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CORE ConditionNCT03903978

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

A study testing Cognitive Behavioral Therapy and Healthy lifestyle in people with CORE Condition and Healthy Lifestyle Psychoeducational Program, run by Universitat Jaume I at 5 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Cognitive Behavioral Therapy and Healthy lifestyle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
5 sitesin 3 countries
Study dates
1 Nov 2018to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Argentina2 sites

  • Universidad de Buenos Aires

    Buenos Aires, 1053

  • Universidad de Mar del Plata

    Mar del Plata, Buenos Aires

Other trials in Argentina

Spain2 sites

  • Univesity Jaume I

    Castellon, Castellon, 12071

  • Universitat de Valencia

    Valencia

Other trials in Spain

Mexico1 site

  • Universidad Autónoma del Estado de Hidalgo

    Pachuca, Hidalgo, 42039

Other trials in Mexico

About this study

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

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).

Read the 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.
Being tested
Cognitive Behavioral Therapy, Healthy lifestyle
Keywords
Resilience, University students, Prevention, Online intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    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.

  • Healthy lifestyleBehavioural

    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.
Study groups in NCT03903978
Study groupRoleWhat they receive
CORE conditionExperimentalCORE 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.
Receives: Behavioral: Cognitive Behavioral Therapy
Healthy lifestyleActive comparatorThis 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).
Receives: Behavioral: Healthy lifestyle
Waiting List ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 months

Secondary outcomes (14)

  1. The Ryff Scales of Psychological Well-Being - 29 items (PWBS-29; Ryff, 1989)

    Is an instrument for measuring the faces of psychological well-being, including the 6 dimensions of the Ryff model (autonomy, self-acceptance, mastery of the environment, personal growth, positive relationships with others and purpose in life). Response scores range from 1 to 6 (1 = strongly disagree, 6 = strongly agree). Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  2. The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)

    Is a questionnaire to examine and diagnose patients with depressive disorders, consisting of 9 items measured on a scale of 0 to 3 (0 = not at all, 3 = almost every day). Total scores range from 0 to 27. The severity cut-off points for depression are 5, 10, 15 and 20 and represent respectively the thresholds for mild, moderate, moderately severe and severe depression. Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  3. Responses to Positive Affect questionnaire (RPA; Feldman et al., 2008)

    is a questionnaire that assesses the responses to positive affective states and consists of 17 items. Items are rated on a 4-point scale, ranging from 1 (almost never) to 4 (almost always). The original measure consists of three factor-analytically derived subscales: Dampening, Self-focused positive rumination, and Emotion-focused positive rumination.

    Measured: Up to 3 months

  4. Positive and Negative Effects Program (PANAS) (Watson et al., 1988)

    PANAS evaluates two independent dimensions: positive affect (PANAS+) and negative affect (PANAS-). It consists of 20 items divided into 10 range items for each dimension is from 10 to 50. Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  5. The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006)

    Is used to detect the presence of the symptoms of Generalized Anxiety Disorder (GAD) according to DSM-IV. It is a one-dimensional self-administered scale and although it does not provide a definitive diagnosis of GAD, it is an efficient, fast to apply, reliable and valid instrument for detecting symptoms of an anxiety disorder. The scoring scale is 0 to 3 (0 = nothing, 3 = almost every day), adding up to 0 to 21 points. They are four severity cut-off points (minimum = 0 to 4, mild = 5 to 9, moderate = 10 to 14, serious = 14 to 20) and represent the minimum to severe general anxiety thresholds. Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  6. The Perceived Stress Scale - 4 items (PSS-4; Cohen et al., 1983)

    Assess the extent to which recent life situations are considered stressful (Cohen et al., 1983) using a 4-item self-report questionnaire. It is a Likert scale from 1 to 5 (1 = never, 5 = very often). PSS-4 is a short version that has been used for telephone interviews or study conditions requiring short versions. Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  7. Self-compassion Scale - Short Form (SCS-SF; Raes et al., 2011)

    is designed to assess general self-compassion (total score) and 3 facets of this construct: common humanity (SCSCH), mindfulness (SCS-M), and self-kindness (SCS-SK) (Raes et al., 2011). This version is shorter than the original version of 26-item SCS (Neff, 2003). It contains 6 subscales representing positive and negative aspects of each facet (Raes et al., 2011). A 5-point Likert-type scale is used, ranging from 1 to 5 (1 = almost never, 5 = almost always). Score from pre-intervention to post-intervention and 3 months follow-ups.

