NCT04517006

Brief Summary

The COVID-19 pandemic and the accompanying lockdown measures have made mental health a pressing public health concern. Acts that focus on benefiting others-known as prosocial behaviors-offer one promising intervention that is both flexible and low cost. However, neither the range of emotional states prosocial acts impact nor the size of those effects is currently clear, both of which directly influence its attractiveness as a treatment option. Using a large online sample from Canada and the United States, the investigators will examine the effect of a three-week prosocial intervention on two indicators of emotional well-being (happiness and the belief that one's life is valuable) and mental health (anxiety and depression). Respondents will be randomly assigned to perform prosocial, self-focused, or neutral behaviors each week. Two weeks after the intervention, a final survey will assess whether the intervention has a lasting effect on mental health and emotional well-being. The results will illuminate whether prosocial interventions are a viable approach to addressing mental health needs during the current COVID-19 pandemic, as well for those who face emotional challenges during normal times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

August 14, 2020

Last Update Submit

May 25, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in happiness from baseline using the subjective happiness scale

    The Subjective Happiness Scale consists of four items: (1) "In general, I consider myself \_\_\_\_\_\_\_." Responses options run from 1 = "not a very happy person" to 7= "a very happy person." (2) "Compared to most of my peers, I consider myself \_\_\_\_\_\_\_\_" with response options from 1 = "less happy" to 7 = "more happy." (3) "Some people are generally very happy. They enjoy life regardless of what is going on, getting the most out of everything. To what extent does this characterization describe you?" (1 = "not at all" to 7 = "a great deal"). (4) "Some people are generally not very happy. Although they are not depressed, they never seem as happy as they might be. To what extent does this characterization describe you?" (1= "not at all" to 7= "a great deal"; reverse coded) These four items will be averaged into a scale ranging from 1-7, where higher scores indicate greater subjective happiness.

    baseline, end of weeks 1, 2, 3, and 5

  • Change in valued life assessment from baseline using 4-item scale

    Respondents' individual perceptions of whether their life has value will be measured using the valued life subscale developed by Morgan and Farsides. This measure will consist of the average of the following four items: (1) "My life is worthwhile," (2) "My life is significant," (3) I really value my life," and (4) I hold my own life in high regard." In each instance, response options will run from -3 = "strongly disagree" to 3 = "strongly agree".

    baseline, end of weeks 1, 2, 3, and 5

  • Change in depression from baseline using the CESD (8-item)

    Depression will be measured using the well-established 8-item short-form of the Centre for Epidemiological Studies-Depression Scale (CES-D). Respondents will report how often in the past week they (1) felt depressed, (2) felt that everything was an effort, (3) felt that sleep was restless, (4) felt happy (reverse coded), (5) enjoyed life (reverse coded), (6) felt lonely, (7) felt sad, and (8) could not get going. Responses will be scored where 0 = "rarely or none of the time," 1 = "some of the time," 2 = "a moderate amount of time," and 3 = "most or all of the time."

    baseline, end of weeks 1, 2, 3, and 5

  • Change in anxiety from baseline using the HADS-A

    Anxiety will be measured with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A), which is both commonly used and well-validated. This is a 7-item scales that asks respondents how often in the past week they: (1) felt tense or wound up, (2) got a frightened feeling as if something awful was about to happen, (3) had worrying thoughts go through their mind, (4) got a frightened feeling like butterflies in the stomach, (5) felt restless as if they had to be on the move, (6) had a sudden feeling of panic, and (7) could sit at ease and feel relaxed. To ensure consistency with our measure of depression, responses will be coded where 0 = "rarely or none of the time," 1 = "some of the time," 2 = "a moderate amount of time," and 3 = "most or all of the time."

    baseline, end of weeks 1, 2, 3, and 5

Study Arms (3)

Track activities

NO INTERVENTION

For three weeks research subjects will be keeping track of the things they do without altering their routine in any way.

Self-focused acts

EXPERIMENTAL

For three weeks research subjects will be "treating themselves" by doing things that they enjoy. These acts don't have to be large or costly, but they should be over and above what they typically do. They are asked to do one (or more) things they enjoy each day for the first three days of each week and report them.

