NCT03903978

Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in College Students

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Universitat Jaume I · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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: 1. To provide a preventative online intervention for enhancing resilience for decreasing symptoms of depression and anxiety and for increasing wellbeing 2. 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). 3. 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.

Conditions

• CORE Condition
• Healthy Lifestyle Psychoeducational Program
• Waiting List Control

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	The training protocol consists of 6 weekly modules: 0.Welcome:Introduction module to the program, with an explanation about the tools and the way to use CORE 1. Psychoeducation: Explanation of psychological wellbeing and the concept of resilience 2. Autonomy, building my way: Enhancement of autonomy 3. Mindfulness and self-compassion:Training in mindfulness, savoring, and an attitude of self-compassion 4. Overcoming obstacles: Development of coping strategies to deal with daily difficulties in life 5. Connecting to others:Acknowledge the relevance of relationships and how they can be helpful in the construction of well-being 6. Purpose in life and personal growth:Approach the future with a positive attitude, planning goals for the future.
BEHAVIORAL	Healthy lifestyle	1. Beginning of a lifestyle change The patient will learn to identify healthy and risky behaviors and recognize obstacles that prevent them from adopting a healthy lifestyle. 2. Physical activity The importance of "moving on" and activating behavior will be taught through regular exercise information to improve mood. 3. Diet This module is dedicated to teaching the importance of diet for good physical and mental health. The Mediterranean diet will be taken as an example for a balanced and balanced diet, because it does not differ from the habits of other countries. 4. Sleep The importance of good sleep will be addressed with information and strategies for understanding the relationship between sleep and overall health.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-11-01
• Completion: 2020-11-01
• First posted: 2019-04-04
• Last updated: 2019-04-04

Locations

5 sites across 3 countries: Argentina, Mexico, Spain