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

NCT03903978 | Unknown DMC

• 1 other identifier: Labpsitec_CORE
• Study Type: interventional
• Target: 324
• Locations: 3 countries
• Sites: 5

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).

Conditions

CORE Condition; Healthy Lifestyle Psychoeducational Program; Waiting List Control

Keywords

Resilience; University students; Prevention; Online intervention

Outcome Measures

Primary Outcomes (1)

• Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003)

  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.

  Up to 3 months

Secondary Outcomes (14)

• 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

Other Outcomes (1)

• Socio-demographic data

  Up to 4 weeks

Study Arms (3)

CORE condition

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy

Healthy lifestyle

ACTIVE COMPARATOR

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).

Behavioral: Healthy lifestyle

Waiting List Control

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

CORE condition

Healthy lifestyle BEHAVIORAL

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.

Healthy lifestyle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (5)

Universidad de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Location

Universidad de Buenos Aires

Buenos Aires, 1053, Argentina

Location

Universidad Autónoma del Estado de Hidalgo

Pachuca, Hidalgo, 42039, Mexico

Location

Univesity Jaume I

Castellon, Castellon, 12071, Spain

Location

Universitat de Valencia

Valencia, Spain

Location

Related Publications (12)

• Banos RM, Etchemendy E, Mira A, Riva G, Gaggioli A, Botella C. Online Positive Interventions to Promote Well-being and Resilience in the Adolescent Population: A Narrative Review. Front Psychiatry. 2017 Jan 30;8:10. doi: 10.3389/fpsyt.2017.00010. eCollection 2017.

  PMID: 28194117 BACKGROUND

• Cuijpers P, Cristea IA, Ebert DD, Koot HM, Auerbach RP, Bruffaerts R, Kessler RC. PSYCHOLOGICAL TREATMENT OF DEPRESSION IN COLLEGE STUDENTS: A METAANALYSIS. Depress Anxiety. 2016 May;33(5):400-14. doi: 10.1002/da.22461. Epub 2015 Dec 18.

  PMID: 26682536 BACKGROUND

• Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.

  PMID: 24281296 BACKGROUND

• Salamanca-Sanabria A, Richards D, Timulak L, Castro-Camacho L, Mojica-Perilla M, Parra-Villa Y. Assessing the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for depression: protocol for a randomised controlled trial. BMC Psychiatry. 2018 Feb 27;18(1):53. doi: 10.1186/s12888-018-1634-x.

  PMID: 29482586 BACKGROUND

• Leppin AL, Bora PR, Tilburt JC, Gionfriddo MR, Zeballos-Palacios C, Dulohery MM, Sood A, Erwin PJ, Brito JP, Boehmer KR, Montori VM. The efficacy of resiliency training programs: a systematic review and meta-analysis of randomized trials. PLoS One. 2014 Oct 27;9(10):e111420. doi: 10.1371/journal.pone.0111420. eCollection 2014.

  PMID: 25347713 BACKGROUND

• Dray J, Bowman J, Campbell E, Freund M, Hodder R, Wolfenden L, Richards J, Leane C, Green S, Lecathelinais C, Oldmeadow C, Attia J, Gillham K, Wiggers J. Effectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents. J Adolesc. 2017 Jun;57:74-89. doi: 10.1016/j.adolescence.2017.03.009. Epub 2017 Apr 3.

  PMID: 28384523 BACKGROUND

• Ebert DD, Zarski AC, Christensen H, Stikkelbroek Y, Cuijpers P, Berking M, Riper H. Internet and computer-based cognitive behavioral therapy for anxiety and depression in youth: a meta-analysis of randomized controlled outcome trials. PLoS One. 2015 Mar 18;10(3):e0119895. doi: 10.1371/journal.pone.0119895. eCollection 2015.

  PMID: 25786025 BACKGROUND

• Ibrahim AK, Kelly SJ, Adams CE, Glazebrook C. A systematic review of studies of depression prevalence in university students. J Psychiatr Res. 2013 Mar;47(3):391-400. doi: 10.1016/j.jpsychires.2012.11.015. Epub 2012 Dec 20.

  PMID: 23260171 BACKGROUND

• Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.

  PMID: 23639300 BACKGROUND

• Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.

  PMID: 22209829 BACKGROUND

• Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.

  PMID: 32691879 DERIVED

• Palma-Gomez A, Herrero R, Banos R, Garcia-Palacios A, Castaneiras C, Fernandez GL, Llull DM, Torres LC, Barranco LA, Cardenas-Gomez L, Botella C. Efficacy of a self-applied online program to promote resilience and coping skills in university students in four Spanish-speaking countries: study protocol for a randomized controlled trial. BMC Psychiatry. 2020 Apr 5;20(1):148. doi: 10.1186/s12888-020-02536-w.

  PMID: 32248795 DERIVED

Related Links

• Psychology and Technology is a platform that contains treatment programs for different mental and physical health problems, which can be applied according to the specific needs of each person, step by step, and adapting to the pace of the user, from home

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cristina Botella, PhD

  University Jaume I, Castellon, Spain

  STUDY DIRECTOR

• Araceli Palma Gómez, Phd Student

  University Jaume I, Castellon, Spain

  PRINCIPAL INVESTIGATOR

• Rocio Herrero, PhD

  University Jaume I, Castellon, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: April 4, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); AR (2); ME (1)