NCT05121116

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable depression

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

Study Start

First participant enrolled

January 22, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

October 21, 2021

Last Update Submit

November 3, 2021

Conditions

Keywords

Depression vulnerabilityMindfulness-Based Stress ReductionRandomised controlled trialWaitlist control

Outcome Measures

Primary Outcomes (1)

  • Change in the employment of emotion regulation strategies in response to everyday involuntary and voluntary autobiographical memories from baseline to post-intervention

    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 Outcomes (5)

  • Change in depression symptoms from baseline to post-intervention

    Baseline through study completion, an average of 11 weeks

  • Change in trait mindfulness from baseline to post-intervention

    Baseline to post-intervention, an average of 11 weeks

  • Change in thought suppression from baseline to post-intervention

    Baseline to post-intervention, an average of 11 weeks

  • Change in expressive suppression and cognitive reappraisal from baseline to post-intervention

    Baseline to post-intervention, an average of 11 weeks

  • Change in rumination (brooding, reflection, overall) from baseline to post-intervention

    Baseline to post-intervention, an average of 11 weeks

Study Arms (2)

Active intervention condition

EXPERIMENTAL

Participation in an 8-week, online, self-directed MBSR program.

Behavioral: Online Mindfulness-Based Stress Reduction (MBSR)

Waitlist control condition

NO INTERVENTION

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.

Interventions

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.

Active intervention condition

Eligibility Criteria

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

You may qualify if:

  • Native or fluent English speaker
  • Being 18-65 years old
  • At least one past major depressive episode

You may not qualify if:

  • Current depressive episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of St Andrews

St Andrews, Ingen Region, United Kingdom

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Barbara Dritschel

    University of St Andrews

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized waitlist-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 16, 2021

Study Start

January 22, 2018

Primary Completion

June 14, 2020

Study Completion

June 14, 2020

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

The raw data underpinning this study cannot be made available to other researchers due to ethical concerns since there is not agreement from the participants to share their data.

Locations