Events Control Clinical Trial
Official title:
Cultivating Gratitude: Does Manipulating Expectations Improve the Efficacy of a Gratitude Intervention?
| NCT number | NCT03784001 |
| Other study ID # | 1997 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 5, 2019 |
| Est. completion date | February 28, 2019 |
| Verified date | May 2020 |
| Source | University of California, Los Angeles |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Gratitude - an emotion felt when an individual receives something beneficial from other
people or entities - has been shown to positively affect well-being. Beginning in 2003,
"count your blessings" interventions - in which participants list items they are grateful
for, and gratitude letter writing interventions were designed to cultivate gratitude.
Gratitude interventions have many positive outcomes; they can increase well-being and life
satisfaction (Froh, Sefick, & Emmons, 2008) and increase self-esteem (Rash, Matsuba, &
Prkachin, 2011) to name a few.
Knowing the benefits of gratitude prior to an intervention could affect participant behavior
and health outcomes. Past studies have illustrated that sharing information about treatments
changes expectations and improves outcomes (Zion & Crum, 2018). For instance, overt medical
treatments are more effective than hidden ones (Colloca, Lopiano, Lanotte, & Benedetti,
2004).
The proposed study is designed to evaluate whether expectations about intervention efficacy
can enhance the benefits of a brief gratitude intervention. Specifically, the investigators
will test if providing information on the benefits of gratitude will enhance intervention
outcomes. This 3-armed randomized controlled trial will have the following conditions:
gratitude + expectation, gratitude, and events control. Participants will be undergraduate
college students and the online intervention will last two weeks.
Participants in the two gratitude conditions will login to an online form three times a week
for two weeks and make entries of up to five things they are grateful for. The form for
participants in the gratitude + expectation condition will also provide information about
benefits of gratitude. An everyday events control will be used to provide a neutral
comparison condition. This group will be instructed to type up to five things or events of
note from their day on their form.
Outcome measures will be collected via an online survey before and immediately after the
intervention. The primary outcome is well-being and the secondary outcomes are sleep quality
and quantity, state gratitude, positive affect, healthcare self-efficacy, stress, and
depressive symptoms. The investigators predict that participants in the gratitude +
expectation condition will have enhanced intervention outcomes compared to participants in
comparison conditions.
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | February 28, 2019 |
| Est. primary completion date | February 28, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Undergraduate Student - Proficient in English - 18 years of age or older - Has a valid email address - Access to the internet Exclusion Criteria: -No other exclusion criteria (aside from meeting the inclusion criteria above) |
| Country | Name | City | State |
|---|---|---|---|
| United States | UCLA | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Los Angeles |
United States,
Bartlett MY, DeSteno D. Gratitude and prosocial behavior: helping when it costs you. Psychol Sci. 2006 Apr;17(4):319-25. — View Citation
Colloca L, Lopiano L, Lanotte M, Benedetti F. Overt versus covert treatment for pain, anxiety, and Parkinson's disease. Lancet Neurol. 2004 Nov;3(11):679-84. Review. — View Citation
Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. — View Citation
Froh JJ, Sefick WJ, Emmons RA. Counting blessings in early adolescents: an experimental study of gratitude and subjective well-being. J Sch Psychol. 2008 Apr;46(2):213-33. doi: 10.1016/j.jsp.2007.03.005. Epub 2007 May 4. — View Citation
Jackowska M, Brown J, Ronaldson A, Steptoe A. The impact of a brief gratitude intervention on subjective well-being, biology and sleep. J Health Psychol. 2016 Oct;21(10):2207-17. doi: 10.1177/1359105315572455. Epub 2015 Mar 2. — View Citation
Kruse, E., Chancellor, J., Ruberton, P.M., & Lyubomirsky, S. (2014). An upward spiral between gratitude and humility. Social Psychological and Personality Science. 5(7), 805-814. doi: 10.1177/1948550614534700
Rash, J. A., Matsuba, M. K., & Prkachin, K. M. (2011). Gratitude and well-being: who benefits the most from a gratitude intervention? Applied Psychology: Health and Well-Being, 3(3), 350-369. doi: 10.1111/j.1758-0854.2011.01058.x
Sheldon, K.M. & Lyubomirsky, S. 2006. How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology. 1(2). 73-82. doi:10.1080/17439760500510676
Watkins, P., Woodward, K., Stone, T., & Kolts, R. (2003). Gratitude and happiness: Development of a measure of gratitude and relationships with subjective well-being. Social Behavior and Personality: An international journal, 31, 431-452. doi: 10.2224/sbp.2003.31.5.431