    Measured: Up to 3 months

  8. 10-Item Big Five Inventory (BFI-10; Rammstedt and John, 2007)

    was developed to provide a personality inventory for research environments with extreme time constraints. This questionnaire is an abridged version of the 44-item BFI. This is a 5-step scale from 1 to 5 (1 = strongly disagree, 5 = strongly agree). Score pre-intervention

    Measured: Up to 4 weeks

  9. The Credibility and Expectancy Questionnaire (CEQ; Devilly and Borkovec, 2000)

    evaluates factors of patient expectations and credibility about the treatment. This self-report consists of 6 items with answer choices rated on a 10-point scale and on a scale of 1-100%. Score pre-intervention

    Measured: Up to 4 weeks

  10. Client Satisfaction Questionnaire (CSQ; Attkisson and Greenfield, 1996; Larsen et al., 1979)

    The Client Satisfaction Questionnaire (CSQ) assesses the level of client satisfaction with health services. There are several versions of the CSQ, the longest version contains 31 items and the shortest has 8 items. The questionnaire is based on 8 questions that must be answered at the end of their stay in the service on the basis of an analogovisual scale. Each question is evaluated between 1 and 4 points and satisfaction is directly related to the number of points, so that the sum of place to a semi-quantitative variable that takes values between 8 and 32 points. The response scale is:

    csq_q1: 4=Excellent; 3=Good; 2= Regular; 1= Bad csq_q2: 1= No, definitely; 2= In very few cases; 3= Yes in general; 4=Yes definitely csq_q3: 4=Almost all; 3=Most; 2=Only a few; 1=None csq_q4: 1=No definitely; 2=No, I don't think so; 3= Yes, I think so; 4= Yes, definitely csq_q5: 1=Nothing satisfied; 2= Indifferent or moderately unsatisfied; 3=Moderately satisfied; 4=Very satisfied csq_q6: 4=If

    Measured: Up to 8 weeks

  11. Working Alliance Inventory for Technology Based Interventions (WAI-TECH; Kiluk et al., 2014)

    is a questionnaire that evaluates the therapeutic alliance between the technological tool and the patient. It covers two dimensions of the working alliance: (1) therapeutic objectives and (2) tasks. It consists of 8 items on a 5-point Likert scale from 1 to 5 (1 = never, 5 = always). Score from post-treatment

    Measured: Up to 8 weeks

  12. Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al. 2006)

    It is a 5-item questionnaire, with a score of 0 to 4, that evaluates the frequency and severity of anxiety symptoms. The instrument also provides measures related to anxiety symptoms such as avoidance, work, academy, social and daily life disabilities. According to a psychometric analysis it has good internal consistency (α =.80), test-test reliability (k =.82) and convergent validity. Score from pre-intervention to post-intervention

    Measured: Up to 8 weeks

  13. Overall Depression Severity and Impairment Scale (ODSIS; Bentley, et. Al 2014).

    It is a self-report measure with five items that assess experiences related to depression, measuring its frequency and severity, as well as the level of avoidance behaviors, interference between work, school and home, and associated social. The internal consistency of the scale has proven to be excellent, with a Cronbach alpha between 0.91 and 0.94 and good convergent and discriminant validity. Score from pre-intervention to post-intervention

    Measured: Up to 8 weeks

  14. Openness to the future Scale (OF)(Botella et a.l, 2018 )

    It is a scale consisting of 10 items of scores ranging from 1 to 5 on a likert scale and assesses expectations and positive affectivity towards the future, which includes five domains: (1) Illusion of control (2) Acceptance (3) Commitment to life and planning (4) Positive orientation towards the future (5) Self-efficacy towards the future.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start1 Nov 2018
  3. Primary completion1 Nov 2019 (estimated)
  4. Study completion1 Nov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903978
Sponsor's protocol ID
Labpsitec_CORE
Status last verified
Apr 2019
First submitted
18 Sep 2018
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28194117

  • 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.

    PubMed 26682536

  • 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.

    PubMed 24281296

  • 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.

    PubMed 29482586

  • 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.

    PubMed 25347713

  • 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.

    PubMed 28384523

  • 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.

    PubMed 25786025

  • 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.

    PubMed 23260171

  • 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.

    PubMed 23639300

  • 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.

    PubMed 22209829

  • 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.

    PubMed 32691879

  • 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.

    PubMed 32248795

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy and Healthy lifestyle in people with CORE Condition and Healthy Lifestyle Psychoeducational Program, run by Universitat Jaume I at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Argentina, Spain, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903978, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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