Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in College Students
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|ClinicalTrials.gov Identifier: NCT03903978|
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|CORE Condition Healthy Lifestyle Psychoeducational Program Waiting List Control||Behavioral: Cognitive Behavioral Therapy Behavioral: Healthy lifestyle||Not Applicable|
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:
- To provide a preventative online intervention for enhancing resilience for decreasing symptoms of depression and anxiety and for increasing wellbeing
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2020|
Experimental: CORE condition
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
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
Active Comparator: Healthy lifestyle
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
No Intervention: Waiting List Control
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.
- Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) [ Time Frame: Up to 3 months ]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.
- The Ryff Scales of Psychological Well-Being - 29 items (PWBS-29; Ryff, 1989) [ Time Frame: Up to 3 months ]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.
- The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) [ Time Frame: Up to 3 months ]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.
- Responses to Positive Affect questionnaire (RPA; Feldman et al., 2008) [ Time Frame: Up to 3 months ]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.
- Positive and Negative Effects Program (PANAS) (Watson et al., 1988) [ Time Frame: Up to 3 months ]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.
- The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) [ Time Frame: Up to 3 months ]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.
- The Perceived Stress Scale - 4 items (PSS-4; Cohen et al., 1983) [ Time Frame: Up to 3 months ]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.
- Self-compassion Scale - Short Form (SCS-SF; Raes et al., 2011) [ Time Frame: Up to 3 months ]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.
- 10-Item Big Five Inventory (BFI-10; Rammstedt and John, 2007) [ Time Frame: Up to 4 weeks ]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
- The Credibility and Expectancy Questionnaire (CEQ; Devilly and Borkovec, 2000) [ Time Frame: Up to 4 weeks ]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
- Client Satisfaction Questionnaire (CSQ; Attkisson and Greenfield, 1996; Larsen et al., 1979) [ Time Frame: Up to 8 weeks ]
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
- Working Alliance Inventory for Technology Based Interventions (WAI-TECH; Kiluk et al., 2014) [ Time Frame: Up to 8 weeks ]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
- Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al. 2006) [ Time Frame: Up to 8 weeks ]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
- Overall Depression Severity and Impairment Scale (ODSIS; Bentley, et. Al 2014). [ Time Frame: Up to 8 weeks ]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
- Openness to the future Scale (OF)(Botella et a.l, 2018 ) [ Time Frame: Up to 3 months ]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.
- Socio-demographic data [ Time Frame: Up to 4 weeks ]Measurements of sociodemographic variables are included: sex, household size and income, age, marital status, employment status, total population of the place of residence, nationality, level of education and living situation. In addition, health-related variables will be measured: presence of psychological disorders (past and present) and whether treatment is currently being carried out. Score from pre-intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903978
|Universidad de Mar del Plata|
|Mar Del Plata, Buenos Aires, Argentina|
|Universidad de Buenos Aires|
|Buenos Aires, Argentina, 1053|
|Universidad Autónoma del Estado de Hidalgo|
|Pachuca, Hidalgo, Mexico, 42039|
|Univesity Jaume I|
|Castelló de la Plana, Castellon, Spain, 12071|
|Universitat de Valencia|
|Study Director:||Cristina Botella, PhD||University Jaume I, Castellon, Spain|
|Principal Investigator:||Araceli Palma Gómez, Phd Student||University Jaume I, Castellon, Spain|
|Principal Investigator:||Rocio Herrero, PhD||University Jaume I, Castellon, Spain|