Clinical trial NCT03903978: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in College Students
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CORE Condition
Healthy Lifestyle Psychoeducational Program
Waiting List Control
Keywords: Resilience
University students
Prevention
Online intervention
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003)
timeFrame: Up to 3 months
Secondary outcomes:
measure: The Ryff Scales of Psychological Well-Being - 29 items (PWBS-29; Ryff, 1989)
timeFrame: Up to 3 months
measure: The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
timeFrame: Up to 3 months
measure: Responses to Positive Affect questionnaire (RPA; Feldman et al., 2008)
timeFrame: Up to 3 months
measure: Positive and Negative Effects Program (PANAS) (Watson et al., 1988)
timeFrame: Up to 3 months
measure: The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006)
timeFrame: Up to 3 months
measure: The Perceived Stress Scale - 4 items (PSS-4; Cohen et al., 1983)
timeFrame: Up to 3 months
measure: Self-compassion Scale - Short Form (SCS-SF; Raes et al., 2011)
timeFrame: Up to 3 months
measure: 10-Item Big Five Inventory (BFI-10; Rammstedt and John, 2007)
timeFrame: Up to 4 weeks
measure: The Credibility and Expectancy Questionnaire (CEQ; Devilly and Borkovec, 2000)
timeFrame: Up to 4 weeks
measure: Client Satisfaction Questionnaire (CSQ; Attkisson and Greenfield, 1996; Larsen et al., 1979)
timeFrame: Up to 8 weeks
measure: Working Alliance Inventory for Technology Based Interventions (WAI-TECH; Kiluk et al., 2014)
timeFrame: Up to 8 weeks
measure: Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al. 2006)
timeFrame: Up to 8 weeks
measure: Overall Depression Severity and Impairment Scale (ODSIS; Bentley, et. Al 2014).
timeFrame: Up to 8 weeks
measure: Openness to the future Scale (OF)(Botella et a.l, 2018 )
timeFrame: Up to 3 months
Other outcomes:
measure: Socio-demographic data
timeFrame: Up to 4 weeks
Locations:
city: Mar Del Plata
country: Argentina
facility: Universidad de Mar del Plata
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Universidad de Buenos Aires
city: Pachuca
country: Mexico
facility: Universidad Autónoma del Estado de Hidalgo
state: Hidalgo
city: Castelló de la Plana
country: Spain
facility: Univesity Jaume I
state: Castellon
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
affiliation: University Jaume I, Castellon, Spain
name: Cristina Botella, PhD
role: STUDY_DIRECTOR
affiliation: University Jaume I, Castellon, Spain
name: Araceli Palma Gómez, Phd Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jaume I, Castellon, Spain
name: Rocio Herrero, PhD
role: PRINCIPAL_INVESTIGATOR
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