Behavioral: Self-focused acts

Prosocial acts

EXPERIMENTAL

For three weeks research subjects are asked to perform acts of kindness, meaning behaviors that benefit someone else and are over and above what they typically do (i.e., they are not expected of them). These acts should also involve some sacrifice by them (e.g., in effort, energy, time, or money) and be completed for the first three days of each week.

Behavioral: Prosocial acts

Interventions

Completion of daily acts for personal enjoyment.

Self-focused acts
Prosocial actsBEHAVIORAL

Completion of daily acts for the benefit of others.

Prosocial acts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Canadian and American respondents from the Amazon Mechanical Turk

You may not qualify if:

  • Respondents will be excluded from the study if any of the following apply:
  • A respondent completes the baseline study unrealistically quickly. We measure response speed using the average number seconds spent on each survey item (seconds per item, or SPI). We judge a response to be unrealistically fast if its SPI value is less than 1. SPI calculations will exclude optional items.
  • A respondent does not complete at least half of the items in the baseline survey.
  • A respondent provides off-topic, non-sensical (e.g., random or gibberish words), or non-English responses to an open-ended question in the baseline survey. The open-ended question follows a dictator game (that is not part of the pre-registered portion of the study) and asks respondents what they hoped to accomplish by acting as they did during the dictator game. The specific nature of this question will make it straightforward to detect off-topic responses. A comment must be judged as off-topic, non-sensical, or non-English by two members of the research team to be excluded.
  • A respondent does not agree to continue with the study when asked if they wish to continue taking part in the study at the end of the baseline study, or in private correspondence with the researchers.
  • A respondent completes the baseline study using an IP address from outside Canada or the United States, or that appears to originate from a VPS or other suspicious source.
  • Technical difficulties prevent a respondent from completing the baseline study.
  • Because obtain sufficient power to detect effects is a central aim of this study, the investigators will replace respondents who are removed for reasons 1-5 in a rolling fashion. In the case of technical failure (#6), the first approach will be to resolve the issue and administer the baseline survey to the same participant. If this is not possible, a replacement will be recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online, Amazon's Mechanical Turk

Toronto, Ontario, M5S 2J4, Canada

Location

Related Publications (6)

  • Morgan J, Farsides T. Measuring Meaning in Life. J Happiness Stud. 2009;10: 197-214. doi:10.1007/s10902-007-9075-0

    BACKGROUND
  • Kohout FJ, Berkman LF, Evans DA, Cornoni-Huntley J. Two shorter forms of the CES-D (Center for Epidemiological Studies Depression) depression symptoms index. J Aging Health. 1993 May;5(2):179-93. doi: 10.1177/089826439300500202.

    PMID: 10125443BACKGROUND
  • Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

    PMID: 11832252BACKGROUND
  • Lyubomirsky S, Lepper HS. A Measure of Subjective Happiness: Preliminary Reliability and Construct Validation. Soc Indic Res. 1999;46: 137-155.

    BACKGROUND
  • Kennedy R, Clifford S, Burleigh T, Waggoner PD, Jewell R, Winter NJG. The shape of and solutions to the MTurk quality crisis. Polit Sci Res Methods. 2020; 1-16. doi:10.1017/psrm.2020.6

    BACKGROUND
  • Wood D, Harms PD, Lowman GH, DeSimone JA. Response Speed and Response Consistency as Mutually Validating Indicators of Data Quality in Online Samples. Soc Psychol Personal Sci. 2017;8: 454-464. doi:10.1177/1948550617703168

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Andrew Miles, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

January 31, 2021

Primary Completion

April 4, 2021

Study Completion

April 4, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Using an OSF repository, other researchers and readers of the published study will have access to the IPD.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After the publication of the paper and perpetually. The investigators plan to publish the study as a registered report, so study information will also be available as part of the report protocol.
More information

Available IPD Datasets

Individual Participant Data Set Access
Statistical Analysis Plan Access
Informed Consent Form Access
Analytic Code Access

Locations