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

Universitat Jaume I

Status: Unknown

Conditions: Waiting List Control; CORE Condition; Healthy Lifestyle Psychoeducational Program

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Healthy lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT03903978

Labpsitec_CORE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

324 participants in 3 patient groups

CORE condition

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Healthy lifestyle

Active Comparator group

Description:

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).

Treatment:

Behavioral: Healthy lifestyle

Waiting List Control

No Intervention group

Description:

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.