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AnxietyNCT04013451

The Kiss of Kindness Study II

A study testing Acts of kindness in people with Anxiety and Stress, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Anxiety, Stress, Mood
What is being tested?
Acts of kindness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteCanada
Study dates
27 Sep 2019to 23 Mar 2020
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Western University

    London, Ontario, N6A 3K7

Other trials in Canada

About this study

Official title: Kindness as an Intervention for Student Social Interaction Anxiety, Resilience, Affect, and Mood

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.

Read the detailed description

Poor mental health is a significant public health concern that disproportionally affects university students, compared to their community counterparts, and stress is a main culprit. Although privileged in terms of attending higher education, the stress-related inequity experienced among university students stems from "academic load, constant pressure to succeed, competition with peers, financial burdens, and peer, teacher or parental pressure". These stressors can trigger or exacerbate anxiety levels, which are on the rise among students. The most recent National College Health Assessment Survey, which included Canadian postsecondary institutions, showed a marked increase in student anxiety between 2013 to 2016. Although less studied than undergraduates, graduate students' mental health also is worrisome with over 60% feeling exhausted, overwhelmed, hopeless, and/or depressed nearly all of the time. It is imperative that evidence-informed approaches to enhance resilience and reduce the negative mental health experiences of undergraduate and graduate students be implemented and evaluated. Although improving resilience and overall mental health is a growing focus across campuses, current programming is clearly unable to address the concern in its entirety, and additional interventions are required.

An emerging and promising approach to promoting positive mental health and resilience among secondary students is performing acts of kindness. Arguably, performing acts of kindness improves mental health through the strengthening of psychological resilience. Resilience, as an outcome, is predicated on six underlying dimensions: health, collaboration, purpose, composure, reasoning, and tenacity. In terms of health and collaboration, a small classroom-based kindness pilot entailing logging acts of kindness by undergraduate students at Western University (UWO), found improvements in individual levels of wellbeing (i.e. confidence and decreased stress), perceptions of positive classroom culture, and classroom cohesion. Performing acts of kindness is correlated with happiness which results in a positive sense of purpose, increased composure, and improved reasoning and resilience. Moreover, the physiological effects are well-known as functional magnetic resonance images (fMRIs) show activation in the reward centres of the brain when subjects are engaged in acts of kindness. Despite the strong theoretical foundation that links acts of kindness with resilience, this area of research has yet to be sufficiently explored. To that end, 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 UWO.

Methods

Study Design

A longitudinal repeated-measures, mixed methods randomized control trial grounded in an interpretive description paradigm will be used. Interpretive description is an inductive analysis approach that creates ways of understanding phenomena yielding application-based implications for practice. 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 once ethical approval is obtained and the trial is registered. This sample size was selected considering two criteria: 1) based on our previous work in the area the sample size is feasible; and 2) from a power analysis using resilience as the primary outcome, a sample of 100 per group is sufficient to detect significant differences between groups (p < 0.05). Participants will be eligible if they are: (a) full-time undergraduate or graduate students at UWO and/or the affiliate schools (Kings, Brescia, Huron) and (b) English-speaking. Both intervention and control group participants will receive an email with access to a relaxation and stress management booklet from UWO's Wellness Education Centre. 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. Deliberate acts of kindness will be defined for participants as purposeful acts benefitting others that the others would presumably like.

Data Collection/Metrics

Baseline, immediate post intervention, and three-months post intervention data will be collected using Qualtrics, an online survey tool. Baseline will consist of basic demographic information, and four previously validated scales: (1) Brief Resilience Scale (BRS); (2) Social Interaction Anxiety Scale-Straightforward (SIAS-S); (3) International Positive and Negative Affect Schedule-Short Form (I-PANAS-SF); and (4) Brief Mood Introspection Scale (BMIS). The assessments will take 15-minutes to complete. After the completion of the baseline assessment participants will be randomized using stratification by degree level (i.e., undergraduate or graduate). Immediately following the intervention and 3 months post intervention all participants will complete the same assessments administered at baseline (minus demographics) with the addition of an open-ended question asking participants to describe their overall experience being involved in the study.

Data analysis

Data analysis will occur upon the completion of the study and quantitative data analysis will initially involve computing measures of central tendency and dispersion as well as the computation of the validated scales. Next, general linear models will be used to examine both differences between groups and overtime. For the qualitative data, inductive content analysis using interpretive description will be conducted independently, and simultaneously by two researchers who will subsequently meet, upon the completion of analysis, to determine agreement in emerging findings. Statistical Package for Social Sciences (SPSS) will be used for quantitative analysis and QSR International NVivo software will be used to code and categorize qualitative data. Knowledge Translation will involve both traditional mechanisms (publications/conferences) and engagement with social media (infographics, youtube videos).

Conditions
Anxiety, Stress, Mood, Affect
Being tested
Acts of kindness
Keywords
kindness, social interaction anxiety, mood, affect, resilience, undergraduate students, graduate students
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acts of kindnessBehavioural

    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.

Study groups in NCT04013451
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants allocated to the intervention group will participate in the intervention (acts of kindness).
Receives: Behavioral: Acts of kindness
Control GroupNo interventionParticipants allocated to the control group will not participate in the intervention and will act as the comparison condition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Social interaction anxiety (Social Interaction Anxiety Scale-Straightforward)

    The Social Interaction Anxiety Scale-Straightforward (SIAS-S) includes 20 items assessing cognitive, affective and behavioural aspects of social interaction anxiety using a five-point scale; 0 = not at all, 1 = slightly, 2 = moderately, 3 = very and 4 = extremely. Participants will be asked to indicate the degree to which they feel the statement is characteristic or true to them. The SIAS-S uses reverse coding, such that items 5, 9 and 11 are reverse scored; however, they are not included in the total score. A total score of 28 or higher indicates probable social interaction anxiety.

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

  2. Affect (International Positive and Negative Affect Schedule-Short Form)

    The International Positive and Negative Affect Schedule-Short Form (I-PANAS-SF) includes 20 items from the Positive and Negative Affect Schedule (10 items = positive affect; 10 items = negative affect) using a five-point scale; 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. Participants will be asked to indicate the extent they have felt the adjective over the past week. The positive affect score is obtained by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19. The negative affect score is obtained by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start27 Sep 2019
  3. Primary completion18 Feb 2020
  4. Study completion23 Mar 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013451
Sponsor's protocol ID
114103
Status last verified
Apr 2020
First submitted
28 Jun 2019
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be disseminated via publications and presentations.

Publications

  • 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.

    PubMed 17434406
  • 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.

    PubMed 25794278
  • 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.

    PubMed 11590985
  • 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.

  • 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.

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

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

  • 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.

  • 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

  • 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.

    PubMed 30195947
  • 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.

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

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

  • 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.

    PubMed 18696313
  • 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.

    PubMed 3418484

Questions about this trial

What is this clinical trial studying?

A study testing Acts of kindness in people with Anxiety and Stress, run by Western University, Canada at 1 site in Canada.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Apr 2020. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resilience (Brief Resilience Scale) (time frame: Change from baseline resilience at immediate post-intervention and 3-month post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04013451, which also lists 16 linked publications.

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 29 Apr 2020.

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