Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03849924 |
| Other study ID # |
NHS001384 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2018 |
| Est. completion date |
September 28, 2018 |
Study information
| Verified date |
February 2019 |
| Source |
University of Manchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study evaluates whether a brief psychological intervention, known as a self-affirmation
intervention which works by allowing one to recognise their own value, can improve
well-being. This study also evaluates whether more of these interventions will lead to
greater increases in well-being, and also measures self-esteem and anxiety to examine their
potential involvement in the self-affirmation process. Participants are randomly assigned to
either a self-affirmation intervention group, a 'booster' self-affirmation group whereby they
receive the intervention twice, or a control group (no intervention). Participant's
well-being, self-esteem and anxiety are assessed at baseline (before the intervention), 1
week, and 2 weeks after the intervention. It is hypothesised that those who undergo
self-affirmation will have more improved levels of well-being than those who do not; those
who undergo the self-affirmation twice will have the most improved levels of well-being. It
is also hypothesised that self-esteem and state anxiety will be involved in the
self-affirmation process and potentially mediate the effects of self-affirmation on
well-being.
Description:
Subjective well-being, refers to an appraisal of one's own life as a whole. Subjective
well-being is regularly being used by governments as a measure of observing social progress,
informing new policy and promoting behaviour change, in comparison to more objective measures
of social progress such as gross domestic product. A key aim of government policies is
therefore to find the most efficient, cost-effective ways to improve people's subjective
well-being, to determine the most efficient ways of improving quality of life. There are
currently a number of ways in which the government is attempting to address this, with
programs in place that are designed to improve people's well-being, such as Altogether Better
(Yorkshire and Humber Strategic Health Authority) and Target Well-being (Federation of
Groundwork Trust), as well as NHS programmes and free well-being courses. However, these
programmes were not always found to be effective in improving people's well-being,
particularly when the programmes involved health awareness activities. This limited
effectiveness of programmes involving health awareness activities makes them unlikely to be
cost-effective as a well-being intervention. This suggests the importance of developing an
effective intervention to improve people's well-being, that could also be used within
government/NHS well-being programs, to enhance the effectiveness of said programs in
improving well-being to make them more cost-effective, particularly in those promoting health
awareness.
Self-affirmation theory provides an approach to improve subjective well-being by overcoming
feelings of threat to the self. A threat to one's sense of self could undermine one's
subjective well-being. Self-affirmation theory states that people strive to maintain a
positive, moral and adaptive self-image, and that threats to the self (e.g., a smoker being
told that smoking is bad for them), motivates them to defend their global sense of self
(e.g., by convincing themselves that the information is flawed). According to
self-affirmation theory, people's sense of self can also be protected by bolstering
self-image in a domain that is not under direct threat. For example, if one feels that their
sense of self is threatened in a certain domain (e.g., by anti-smoking messages), then one
can bolster self-image by compensating in another domain (e.g., by doing charity work). There
is a large amount of evidence to support this theory, mostly from studies in which
self-affirmation manipulations (i.e. by reminding people of their 'core values') have been
found to be effective in overcoming threats to the self and promoting receptiveness to
health-risk communications.
The effectiveness of self-affirmation in overcoming threats to the self is not specific to
health-risk communications as research has found self-affirmation also to be effective in
overcoming threats to the self that occur within other domains, such as self-esteem, anxiety
and well-being, suggesting that they could be employed to protect subjective well-being
across populations at a low cost. There are limitations associated with research in this area
however, as there have only been very few studies that have looked at the effects of
self-affirmation on well-being and their samples are often limited and lack generalisability.
Also, no research to date has measured whether more self-affirmation interventions would
produce greater effects. This is of importance as research has regularly demonstrated
evidence of dose dependant relationships between a psychological intervention and its
subsequent effects, with a greater number of psychological interventions being associated
with greater effects. It would also be beneficial if research were to be conducted to
determine the effects of self-affirmation in a sample of people who are already undergoing a
well-being intervention (e.g., a government programme or NHS course), to see whether
self-affirmation can enhance the effectiveness of the intervention in improving well-being,
as this has not yet been explored and could help to make the intervention more
cost-effective. Therefore, the present study aims to confirm this positive effect of
self-affirmation on subjective well-being in a sample that consists of a wider range of
backgrounds and demographics that are already undergoing a well-being intervention.
