Attention ImpairedNCT04749264
The Influence of Mindfulness Meditation Retreat on Attention to Internal Experience
An observational study of Attention Impaired and Cognitive Change, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Impaired, Cognitive Change, Mental Health Issue
- What is being tested?
- Mindfulness meditation retreat
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 142 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 1 Jun 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults from the general population and the local community of meditation practitioners.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Broadly, the investigators first aim is to assess whether mindfulness meditation retreat will yield significant improvement at post-relative to pre-retreat, compared to matched control, in each of these internal attentional processes: (i) enhanced ability to disengage from negative self-referential thoughts; (ii) reduced selection bias to negative self-referential thoughts; (iii) enhanced interoceptive attention and sensibility to a broader range of locations, intensities and hedonic tones of bodily sensations in response to negative and neutral self-referential thoughts; as well as (iv) enhanced mindful awareness during mindfulness meditation as expressed in the objects and temporal dynamics of mindful awareness. Second, the investigators will assess whether each of the aforementioned internal attentional change processes from pre- to post-retreat, will predict change from pre- to 2-weeks post-retreat in mindful awareness in daily living, mindfulness-related processes (e.g., decentering), and mental health. Third, investigators will assess whether previous meditation experience moderates these effects.
- Conditions
- Attention Impaired, Cognitive Change, Mental Health Issue
- Being tested
- Mindfulness meditation retreat
- Keywords
- Internal attention, Interoceptive attention, Meditation, Mindfulness, Mindfulness Retreat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation retreatBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Retreat | 6 to 7-days mindfulness meditation retreat Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: pre-intervention, 0-2 days post-intervention
Secondary outcomes (22)
Change in Well-Being Index (WHO-5)
WHO-5 is a 5-item self-report questionnaire measuring well-being (6-point Likert scale ranging from 0 to 5) with higher scores indicating greater quality of life. The total score is the sum of all 5 items multiplied by 4 to create a score the ranges from 0 to 100. WHO will be used to measure change, from pre-to post-intervention, in well-being.
Measured: pre-intervention, 2-weeks post-intervention
Change in Overall Anxiety Severity and Impairment Scale (OASIS)
OASIS is a 5-item self-report questionnaire measuring anxiety symptom severity (5-point Likert scale ranging from 0 to 4) with higher scores indicating greater anxiety-related severity and impairment. The total score is the sum of all 5 items, and ranges from 0 to 20. OASIS will be used to measure change, from pre-to post-intervention, in anxiety.
Measured: pre-intervention, 2-weeks post-intervention
Change in Patient Health Questionnaire (PHQ-9)
PHQ-9 is a 9-item self-report questionnaire measuring depression symptom severity (4-point Likert scale ranging from 0 to 3) with higher scores indicating greater depression symptom severity. The total score is the sum of all 9 items, and ranges from 0 to 27. PHQ-9 will be used to measure change, from pre-to post-intervention, in depression.
Measured: pre-intervention, 2-weeks post-intervention
Change in Perseverative Thinking Questionnaire (PTQ)
PTQ is a 15-items self-report questionnaire to measuring negative thinking that is repetitive, unproductive, difficult to disengage from and that captures mental capacity (5-point Likert-scale ranging from 0 to 4) with higher scores indicating greater repetitive thinking. The total score is the sum of all 15 items, and ranges from 0 to 60. PTQ will be used to measure change, from pre-to post-intervention, in negative repetitive thinking.
Measured: pre-intervention, 2-weeks post-intervention
Change in Mind Wandering Questionnaire (MWQ)
MWQ is a 5-item self-report questionnaire measuring levels of mind-wandering (6-point Likert scale ranging from 1 to 6) with higher scores indicating greater levels of mind wandering. The total score is the sum of all 5 items, and ranges from 5 to 30. MWQ will be used to measure change, from pre-to post-intervention, in mind-wandering.
Measured: pre-intervention, 2-weeks post-intervention
Change in Rumination Response Scale (RRS) - Brooding subscale
The brooding subscale of the RRS is a 5-items self-report questionnaire measuring levels of brooding (4-point Likert scale ranging from 1 to 4) with higher scores indicating greater levels of brooding. The total score is the sum of all 5 items, and ranges from 5 to 20. RRS will be used to measure change, from pre-to post-intervention, in rumination/brooding.
