from 0 to 100, with higher scores reflecting greater resilience. Score from pre-intervention to post-intervention and 3 months follow-ups.
次要结局
- The Ryff Scales of Psychological Well-Being - 29 items (PWBS-29; Ryff, 1989)(Up to 3 months)
- The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)(Up to 3 months)
- Responses to Positive Affect questionnaire (RPA; Feldman et al., 2008)(Up to 3 months)
- Positive and Negative Effects Program (PANAS) (Watson et al., 1988)(Up to 3 months)
- The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006)(Up to 3 months)
- The Perceived Stress Scale - 4 items (PSS-4; Cohen et al., 1983)(Up to 3 months)
- Self-compassion Scale - Short Form (SCS-SF; Raes et al., 2011)(Up to 3 months)
- 10-Item Big Five Inventory (BFI-10; Rammstedt and John, 2007)(Up to 4 weeks)
- The Credibility and Expectancy Questionnaire (CEQ; Devilly and Borkovec, 2000)(Up to 4 weeks)
- Client Satisfaction Questionnaire (CSQ; Attkisson and Greenfield, 1996; Larsen et al., 1979)(Up to 8 weeks)
- Working Alliance Inventory for Technology Based Interventions (WAI-TECH; Kiluk et al., 2014)(Up to 8 weeks)
- Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al. 2006)(Up to 8 weeks)
- Overall Depression Severity and Impairment Scale (ODSIS; Bentley, et. Al 2014).(Up to 8 weeks)
- Openness to the future Scale (OF)(Botella et a.l, 2018 )(Up to 3 months)