NCT04013451

Brief Summary

The objective of this study is to assess the impact of engaging in deliberate acts of kindness on resilience (primary outcome); social interaction anxiety and affect (secondary outcomes); and mood (exploratory outcome) of undergraduate and graduate students at Western University (UWO). Recruitment of 200 participants consisting of 150 full-time undergraduate and 50 graduate students, randomized to either the intervention (n=100) or control group (n=100) will be achieved via a mass email to all full-time students at UWO. Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from UWO's Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness. Individuals in the intervention group will also receive a list of deliberate acts of kindness ideas, for reference. Baseline, immediate post intervention, and three-months post intervention data will be collected using previously validated questionnaires associated with each outcome of interest, and posted to Qualtrics, an online survey tool. Additionally, immediately following the intervention and 3 months post intervention all participants will complete an open-ended question asking them to describe their overall experience being involved in the study. Quantitative and qualitative data analysis will occur upon the completion of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

June 28, 2019

Last Update Submit

April 28, 2020

Conditions

Keywords

kindnesssocial interaction anxietymoodaffectresilienceundergraduate studentsgraduate students

Outcome Measures

Primary Outcomes (1)

  • Resilience (Brief Resilience Scale)

    The Brief Resilience Scale (BRS) includes 6-items; items 1, 3, and 5 are positively worded and items 2, 4, and 6 are negatively worded. Participants will be asked the extent to which they agree or disagree with the statements using a 5-point scale; 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The BRS is scored by reverse coding items 2, 4, and 6, such that 5 = strongly disagree, 4 = disagree, 3 = neutral, 2 = agree, and 1 = strongly agree. The mean of the six items is then determined to score the scale.

    Change from baseline resilience at immediate post-intervention and 3-month post-intervention

Secondary Outcomes (2)

  • Social interaction anxiety (Social Interaction Anxiety Scale-Straightforward)

    Change from baseline social interaction anxiety at immediate post-intervention and 3-month post-intervention

  • Affect (International Positive and Negative Affect Schedule-Short Form)

    Change from baseline affect at immediate post-intervention and 3-month post-intervention

Other Outcomes (1)

  • Mood (Brief Mood Introspection Scale)

    Change from baseline mood at immediate post-intervention and 3-month post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants allocated to the intervention group will participate in the intervention (acts of kindness).

Behavioral: Acts of kindness

Control Group

NO INTERVENTION

Participants allocated to the control group will not participate in the intervention and will act as the comparison condition.

Interventions

Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from Western University's (UWO) Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • full-time undergraduate or graduate students at Western University (UWO) and/or the affiliate schools (Kings, Brescia, Huron)
  • English-speaking

You may not qualify if:

  • non-English-speaking (i.e. unable to understand and complete surveys/questionnaires)
  • part-time students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

Related Publications (16)

  • Patel V, Flisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health challenge. Lancet. 2007 Apr 14;369(9569):1302-1313. doi: 10.1016/S0140-6736(07)60368-7.

    PMID: 17434406BACKGROUND
  • Dachew BA, Azale Bisetegn T, Berhe Gebremariam R. Prevalence of mental distress and associated factors among undergraduate students of University of Gondar, Northwest Ethiopia: a cross-sectional institutional based study. PLoS One. 2015 Mar 20;10(3):e0119464. doi: 10.1371/journal.pone.0119464. eCollection 2015.

    PMID: 25794278BACKGROUND
  • Adlaf EM, Gliksman L, Demers A, Newton-Taylor B. The prevalence of elevated psychological distress among Canadian undergraduates: findings from the 1998 Canadian Campus Survey. J Am Coll Health. 2001 Sep;50(2):67-72. doi: 10.1080/07448480109596009.

    PMID: 11590985BACKGROUND
  • Association, American College Health, E. (2016). ACHA - National College Health Assessment II: Ontario Canada Reference Group Executive Summary Spring 2016. American College Health Association, 1-18.

    BACKGROUND
  • Evans TM, Bira L, Gastelum JB, Weiss LT, Vanderford NL. Evidence for a mental health crisis in graduate education. Nat Biotechnol. 2018 Mar 6;36(3):282-284. doi: 10.1038/nbt.4089. No abstract available.

    PMID: 29509732BACKGROUND
  • Paviglianiti, N. C., & Irwin, J. D. (2017). Students ' Experiences of a Voluntary Random Acts of Kindness Health Promotion Project, 1(August), 1-23

    BACKGROUND
  • Lyubomirsky, S., & Della Porta, M. D. (2010). Boosting happiness, buttressing resilience. Handbook of adult resilience, 450-464.

    BACKGROUND
  • Rossouw, P. J., & Rossouw, J. G. (2016). The predictive 6-factor resilience scale: Neurobiological fundamentals and organizational application. International Journal of Neuropsychotherapy, 4(1), 31-45.

    BACKGROUND
  • Lyubomksky, S., Sheldon, K. M., & Schkade, D. (2005). Pursuing happiness: The architecture of sustainable change. Review of General Psychology, 9(2), 111-131. https://doi.org/10.1037/1089-2680.9.2.111

    BACKGROUND
  • Cutler J, Campbell-Meiklejohn D. A comparative fMRI meta-analysis of altruistic and strategic decisions to give. Neuroimage. 2019 Jan 1;184:227-241. doi: 10.1016/j.neuroimage.2018.09.009. Epub 2018 Sep 7.

    PMID: 30195947BACKGROUND
  • Thorne, S., Kirkham, S. R., & O'Flynn-Magee, K. (2004). The analytic challenge in interpretive description. International journal of qualitative methods, 3(1), 1-11.

    BACKGROUND
  • The Unviersity of Western Ontario (N.D.). Relaxation and Stress Management. http://studentexperience.uwo.ca/docs /RelaxationAndStress Management.pdf

    BACKGROUND
  • Trew, J. L., & Alden, L. E. (2015). Kindness reduces avoidance goals in socially anxious individuals. Motivation and emotion, 39(6), 892-907.

    BACKGROUND
  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PMID: 18696313BACKGROUND
  • Mayer JD, Gaschke YN. The experience and meta-experience of mood. J Pers Soc Psychol. 1988 Jul;55(1):102-11. doi: 10.1037//0022-3514.55.1.102.

    PMID: 3418484BACKGROUND
  • Patton, M. Q. (2002). Two decades of developments in qualitative inquiry: A personal, experiential perspective. Qualitative social work, 1(3), 261-283.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jennifer D Irwin, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full-time Professor, Faculty of Health Sciences

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 9, 2019

Study Start

September 27, 2019

Primary Completion

February 18, 2020

Study Completion

March 23, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) will be disseminated via publications and presentations.

Shared Documents
STUDY PROTOCOL
Time Frame
The intervention will take place during the month of November 2019 and the trial protocol will be submitted for publication; manuscript preparation will occur starting April 2020.

Locations