NCT04749264

Brief Summary

Although attention is thought to have a definitive functional role in mindfulness meditation training and its salutary mechanisms of action, extant empirical evidence is mixed and limited. In the proposed study, we propose to test whether 6 to 7-days mindfulness meditation retreats (N=90), relative to a wait-list control condition (N=45), will impact internal attentional processes or attention to internal experience (e.g., thoughts and bodily sensations); and whether these internal attentional change processes predict salutary outcomes of mindfulness meditation retreats. Participants will complete tasks designed to measure attention to internal experience before and then immediately following the retreat, as well as self-report measures of salutary outcomes before and 2-weeks post-retreat. Matched controls will complete the tasks at parallel time-points in the lab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 14, 2023

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

December 20, 2020

Last Update Submit

February 12, 2023

Conditions

Keywords

Internal attentionInteroceptive attentionMeditationMindfulnessMindfulness Retreat

Outcome Measures

Primary Outcomes (4)

  • Change in Simulated Thought Paradigm - Digit Categorization Task

    The Simulated Thought Paradigm integrated into the Digit Categorization Task will be used to measure change, from pre-intervention to post-intervention, in internal attentional disengagement from simulated negative and neutral self-referential thoughts to a digit categorization (odd or even) task. Attentional disengagement will be computed via difference in reaction time to respond to digit target between negative and neutral self-referential thoughts. A positive score reflects greater difficulty to disengage from negative vs. neutral stimuli.

    pre-intervention, immediately post-intervention

  • Change in Simulated Thought Paradigm - Dichotic 1-Back Task

    The Simulated Thought Paradigm integrated into the Dichotic 1-Back Task will be used to measure change, from pre-intervention to post-intervention, in internal selection between concurrent simulated negative and neutral self-referential thoughts. Biased selective internal attention will be computed via subtracting behavioral responding (e.g., accuracy) between concurrent negative and neutral self-referential thoughts. A positive bias score reflects greater selective attention to negative vs. neutral stimuli.

    pre-intervention, immediately post-intervention

  • Change in Simulated Thought Paradigm - Body Map Task

    The Simulated Thought Paradigm integrated into the Body Map Task will be used to measure change, from pre-intervention to post-intervention, in interoceptive attention via subjective assessment (i.e. sensibility) of the frequency, location, intensity and hedonic tone of bodily sensations, as well as change in emotional experience (5-point Likert scale ranging from 1 to 5), in response to negative and neutral self-referential thoughts.

    pre-intervention, immediately post-intervention

  • Change in Mindful Awareness Task

    The Mindful Awareness Task is a behavioral paradigm will be used to measure change, from pre-intervention to post-intervention, in the objects and temporal dynamics of mindful awareness during mindfulness meditation. MAT scores include meta-awareness, quantified as the frequency of meta-awareness (i.e., awareness of the processes in consciousness); mindful awareness of body, mind, thoughts, pleasant and unpleasant hedonic tone, quantified as the frequency of mindful awareness of these experiential objects; mindful awareness time, quantified as the amount of time each participant engages in mindful awareness (in seconds); sustained mindful awareness, quantified as the average amount of time each participant sustains mindful-awareness without significant interruptions (in seconds); and latency to re-engagement in mindful awareness, quantified as the average amount of time it takes each participant to re-engage in mindful awareness following the onset of mindless states (in seconds).

    pre-intervention, 0-2 days post-intervention

Secondary Outcomes (22)

  • Change in Well-Being Index (WHO-5)

    pre-intervention, 2-weeks post-intervention

  • Change in Overall Anxiety Severity and Impairment Scale (OASIS)

    pre-intervention, 2-weeks post-intervention

  • Change in Patient Health Questionnaire (PHQ-9)

    pre-intervention, 2-weeks post-intervention

  • Change in Perseverative Thinking Questionnaire (PTQ)

    pre-intervention, 2-weeks post-intervention

  • Change in Mind Wandering Questionnaire (MWQ)

    pre-intervention, 2-weeks post-intervention

  • +17 more secondary outcomes

Other Outcomes (1)

  • Previous Meditation Experience Interview

    pre-intervention

Study Arms (2)

Mindfulness Meditation Retreat

6 to 7-days mindfulness meditation retreat

Behavioral: Mindfulness meditation retreat

No intervention, Matched control

Adults participants will be recruited from social media and local community of meditation practitioners, and will be matched to the retreat group by gender, age and level of experience in meditation.

Interventions

6 to 7-days mindfulness retreat (Vipassana/insight meditation). The retreats are held in silence and led by senior teachers with many years of experience in teaching meditation. The focus of the retreat is the practice of mindfulness meditation while sitting and walking. Retreats include focused attention and open monitoring mindfulness meditation practices. Each retreat has a similar practice schedule thus the amount and nature of formal practice is mostly the same.

Mindfulness Meditation Retreat

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults from the general population and the local community of meditation practitioners.

You may qualify if:

  • Retreat Group: Adults who register to participate in a 6 to 7-days mindfulness meditation retreats.
  • Control Group: Adults participants will be recruited from social media and local community of meditation practitioners, and will be matched to the retreat group by gender, age and level of experience in meditation.

You may not qualify if:

  • Younger than 18 years-old and older than 65-years.
  • Have first language other than Hebrew.
  • Self-report lack of fluency in speaking or understanding Hebrew-language.
  • Not having access to a computer and headphones with a microphone (for completing behavioral tasks).
  • Participation in a retreat 1 month before the first primary outcomes assessment or during the weeks between the second primary outcomes assessment and the 2-weeks follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amutat Tovana

Afula, 1933500, Israel

Location

Related Publications (1)

  • Hadash Y, Veksler T, Dar O, Oren-Schwartz R, Bernstein A. Peak experiences during insight mindfulness meditation retreats and their salutary and adverse impact: A prospective matched-controlled intervention study. J Consult Clin Psychol. 2024 Apr;92(4):213-225. doi: 10.1037/ccp0000875.

Study Officials

  • Amit Bernstein, Ph.D.

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

February 11, 2021

Study Start

August 1, 2020

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

February 14, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations