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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04129892
Other study ID # Tel Hai
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 3, 2019
Est. completion date December 1, 2021

Study information

Verified date June 2021
Source Tel Hai College
Contact Maya Mouallem, M.Sc
Phone +972524285382
Email smayal@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The course " In Favor of My Resilient Self" will guide participants to develop their strength sources, as well as practice self-calming and self-controlling exercises. The main goals of the course are to: 1. Measure the effects on the emotional resilience and confidence of participants. 2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies. 3. Understand the mechanisms of the effects. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course.


Description:

The online Bachelor's degree course " In Favor of My Resilient Self" provides updated information regarding the term 'emotional resilience' and its mediating factors. Through weekly lessons and assignments, it will guide participants to developing an internal perspective on their strength sources, as well as practice self-calming and self-controlling exercises. The main goals of the course are to: 1. Measure the effects on the emotional resilience and confidence of participants. 2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies. 3. Understand the mechanisms of the effects. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. All participants, in the intervention (course participants) and in the control group (students of both faculties that didn't attend the course), received information about the program and the study and were asked to provide informed consent.


Recruitment information / eligibility

Status Recruiting
Enrollment 322
Est. completion date December 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Students at Tel Hai College that are interested in participating in the study, and provided informed consent. Exclusion Criteria: - Students that did not provide informed consent to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
"In Favor of My Resilient Self" Academic course
Assessing the effect of an academic course on student's emotional resilience.

Locations

Country Name City State
Israel Tel Hai Academic College Kiryat Shmona North Of Israel

Sponsors (1)

Lead Sponsor Collaborator
Tel Hai College

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC) The CD-RISC is based on Connor and Davidson's operational definition of resilience, which is the ability to "thrive in the face of adversity." The scale includes 25 items, from 5 sub-scales:
Personal competence, high standards, and tenacity
Trust in one's instincts, tolerance of negative affect, and strengthening effects of stress
Positive acceptance of change and secure relationships
Control
Spiritual influences Scoring: Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is therefore from 0 to 100, with higher scores reflecting greater resilience. (Connor KM, Davidson JRT. Depression and Anxiety 2003; 18: 71-82).
Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
Secondary Change from Baseline in Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4R) The Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4) is a measure of internalization of appearance ideals (i.e., personal acceptance of societal ideals) and appearance pressures (i.e., pressures to achieve the societal ideal). We included 22 items from the subscales: (1) Internalization: Thin/Low Body Fat, (2) Internalization: Muscular, (3) Internalization: General Attractiveness, (4) Pressures: Media, (5) Pressures: Peers, and (6) Pressures: Significant Others. (Schaefer et al, 2017) Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
Secondary Change from Baseline in Rosenberg Self-Esteem Scale (RSE) Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items. Scoring involves a method of combined ratings. Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
Secondary Change from Baseline in Depression, Anxiety and Stress Scale (DASS-21) Depression, Anxiety and Stress Scale - 21 Items (DASS-21) The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
Secondary Change from Baseline in Body Esteem Scale (BES) Body Esteem Scale- This questionnaire examines self-esteem of body and physical appearance and consists of 3 subscales: appearance (10 items), weight (8 items) and attribution 187 to others (5 items). Items are rated on a 5-point scale: (1) never, (2) rarely, (3) sometimes, (4) 188 often, and (5) always. A higher score indicates higher body-esteem (Mendelson, Mendelson, & White, 2001) Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
Secondary Change from Baseline in The Eating Attitudes Test (EAT-26) Eating Attitudes Test- 26 items The Eating Attitudes validated scale for children and adolescents (Maloney, McGuire, & Daniels, 1988) Measured three times over six months: at baseline, after the course ends, and three months after the completion of the course, measuring a change in scores
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