Measured: pre-intervention, 2-weeks post-intervention
Change in The Five Facets Mindfulness Questionnaire (FFMQ)
FFMQ is a 39-item self-report questionnaire measuring 5 facets of trait mindfulness (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater levels of trait mindfulness. The FFMQ includes 5 subscales measuring facets of mindfulness: observing, describing, acting with awareness, non-judging of experience, and non-reactivity to inner experience. Each subscale score is the sum of its items. FFMQ will be used to measure change, from pre-to post-intervention, in facets of trait mindfulness.
Measured: pre-intervention, 2-weeks post-intervention
Change in The Multidimensional Assessment of Interoceptive Awareness (MAIA)
MAIA is a 32 -item self-report questionnaire measuring 8 dimensions of interoceptive awareness (6-point Likert scale ranging from 0 to 5) with higher scores indicating greater levels of interoceptive awareness. The MAIA includes 8 subscales measuring dimensions of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Each subscale score is the sum of its items. MAIA will be used to measure change, from pre-to post-intervention, in dimensions of interoceptive awareness.
Measured: pre-intervention, 2-weeks post-intervention
Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S)
SOCS-S is a 20-item self-report questionnaire measuring 5 different dimensions of self-compassion (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater levels of self-compassion. The SOCS-S includes 5 subscales measuring dimensions of self-compassion: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating uncomfortable feelings, and motivation to act/acting to alleviate suffering. Each subscale score is the sum of its items. SOC-S will be used to measure change, from pre-to post-intervention, in dimensions of self-compassion.
Measured: pre-intervention, 2-weeks post-intervention
Change in Metacognitive Processes of Decentering Scale - Trait (MPod-t)
MPod-t is a 15-item self-report questionnaire measuring trait levels of the 3 metacognitive processes of decentering (5-point Likert scale ranging from 1 to 5), with higher scores indicating greater levels of decentering. The MPoD-t includes 3 subscales measuring the metacognitive processes of decentering: meta-awareness, disidentification from internal experience, and non-reactivity to internal experience. Each subscale score is the sum of its items. MPod-t will be used to measure change, from pre-to post-intervention, in the metacognitive processes of decentering.
Measured: pre-intervention, 2-weeks post-intervention
Change in The 7-Item Nonattachment Scale (NAS-7)
NAS-7 is a 7-item self-report questionnaire measuring nonattachment (6-point Likert scale ranging from 1 to 6) with higher scores indicating greater levels of nonattachment. The total score is the sum of all 7 items, and ranges from 7 to 42. NAS-7 will be used to measure change, from pre-to post-intervention, in nonattachment.
Measured: pre-intervention, 2-weeks post-intervention
Change in The 16 item Difficulties in Emotion Regulation Scale (DERS-16)
DERS is a 16-item self-report questionnaire measuring 5 dimensions of difficulties in emotion regulation (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater difficulties with emotion regulation. The DERS-16 includes 5 subscales measuring dimensions of difficulties in emotion regulation: lack of emotional clarity, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to effective emotion regulation strategies, nonacceptance of emotional responses. Each subscale score is the sum of its items. DERS-16 will be used to measure change, from pre-to post-intervention, in difficulties in emotion regulation.
Measured: pre-intervention, 2-weeks post-intervention
Change in Trait International - Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
The trait I-PANAS-SF is a 10-item self-report questionnaire measuring trait positive and negative affect (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater positive and negative affect. The I-PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items. PANAS-SF will be used to measure change, from pre-to post-intervention, in negative and positive affect.