In addition to this, there has been research that has looked at examining mediators of the
self-affirmation process, however the mechanisms for explaining the effects of
self-affirmation are not yet clearly understood. Some research has found evidence of
self-esteem acting as a mediator in the self-affirmation process. However, more research
needs to be conducted to confirm these findings as they have been inconsistent, with some
research showing no evidence of self-esteem acting as a mediator. Furthermore, other research
has found that self-affirmation led to reductions in state anxiety. This suggests state
anxiety may be acting as a mediator in the self-affirmation process, as undergoing
self-affirmation resulted in changes in state anxiety, with the self-affirming effects
possibly being occurring due to reductions in state anxiety. As there has been no research
that has addressed this possibility of state anxiety acting as a mediator in the
self-affirmation process, research should be conducted on this as this as this would allow
greater understanding of the mechanisms involved.
Accordingly, the present study will test the ability of self-affirmation to promote and/or
protect subjective well-being by comparing differences in subjective well-being in those that
undergo self-affirmation interventions with those that do not. The study will also compare
the difference between the effects of one self-affirmation intervention with that of two
self-affirmation interventions (i.e. the 'booster' condition), to determine whether there is
a dose-dependent relationship of the effects of self-affirmation. The present study will also
measure the effects of self-affirmation on self-esteem and state anxiety to test the
possibility of mediators of the self-affirmation process. Participants will be recruited from
an NHS college which runs free courses that are designed to help people improve their health
and/or well-being. It is likely that those who attend this college may feel threatened by the
courses, such as feeling threatened by opening-up and talking through issues during the
courses, which would lead to defensive processing and undermine the effectiveness of the
courses in their aim of improving people's well-being. Self-affirmation could help to
overcome these feelings of threat by reducing defensive processing, which could then enhance
the effectiveness of the courses in helping people improve their well-being. This is a
particularly important population to recruit from as the courses ran by the college often
promote health awareness, which research has identified as being less effective in improving
well-being. Self-affirmation interventions could therefore help to improve the
cost-effectiveness of the courses.
The present study has three aims; the first aim is to confirm previous findings that brief
self-affirmation interventions can enhance and protect subjective well-being, in a sample of
people already undergoing a well-being intervention, to see whether self-affirmation can
enhance the effectiveness of the intervention. The second aim is to examine the possibility
of mediators involved in producing the effects of self-affirmation, namely state anxiety,
self-esteem and self-esteem domains, to increase understanding of the mechanisms involved in
the self-affirmation process. State anxiety and self-esteem have been decided upon due to the
inconsistent findings surrounding self-esteem acting as a mediator of self-affirmation and
the lack of research on state anxiety acting as a mediator of self-affirmation. The third aim
is to measure whether this effect of self-affirmation on subjective well-being is greater in
those that undergo a greater number of self-affirmation interventions, as to whether or not
there is a dose-dependent relationship between self-affirmation and its' effect on subjective
well-being. This could then be used in practice to further enhance the positive effects of
self-affirmation, by providing more self-affirming interventions for example. It is
hypothesised that there will be higher levels of subjective well-being, after controlling for
baseline scores, in those that receive a self-affirmation intervention compared to those that
do not. Also, this effect will be greater, with more improved levels of subjective
well-being, in those that receive the self-affirmation intervention twice compared to those
that only receive it once. This is hypothesised due to findings from research in other
domains of more psychological interventions producing greater effects; known as a
dose-dependent relationship. It is also hypothesised self-esteem and state anxiety will act
as mediators in the self-affirmation process, based on previous findings of relationships
between them and self-affirmation.
Participants- Based on the medium effect size of f = 0.25 for a within/between-participants
MANOVA of three levels and three dependent variables, G-power software was used to conduct a
power analysis to calculate the required sample size. A medium effect size was used for this
analysis as there has been little previous research on self-affirmation in which there were
three levels of the between participants factor and three dependant variables. As the
analysis required an F-test with a between-factors MANOVA with three levels, also assuming an
error probability of 0.05 and a statistical power of 0.80, it presented a required sample
size estimated to be N = 81.
Accordingly, this study aimed to recruit a total of 100 participants to allow for attrition.
