NCT04129892

Brief 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. 1.Measure the effects on the emotional resilience and confidence of participants.
  2. 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. 3.Understand the mechanisms of the effects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

October 15, 2019

Last Update Submit

June 29, 2021

Conditions

Preventive Therapy

Keywords

ResilienceAcademic courseCollege students

Outcome Measures

Primary Outcomes (1)

  • 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: 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).

    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)

    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)

    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)

    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)

    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)

    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

Study Arms (2)

Course participants

EXPERIMENTAL

Students that enroll in the Resilience-based course during their Bachelor of science or Bachelor of social studies.

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.

Interventions

"In Favor of My Resilient Self" Academic courseBEHAVIORAL

Assessing the effect of an academic course on student's emotional resilience.

Course participants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students at Tel Hai College that are interested in participating in the study, and provided informed consent.

You may not qualify if:

  • Students that did not provide informed consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Hai Academic College

Kiryat Shmona, North of Israel, 1220800, Israel

RECRUITING

Study Officials

  • Moria Golan, Prof.

    Tel Hai College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Mouallem, M.Sc

CONTACT

+972524285382smayal@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

August 3, 2019

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)