Measured: pre-intervention, 2-weeks post-intervention
Change in State Mindfulness Scale (SMS)
SMS is a 21-item self-report questionnaire measuring state mindful awareness of body and mind (5-point Likert-type scale ranging from 1 to 5) during the MAT mindfulness meditation, with higher scores indicating greater state mindfulness. The SMS total score is the sum of all 21 items, and ranges from 21 to 105. It includes 2 subscales, one measuring mindful awareness of body and the other measuring mindful awareness of mind. Each subscale score is the sum of its items. SMS will be used to measure change, from pre-to post-intervention, in state mindfulness during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Toronto Mindfulness Scale - Curiosity subscale (TMS-C)
The curiosity subscale subscale of the TMS is a 6-item self-report questionnaire measuring state curiosity towards present moment experience (5-point Likert-type scale ranging from 0 to 4) during the MAT mindfulness meditation, with higher scores indicating greater state curiosity. The TMS-C score is the sum of all 6 items, and ranges from 0 to 24. TMS-C will be used to measure change, from pre-to post-intervention, in state curiosity during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Metacognitive Processes of Decentering Scale - State (MPod-s)
MPod-s is a 3-item self-report questionnaire measuring state levels of the 3 metacognitive processes of decentering (11-point Likert scale ranging from 0 to 10) with higher scores indicating greater levels of decentering (minimum scale score 0 and maximum scale score 10). Each of the 3 MPoD-s items measures a metacognitive process of decentering: meta-awareness, disidentification from internal experience, and non-reactivity to internal experience. MPod-s will be used to measure change, from pre-to post-intervention, in state decentering during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in State International - Positive and Negative Affect Schedule - Short Form (State I-PANAS-SF)
State I-PANAS-SF is a 10-item self-report questionnaire measuring state positive and negative affect (5-point Likert scale ranging from 1 to 5) during the MAT mindfulness meditation, with higher scores indicating greater state positive and negative affect. The I-PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items. State I-PANAS-SF will be used to measure change, from pre-to post-intervention, in state positive and negative affect during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Mindful Awareness During Meditation
11 experience sampling item measuring the following mindful awareness processes (9-point Likert scale ranging from 1 to 9) during the MAT mindfulness meditation: mindful awareness of the breath, body, mind, pleasant and unpleasant hedonic tone, as well as meta-awareness, mindful awareness time, sustained mindful awareness, and latency to re-engagement in mindful awareness, and mindful awareness of change. Higher scores indicate greater levels of mindful awareness. Experience sampling will be used to measure change, from pre-to post-intervention, in state mindful awareness processes during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Attitudinal Qualities of Mindfulness During Meditation
9 experience sampling item measuring the following attitudinal qualities of mindful awareness (9-point Likert scale ranging from 1 to 9) during the MAT mindfulness meditation: curiosity about bodily and mental experience, distance and (dis)Identification with internal experience, hedonic-based desire of pleasant and unpleasant experience (non-equanimity), willingness, and experiential avoidance. Higher scores indicate greater levels of each attitudinal quality. Experience sampling will be used to measure change, from pre-to post-intervention, in attitudinal qualities of mindful awareness during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Phenomenological States During Meditation
9 experience sampling item measuring the following phenomenological states (9-point Likert scale ranging from 1 to 9) during the MAT mindfulness meditation: fatigue, alertness, falling asleep, effort, boredom, enjoyment, relaxation, and mind-wandering frequency and duration. Higher scores indicate greater levels of each phenomenological state. Experience sampling will be used to measure change, from pre-to post-intervention, in phenomenological states during the MAT mindfulness meditation.
Measured: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Peak Meditative Experience Scale (PMES)
PMES is a 32-item self-report questionnaire measuring the occurrence of 32 types of peak experiences (unusual and uncommon experiences) during the retreat/last week ("yes" or "no"), their frequencies (open ended number), duration (open ended number), and degree of hedonic tone (9-point Likert scale ranging from -4 to +4). Positive hedonic tone scores indicate pleasant hedonic tone, zero scores indicate neutral hedonic tone, negative scores indicate unpleasant hedonic tone. The PMES items relate to 6 domains of peak experiences: positive emotions, negative emotions, perception, altered states of consciousness, dissociation, and insight.
Measured: 0-2 days post-intervention
Impact of Peak Meditative Experience Scale (I-PMES)
I-PMES is a self-report questionnaire measuring the positive and negative impact of peak experiences that participants had during the retreat, on participant's lives after the retreat (two 5-point Likert scales for each experience: positive impact ranging from 0 to +4, negative impact ranging from 0 to -4). The number of items in this scale varies between participants as they are only asked to rate the impact of peak experiences they indicated in the PMES that they had during the retreat. Only participants in the mindfulness meditation retreat condition will complete this measure.
Measured: 2-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention ImpairedStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Bernstein, Ph.D., Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749264
- Sponsor's protocol ID
- TOVANA
- Status last verified
- Jan 2021
- First submitted
- 20 Dec 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hadash Y, Dar O, Oren-Schwartz R, Bernstein A. The effects of intensive mindfulness meditation training on mental health: evidence of effectiveness and safety from a matched-controlled intervention study. Cogn Behav Ther. 2026 Apr 29:1-14. doi: 10.1080/16506073.2026.2656720. Online ahead of print.
PubMed 42053192Hadash 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.
PubMed 38573713
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mindfulness Meditation Retreat on Attention to Internal Experience
- ClinicalTrials.gov ID
- NCT04749264
- Acronym / sponsor ID
- TOVANA
- Conditions
- Attention Impaired, Cognitive Change, Mental Health Issue
- Keywords
- Internal attention, Interoceptive attention, Meditation, Mindfulness, Mindfulness Retreat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Feb 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.
