DepressionNCT05121116
Effects of Mindfulness Training on Memories of Personal Past Events
A study testing Online Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Mindfulness-Based Stress Reduction, run by Aleksandra Eriksen Isham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Mindfulness-Based Stress Reduction
- What is being tested?
- Online Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2018to 14 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native or fluent English speaker
- Being 18-65 years old
- At least one past major depressive episode
Who cannot join
- Current depressive episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness Training on Autobiographical Memory
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Depression, Mindfulness-Based Stress Reduction
- Being tested
- Online Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Depression vulnerability, Mindfulness-Based Stress Reduction, Randomised controlled trial, Waitlist control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness-Based Stress Reduction (MBSR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention condition | Experimental | Participation in an 8-week, online, self-directed MBSR program. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-intervention, an average of 11 weeks
Secondary outcomes (5)
Change in depression symptoms from baseline to post-intervention
Self-report measure: Depression, Anxiety, Stress Scales (DASS)
Measured: Baseline through study completion, an average of 11 weeks
Change in trait mindfulness from baseline to post-intervention
Self-report measure: Five Facet Mindfulness Questionnaire (FFMQ)
Measured: Baseline to post-intervention, an average of 11 weeks
Change in thought suppression from baseline to post-intervention
Self-report measure: White Bear Suppression Inventory (WBSI)
Measured: Baseline to post-intervention, an average of 11 weeks
Change in expressive suppression and cognitive reappraisal from baseline to post-intervention
Self-report measure: Emotion Regulation Questionnaire (ERQ)
Measured: Baseline to post-intervention, an average of 11 weeks
Change in rumination (brooding, reflection, overall) from baseline to post-intervention
Self-report measure: Ruminative Response Scale (RRS)
Measured: Baseline to post-intervention, an average of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start22 Jan 2018
- Primary completion14 Jun 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized waitlist-controlled
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleksandra Eriksen Isham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Aleksandra Eriksen Isham, University of St Andrews
- Investigators
- Barbara Dritschel, Principal investigator, University of St Andrews
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121116
- Sponsor's protocol ID
- StAMBSR1
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Training on Autobiographical Memory
- ClinicalTrials.gov ID
- NCT05121116
- Acronym / sponsor ID
- StAMBSR1
- Conditions
- Depression, Mindfulness-Based Stress Reduction
- Keywords
- Depression vulnerability, Mindfulness-Based Stress Reduction, Randomised controlled trial, Waitlist control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Aleksandra Eriksen IshamUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist-controlled
| Arm | Type | Receives |
|---|---|---|
| Active intervention condition | Experimental | Behavioral: Online Mindfulness-Based Stress Reduction (MBSR)Participation in an 8-week, online, self-directed MBSR program. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Native or fluent English speaker
- Being 18-65 years old
- At least one past major depressive episode
Key exclusion criteria (1 listed)
- Current depressive episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mindfulness-Based Stress Reduction (MBSR)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. | Behavioural | Active intervention condition |
Primary outcome
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.
5 secondary outcomes
Change in depression symptoms from baseline to post-intervention
Time frame: 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
Change in thought suppression from baseline to post-intervention
Time frame: Baseline to post-intervention, an average of 11 weeks
Change in expressive suppression and cognitive reappraisal from baseline to post-intervention
Time frame: Baseline to post-intervention, an average of 11 weeks
Change in rumination (brooding, reflection, overall) from baseline to post-intervention
Time frame: Baseline to post-intervention, an average of 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- BackgroundIsham 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Dritschel principal investigator
University of St Andrews
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Mindfulness-Based Stress Reduction, run by Aleksandra Eriksen Isham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.