This was calculated based on findings of a median retention rate (participants that had
completed baseline and follow-up) of 89% from 151 longitudinal randomised control trials
(RCT). However, these RCT's were clinical trials in which participants were often offered
incentives for participating, with follow-up regularly being retrieved from medical files, as
84% of all trials were conducted in a hospital or general practice (GP) setting. Therefore,
as the participants in the present study were not offered any incentives for participation
and the study is not being carried out in a hospital setting, there are likely to be higher
attrition rates when compared to those calculated based on previous RCT's. To account for
this likelihood of higher attrition rates, the initial participant recruitment aim of 90
participants was rounded up to 100 participants.
Participants are to be recruited via opportunity sampling from an NHS college, in the
North-West area of England, which runs a variety of free courses lasting from 2-8 weeks.
These courses aim to enhance people's health and well-being. Examples of the courses run by
the college include courses on improving sense of control, recovery from depression and anger
management. Participants will be recruited from this college as it is likely that those who
attend these college courses may feel threatened by the nature of the courses, by having to
talk through personal issues during the courses for example, which may then inhibit the
effectiveness of the courses in improving well-being. The present study therefore recruited
people from this college in order to see whether self-affirmation could help people to
overcome feelings of threat generated by the courses, and so enhance the effectiveness of the
courses in improving well-being; increasing the cost-effectiveness of the courses.
Participants will not be offered any incentives for participating in the study.
Proposed Analysis- To measure the effectiveness of the randomisation procedure a MANOVA,
using SPSS, will be conducted. The independent variable will be condition with 3 levels:
'standard' self-affirmation, 'booster' self-affirmation and a control. The dependant
variables will be age, gender and baseline measures of subjective well-being, self-esteem and
state anxiety. If the multivariate and univariate tests are non-significant then this will
demonstrate that the participants were successfully randomised to the conditions.
To measure the effects of self-affirmation on subjective well-being a mixed 3 x 3 ANOVA,
using SPSS, will be conducted. The between-participants factor will be condition with 3
levels ('standard' self-affirmation vs 'booster' self-affirmation vs control), and the within
participants factor will be time with 3 levels (baseline assessment vs 'booster' assessment
vs follow-up assessment). The dependent variable will be subjective well-being. An ANCOVA
will be conducted to explore any significant interactions. For the ANCOVA, the
between-participants factor will be condition, the dependent variable will be follow-up
scores and the covariate will be baseline scores. Mediator analysis will also be conducted to
examine whether self-esteem and state anxiety act as mediators in the self-affirmation
process. This will be done using R software via the 'mediation' package.
Ethical Considerations- Ethical approval has been granted via HRA and REC ethics.
Participants will be informed that by completing and handing in the questionnaire they are
consenting to participate in the study. Participants will be informed that they do not have
to participate in the study if they do not want to and they can choose to withdraw from the
study, and withdraw their data, at any time. Participants will also be informed that their
data will remain anonymous and confidential as participants' names, and any other
identifiable information, will not be required.
Due to the follow-up nature of the study, the participants' baseline and follow-up
questionnaires will need to be matched. In order to match the participants' two
questionnaires, whilst keeping their data anonymous and confidential, they will be asked to
create an identifiable code and state this on both questionnaires. Data storage will comply
with the requirements of the Data Collection Act 1998. All manual data (i.e. participant
questionnaires) will be immediately transferred onto a protected university computer, by
copying the data onto an Excel spreadsheet once the data has been collected. The manual data
will be shredded immediately after it has been transferred onto the protected university
computer. All data will be stored on the protected university computer under password
protected folders and removed once the 5-year data storage period ends, via deleting the
files and removing them from the recycling bin, only the chief and principal investigators
will have access to the protected university computer. Study data and material may be looked
at by individuals from the University of Manchester, from regulatory authorities or from the
NHS Trust, for monitoring and auditing purposes.
Although participants will originally be informed that the questionnaires are assessing
personal and social beliefs, participants will be verbally debriefed on the true nature of
the study by the principal investigator, after the follow-up questionnaires have been
completed. Not informing participants of the true nature of the study, that it will involve
using self-affirmation, is necessary as research has found that awareness of the
self-affirmation process may diminish its impact. Participants' demographic variables will
also be assessed (e.g., age, gender, income), which some may find intrusive. However,
participants will be advised that they do not have to provide this information if they do not
wish to and instead they can leave this blank. Appropriate contact details from the
University of Manchester will be provided to participants to allow them to contact someone if
they have any issues surrounding the research, during or after the study.