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.
Detailed description
Broadly, the investigators first aim is to assess whether mindfulness meditation retreat will yield significant improvement at post-relative to pre-retreat, compared to matched control, in each of these internal attentional processes: (i) enhanced ability to disengage from negative self-referential thoughts; (ii) reduced selection bias to negative self-referential thoughts; (iii) enhanced interoceptive attention and sensibility to a broader range of locations, intensities and hedonic tones of bodily sensations in response to negative and neutral self-referential thoughts; as well as (iv) enhanced mindful awareness during mindfulness meditation as expressed in the objects and temporal dynamics of mindful awareness. Second, the investigators will assess whether each of the aforementioned internal attentional change processes from pre- to post-retreat, will predict change from pre- to 2-weeks post-retreat in mindful awareness in daily living, mindfulness-related processes (e.g., decentering), and mental health. Third, investigators will assess whether previous meditation experience moderates these effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Retreat | – | Behavioral: Mindfulness meditation retreat6 to 7-days 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults from the general population and the local community of meditation practitioners.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Mindfulness meditation retreat6 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. | Behavioural | Mindfulness Meditation Retreat |
Primary outcome
Change in Simulated Thought Paradigm - Digit Categorization Task
Time frame: pre-intervention, immediately post-intervention
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.
Change in Simulated Thought Paradigm - Dichotic 1-Back Task
Time frame: pre-intervention, immediately post-intervention
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.
Change in Simulated Thought Paradigm - Body Map Task
Time frame: pre-intervention, immediately post-intervention
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.
Change in Mindful Awareness Task
Time frame: pre-intervention, 0-2 days post-intervention
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).
22 secondary outcomes
Change in Well-Being Index (WHO-5)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Patient Health Questionnaire (PHQ-9)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Perseverative Thinking Questionnaire (PTQ)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Mind Wandering Questionnaire (MWQ)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Rumination Response Scale (RRS) - Brooding subscale
Time frame: pre-intervention, 2-weeks post-intervention
Change in The Five Facets Mindfulness Questionnaire (FFMQ)
Time frame: pre-intervention, 2-weeks post-intervention
Change in The Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Metacognitive Processes of Decentering Scale - Trait (MPod-t)
Time frame: pre-intervention, 2-weeks post-intervention
Change in The 7-Item Nonattachment Scale (NAS-7)
Time frame: pre-intervention, 2-weeks post-intervention
Change in The 16 item Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: pre-intervention, 2-weeks post-intervention
Change in Trait International - Positive and Negative Affect Schedule - Short Form (I-PANAS-SF)
Time frame: pre-intervention, 2-weeks post-intervention
Change in State Mindfulness Scale (SMS)
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Toronto Mindfulness Scale - Curiosity subscale (TMS-C)
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Metacognitive Processes of Decentering Scale - State (MPod-s)
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in State International - Positive and Negative Affect Schedule - Short Form (State I-PANAS-SF)
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Mindful Awareness During Meditation
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Attitudinal Qualities of Mindfulness During Meditation
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Change in Experience Sampling of Phenomenological States During Meditation
Time frame: immediately after MAT administration pre-intervention, immediately after MAT administration post-intervention
Peak Meditative Experience Scale (PMES)
Time frame: 0-2 days post-intervention
Impact of Peak Meditative Experience Scale (I-PMES)
Time frame: 2-weeks post-intervention
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 14 Feb 2023.
- Derived from this study: PubMed 42053192Hadash Y, Dar O, Oren-Schwartz R, Bernstein A. The effects of intensive mindfulness meditation training on mental health: evidence of effectiveness and safety from a matched-controlled intervention study. Cogn Behav Ther. 2026 Apr 29:1-14. doi: 10.1080/16506073.2026.2656720. Online ahead of print.
- Derived from this study: PubMed 38573713Hadash 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.
- Individual participant dataSharing planned: Yes
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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.
Amit Bernstein, Ph.D. principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Impaired and Cognitive Change, run by University of Haifa at 1 site in Israel.
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 2 inclusion and 5 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 14 Feb 2023. 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 Israel. 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 Simulated Thought Paradigm - Digit Categorization Task (time frame: pre-intervention, immediately post-intervention). The study lists 4 primary outcomes in all. 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 NCT04749264, which also lists 2 linked publications.
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 14 Feb 2023.