Zion SR, Crum AJ. Mindsets Matter: A New Framework for Harnessing the Placebo Effect in Modern Medicine. Int Rev Neurobiol. 2018;138:137-160. doi: 10.1016/bs.irn.2018.02.002. Epub 2018 Mar 20. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mental Health Continuum-Short Form (MHC-SF) | Hedonic well-being, eudaimonic well-being, and overall well-being were assessed at baseline and post-intervention. Well-being was measured with the Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009). Participants rated how often they felt 14 different emotions or statements, such as "happy" and "satisfied with life". Items are rated on a 6-point likert scale (0 = never, 5 = everyday). This measure assesses both hedonic and eudaimonic well-being. The MHC-SF is both reliable and valid for use with young adults (Robitschek & Keyes, 2009). Total scores are created by the sum of scores for all 14 items, with a range of 0-70. Higher scores indicate greater overall well-being. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Primary | Mental Health Continuum-Short Form (MHC-SF): Hedonic Well-Being SubScale | Well-being was measured with the Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009). Participants rated how often they felt 14 different emotions or statements, such as "happy" and "satisfied with life". Items are rated on a 6-point likert scale (0 = never, 5 = everyday), with higher numbers indicating greater well-being. This measure assesses both hedonic and eudaimonic well-being. The MHC-SF is both reliable and valid for use with young adults (Robitschek & Keyes, 2009). The Hedonic Well-Being Subscale is the sum of items 1-3 on the Mental Health Continuum Short-Form. Total scores range from 0-15, with higher scores indicating greater hedonic well-being. Scoring a 4 or 5 on at least one of the 3 items on the Hedonic Well-Being Subscale indicates a diagnosis of flourishing mental health. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Primary | Mental Health Continuum-Short Form (MHC-SF): Eudaimonic Well-Being SubScale | Well-being was measured with the Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009). Participants rated how often they felt 14 different emotions or statements, such as "happy" and "satisfied with life". Items are rated on a 6-point likert scale (0 = never, 5 = everyday), with higher numbers indicating greater well-being. This measure assesses both hedonic and eudaimonic well-being. The MHC-SF is both reliable and valid for use with young adults (Robitschek & Keyes, 2009). The score of the Eudaimonic Subscale is the sum of items 4-14 on the MHC-SF. Scores range from 0-55. Higher scores indicate greater eudaimonic well-being (i.e., greater social and psychological well-being). | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale | Sleep quality was measured with the 8-item PROMIS sleep disturbance short form (Yu et al., 2012). Participants rated their level of agreement with eight different statements about their sleep in the past seven days such as "My sleep was restless" and "I had difficulty falling asleep". Participants rated each item on a 5 point scale (1 = not at all, 5 = very much). Items 2, 3, 7, and 8 were reverse scored. The total score of the PROMIS Sleep Disturbance Scale is the sum of the scores for all 8 items. Total scores range from 8-40, with higher scores indicating more severe sleep disturbance. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Pittsburg Sleep Quality Index (PSQI) Duration Items | Sleep quantity was measured with the Pittsburgh Sleep Quality Index Duration Items (PSQI-4), which asks participants questions such as when they went to bed and when they woke up in the morning (Buysse et al., 1989). PSQI duration items are questions 1-4 on the PSQI, which measure how much sleep respondents have been getting. Higher hours of sleep is a better outcome. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Modified Differential Emotions Scale (MDES): Positive Emotions Subscale | Positive affect was measured with the ten-item Positive Emotions (PE) subscale of the Modified Differential Emotions Scale (mDES) (Fredrickson, Tugade, Waugh, and Larkin, 2003). Participants rated how often they felt ten different groups of positive emotions such as "amused, fun-loving, silly" on a 5-point scale (0 = not at all, 4 = most of the time). The average of the items was calculated to measure positive affect, with higher numbers indicating greater positive affect. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Perceived Stress Scale - 4 (PSS-4) | Stress was measured with the 4-item Perceived Stress Scale (PSS-4; Cohen, Kamarack, and Mermelstein, 1983). Participants rated how often they felt a certain way in the last week on four different items such as "How often have you felt confident about your ability to handle your personal problems?" and "How often have you felt that things were going your way?" on a 5- point scale (0 = never, 4 = very often). The total score of the PSS-4 is the sum of all 4 items. Total scores range from 0-16, and higher scores indicate greater perceived stress. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | Depressive symptoms were measured by the Center for Epidemiological Studies - Depression Scale (CES-D, Radloff, 1977). Participants rated how often they experienced 20 different statements such as "I was bothered by things that usually don't bother me" and "I felt like everything I did was an effort" in the past week. Participants scored each item on a 4-point scale (0 = rarely or none of the time 3 = all of the time). The total score for the CES-D is the sum of all 20 items, with a range of 0-60, with higher scores indicating greater depressive symptoms. | Assessed at Pre- and Post- Intervention (2 weeks apart) | |
| Secondary | Modified Differential Emotions Scale (MDES): State Gratitude | State gratitude was measured with item one of the mDES (Fredrickson, Tugade, Waugh, and Larkin, 2003), which asks participants how often they felt "grateful, appreciative, or thankful" in the past two weeks. Participants rated this item on a 5-point scale (0 = not at all, 4 = most of the time), with a higher number indicating higher feelings of gratitude. | Assessed at Pre- and Post- Intervention (2 weeks apart) |