Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05121116 |
Other study ID # |
StAMBSR1 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 22, 2018 |
Est. completion date |
June 14, 2020 |
Study information
Verified date |
November 2021 |
Source |
University of St Andrews |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study was to assess the effects of participation in an online
Mindfulness-Based Stress Reduction (MBSR) program on everyday memories of personal past
events in individuals with depression vulnerability. Previous research has demonstrated that
individuals with depression experience various difficulties when thinking about personal past
events, such as more intense negative emotions, difficulties in regulating their emotions,
and difficulties in recalling highly contextualized and detailed events. Some of these
difficulties may continue following recovery from depression and as such may constitute a
vulnerability for recurring depression. Other studies have found that mindfulness-based
interventions (MBIs) may influence how people experience and regulate their emotions, and
certain aspects of how people remember personal past events. Therefore, it is possible that
MBIs may also influence how individuals with depression vulnerability emotionally process
memories of personal past events. In the present study participants with a history of
depression were allocated to either an 8-week online MBSR condition where participants were
introduced to and engaged in different mindfulness practices, or a waitlist-control
condition, where participants did not receive any active training or treatment. In order to
assess the effects of the MBSR program on everyday memories of personal past events
participants were asked to complete a memory diary in which participants recorded both
spontaneously arising and word-cued memories of personal past events in everyday life, before
and after participating in the MBSR program or the waitlist-control condition. The
investigators hypothesized that participants in the MBSR condition would report reduced
difficulties related to memories of personal past events compared to the waitlist-control
group, including how participants emotionally process these memories. The investigators
predicted that these effects would be greater for spontaneously occurring memories than for
voluntary memories, since previous research comparing individuals with different levels of
mindfulness skills suggests that mindfulness may be especially beneficial for influencing
emotion regulation in response to memories that come to mind spontaneously.
Description:
PRIMARY OBJECTIVE:
I. Determine the effects of an online, self-directed Mindfulness-Based Stress Reduction
(MBSR) program on emotion regulation in response to everyday involuntary and voluntary
(word-cued) autobiographical memories in individuals with a history of depression
SECONDARY AND EXPLORATORY OBJECTIVES:
I. Determine whether an online, self-directed MBSR program performs similar to MBIs in
previous studies in terms of effects on depression symptoms, trait mindfulness, and trait
emotion regulation; and whether the effects of this program are similar for trait and state
measures of emotion regulation.
II. Determine the effects of an online, self-directed MBSR program on additional aspects of
involuntary and voluntary autobiographical memories in individuals with a history of
depression, including memory specificity, centrality, and emotional experience in response to
the memories.
PARTICIPANT RECRUITMENT:
Participant recruitment was done as part of a larger research project on mindfulness and
autobiographical memory in depression vulnerability, which recruited both individuals with
and without a depression history. The outlined study uses data from a sample of remitted
depressed participants.
STUDY OUTLINE:
Participants were randomly allocated to either an 8-week active MBSR condition, or a
waitlist-control condition. Participants in both conditions received information about mental
health support organizations and student support options on campus following enrollment in
the study.
Participants assigned to the active MBSR intervention participated in an 8-week,
self-directed MBSR program which is freely available online (www.palousemindfulness.com).
This MBSR program consists of a guided body scan in week 1, guided sitting meditation in week
2, mindful yoga practices in week 3 and 4, meditation on difficult emotions in week 5,
visualization meditation in week 6, lovingkindness meditation in week 7, and a silent
meditation in week 8. Most mindfulness practices are planned to last approximately 30 minutes
and participants are encouraged to engage in a mindfulness practice daily or as often as
possible. In weeks 2 - 8 participants could choose to alternate the practice introduced each
week with practices from previous weeks. In addition to the formal mindfulness practices
described above, the MBSR program encourages participants to employ mindfulness in their
daily lives and gives access to educative readings and videos related to the weekly
mindfulness practices. Participants in the active intervention had immediate access to all
MBSR practices on the website but were asked to complete the practices sequentially and in
the order described above over a period of eight weeks.
Participants in the waitlist-control condition did not receive any intervention during the
trial, but were given a link to the MBSR program after completing the study.
In order to determine the effects of the MBSR program on everyday autobiographical memories,
all participants recorded everyday involuntary and voluntary (word-cued) autobiographical
memories in a naturalistic memory diary, and rated the memories along several dimensions,
including emotion regulation, emotional experience, memory specificity, and centrality.
Participants also completed self-report measures of depression symptoms, trait mindfulness,
trait emotion regulation, personal past events, and intervention adherence.
HYPOTHESES PRIMARY OBJECTIVE:
I. The investigators hypothesized that participants in the MBSR condition would show
decreased memory suppression, expressive suppression, brooding, and reflection, and increased
cognitive reappraisal and non-reactivity in response to autobiographical memories compared to
the waitlist-control group. The investigators predicted that these effects would be greater
for involuntary than for voluntary memories, since previous research on trait mindfulness and
emotion regulation in response to autobiographical memories suggests that mindfulness skills
may be especially beneficial for influencing emotion regulation in response to memories that
come to mind involuntarily.