Preventive TherapyNCT04129892
In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students.
A study testing "In Favor of My Resilient Self" Academic course in people with Preventive Therapy, run by Tel Hai College at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preventive Therapy
- What is being tested?
- "In Favor of My Resilient Self" Academic course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Aug 2019to 1 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students at Tel Hai College that are interested in participating in the study, and provided informed consent.
Who cannot join
- Students that did not provide informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Hai Academic College
Kiryat Shmona, North of Israel, 1220800
Maya Mouallem, B.Sc
About this study
Official title: In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students, While Comparing Sciences and Social Studies Faculties.
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:
- Measure the effects on the emotional resilience and confidence of participants.
- Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
- 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.
Read the detailed 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:
- Measure the effects on the emotional resilience and confidence of participants.
- Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
- 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.
- Conditions
- Preventive Therapy
- Being tested
- "In Favor of My Resilient Self" Academic course
- Keywords
- Resilience, Academic course, College students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"In Favor of My Resilient Self" Academic courseBehavioural
Assessing the effect of an academic course on student's emotional resilience.
| Study group | Role | What they receive |
|---|---|---|
| Course participants | Experimental | Students that enroll in the Resilience-based course during their Bachelor of science or Bachelor of social studies. Receives: Behavioral: "In Favor of My Resilient Self" Academic course |
| Control group- no intervention | No intervention | Students in their Bachelor of science or Bachelor of social studies that did not attend the course, but agreed to fill out the study questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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 outcomes (5)
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: 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
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: 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
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: 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
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: 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
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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start3 Aug 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moria Golan, Prof., Principal investigator, Tel Hai College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129892
- Sponsor's protocol ID
- Tel Hai
- Status last verified
- Jun 2021
- First submitted
- 15 Oct 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students, While Comparing Sciences and Social Studies Faculties.
- ClinicalTrials.gov ID
- NCT04129892
- Acronym / sponsor ID
- Tel Hai
- Conditions
- Preventive Therapy
- Keywords
- Resilience, Academic course, College students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Measure the effects on the emotional resilience and confidence of participants.
- Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
- 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.
Detailed 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:
- Measure the effects on the emotional resilience and confidence of participants.
- Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Course participants | Experimental | Behavioral: "In Favor of My Resilient Self" Academic courseStudents that enroll in the Resilience-based course during their Bachelor of science or Bachelor of social studies. |
| Control group- no intervention | No intervention | –Students in their Bachelor of science or Bachelor of social studies that did not attend the course, but agreed to fill out the study questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students at Tel Hai College that are interested in participating in the study, and provided informed consent.
Key exclusion criteria (1 listed)
- Students that did not provide informed consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "In Favor of My Resilient Self" Academic courseAssessing the effect of an academic course on student's emotional resilience. | Behavioural | Course participants |
Primary outcome
Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 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
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: 1. Personal competence, high standards, and tenacity 2. Trust in one's instincts, tolerance of negative affect, and strengthening effects of stress 3. Positive acceptance of change and secure relationships 4. Control 5. 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).
5 secondary outcomes
Change from Baseline in Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4R)
Time frame: 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
Change from Baseline in Rosenberg Self-Esteem Scale (RSE)
Time frame: 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
Change from Baseline in Depression, Anxiety and Stress Scale (DASS-21)
Time frame: 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
Change from Baseline in Body Esteem Scale (BES)
Time frame: 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
Change from Baseline in The Eating Attitudes Test (EAT-26)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moria Golan, Prof. principal investigator
Tel Hai College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "In Favor of My Resilient Self" Academic course in people with Preventive Therapy, run by Tel Hai College at 1 site in Israel.
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 1 inclusion and 1 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Contact Maya Mouallem, M.Sc (+972524285382, smayal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2021.