- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121116
Effects of Mindfulness Training on Memories of Personal Past Events
Effects of Mindfulness Training on Autobiographical Memory
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ingen Region
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St Andrews, Ingen Region, United Kingdom
- University of St Andrews
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native or fluent English speaker
- Being 18-65 years old
- At least one past major depressive episode
Exclusion Criteria:
- Current depressive episode
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Active intervention condition
Participation in an 8-week, online, self-directed MBSR program.
|
Participation in an 8-week MBSR program consisting of pre-recorded mindfulness practices, including 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 practices last approximately 30 minutes and participants were 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.
Participants had immediate access to all practices but were asked to complete them sequentially and in the order described above over a period of eight weeks.
The MBSR program also encourages participants to employ mindfulness in their daily lives, and gives access to educative readings and videos related to the weekly mindfulness practices.
|
NO_INTERVENTION: Waitlist control condition
Participants in the waitlist control condition received no active intervention during the trial period but received a link to the MBSR program after completing the post-intervention assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the employment of emotion regulation strategies in response to everyday involuntary and voluntary autobiographical memories from baseline to post-intervention
Time Frame: Baseline to post-intervention, an average of 11 weeks
|
Self-rated (1 = Not at all, to 5 = A great deal) memory suppression ("I tried not to keep thinking about it"), expressive suppression ("I controlled my emotion by not expressing it"), reflection ("I analyzed the event to try to understand my feelings"), brooding ("I thought: Why do I always react this way?", cognitive reappraisal ("I changed the way I was thinking about the situation"), and non-reactivity ("I noticed the memory and feelings without having to react to them") in response to autobiographical memories was measured with a naturalistic memory diary method.
Participants were asked to record and rate involuntary autobiographical memories in the memory diary immediately upon retrieval, over a period of up to five days or until they had recorded seven memories.
For each involuntary memory recorded in the memory diary, participants were instructed to record and rate a word-cued (voluntary) memory when they had time later that day.
|
Baseline to post-intervention, an average of 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depression symptoms from baseline to post-intervention
Time Frame: Baseline through study completion, an average of 11 weeks
|
Self-report measure: Depression, Anxiety, Stress Scales (DASS)
|
Baseline through study completion, an average of 11 weeks
|
Change in trait mindfulness from baseline to post-intervention
Time Frame: Baseline to post-intervention, an average of 11 weeks
|
Self-report measure: Five Facet Mindfulness Questionnaire (FFMQ)
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Baseline to post-intervention, an average of 11 weeks
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Change in thought suppression from baseline to post-intervention
Time Frame: Baseline to post-intervention, an average of 11 weeks
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Self-report measure: White Bear Suppression Inventory (WBSI)
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Baseline to post-intervention, an average of 11 weeks
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Change in expressive suppression and cognitive reappraisal from baseline to post-intervention
Time Frame: Baseline to post-intervention, an average of 11 weeks
|
Self-report measure: Emotion Regulation Questionnaire (ERQ)
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Baseline to post-intervention, an average of 11 weeks
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Change in rumination (brooding, reflection, overall) from baseline to post-intervention
Time Frame: Baseline to post-intervention, an average of 11 weeks
|
Self-report measure: Ruminative Response Scale (RRS)
|
Baseline to post-intervention, an average of 11 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Dritschel, University of St Andrews
Publications and helpful links
General Publications
- Isham AE, del Palacio-Gonzalez A, Dritschel B. Trait Mindfulness and Emotion Regulation upon Autobiographical Memory Retrieval during Depression Remission. Mindfulness. 2020;11(12):2828-40.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StAMBSR1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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