Brief Mental Training and Internal Attentional Control
Primary Purpose
Attention Impaired, Mental Health Issue, Rumination
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Feedback Awareness and Control Training (A-FACT)
Mindful Disengagement from Thoughts Training (MDTT)
Placebo-Control
Sponsored by
About this trial
This is an interventional basic science trial for Attention Impaired focused on measuring Cognitive Change, Internal attention, Interoceptive attention, Meditation, Mindfulness, Computerized intervention, Attentional bias
Eligibility Criteria
Inclusion Criteria:
- Brooding subscale in the Ruminative Responses Scale (RRS) - with score equal to or greater than 11
Exclusion Criteria:
- Endorsement of suicidal ideation ("Yes" answer to Patient Health Questionnaire - 9 Item
- Psychotic Symptoms, specifically auditory hallucinations
- Self-report lack of fluency in speaking or understanding Hebrew-language
Sites / Locations
- University of HaifaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Intervention 1 - Attention Feedback Awareness and Control Training
Intervention 2 - Mindful Disengagement from Thoughts Training
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in the STP-Digit Categorization Task
The STP-Digit Categorization Task (STP-DCT) will be used to measure change, from pre-intervention to post-intervention, in internal attentional disengagement. Attentional disengagement will be computed by the difference in reaction time on negative relative to neutral simulated thought stimuli as well as via a dynamic bias score calculated by subtracting the running mean of the 8 neutral trials window ( 4 neutral trials backwards and 4 neutral trials forward), from each negative trial reaction time that exceeds the 95%CI., dividing this distance by the 8 neutral trials window standard deviation (Amir, Ruimi, & Bernstein, 2021). A positive score reflects greater difficulty to disengage from negative relative to neutral thought stimuli.
Secondary Outcome Measures
STP-One-Back Dichotic Listening Task
The STP-One-Back Dichotic Listening Task will be used to measure biased selective attention of negative simulated thought stimuli. Biased selective attention will be computed by the difference in accuracy for negative relative to neutral simulated thought stimuli. An accurate response (for each stimulus) is the correct left/right button press for the respective left/right channel in which a repetition of auditory neutral or negative simulated thought stimuli were presented - i.e., the stimulus delivered at trial n-1 was repeated on trial n (in the same channel); or the correct withholding of a response if no repetition was present. A positive bias score reflects greater selective attention to negative relative to neutral thought stimuli.
STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes
The STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes will be used to measure meta-awareness of attentional disengagement from stimulated thoughts stimuli. While performing the STP-DCT task, participants are instructed to, on the trial-level, report when the simulated thought influenced their trial response (i.e., led to difficulty disengaging attention from thought to categorize the digit) by pressing a key immediately following trial response. Meta-awareness will be computed using the Diagnostic Odds Ratio (Ruimi, Hadash, Zvielli, Amir, Goldstein, & Bernstein, 2018). Positive scores reflects degree of meta-awareness for difficulty to disengage from thought stimuli.
Change in the STP-Emotional Reactivity Task
The STP-Emotional Reactivity Task will be used to measure change, from pre- to post-intervention, in emotional reactivity to negative simulated thought stimuli. Emotional reactivity will be computed as the difference between the mean of 5 subjective emotion stats (irritability, anger, anxiety, guilt, distress), each self-rated on a 5-point Likert-type scale, following one block of 20 neutral-, and then again one block of 20 negative- simulated thought stimuli. Positive scores reflect greater emotional reactivity in response to negative relative to neutral thought stimuli.
Change in the STP-Body Map Task
The STP-Body Map Task will be used to measure interoceptive attention via subjective assessment (i.e. sensibility) of bodily sensations, following negative and neutral stimuli (STP). The following interoceptive attention variables will be calculated: (1) Detection of bodily sensations (frequency (number) of bodily sensations); (2) Magnitude of bodily sensations (mean intensity of bodily (range from 1 to 5)); (3) Bias to hedonic tone of bodily sensations (proportion/percent of neutral, pleasant and unpleasant sensations), (4) Bias to central vs peripheral bodily sensations (e.g. proportion/percent of sensations in torso/head vs. legs/arms).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05353231
Brief Title
Brief Mental Training and Internal Attentional Control
Official Title
Brief Mental Training and Internal Attentional Control in Repetitive Negative Thinking: Experimental Laboratory Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Previous research documented that real-time feedback on attention as well as related forms of mental training (e.g. mindfulness meditation) may be used to train and impact external attentional control. These approaches to mental training are designed to train meta-awareness in order to enable attentional control. It is not yet known, however, whether such training targeting meta-awareness can be similarly used to impact internal attentional control. Thus, the investigators will test whether real-time feedback training and a brief mindfulness meditation training, relative to placebo control, will lead to greater internal attentional control among adults with elevated negative repetitive thinking.
Detailed Description
Participants will complete all assessments and training in a single laboratory session. Participants (N=105) with elevated levels of negative repetitive thinking (Rumination Response Scale -Brooding >=11) will be randomly assigned to one of 3 intervention arms: Attention Feedback Awareness and Control Training (A-FACT; n=35), Mindful Disengagement from Thoughts Training (MDTT; n=35), or placebo control (n=35).
At pre- and post-intervention, the investigators will measure: (1) Subjective emotional reactivity in response to negative vs. neutral self-referential thoughts using the Simulated Thought Paradigm (STP)-Emotional Reactivity task; (2) Interoceptive attention (i.e. sensibility) of the subjective location, intensity and hedonic tone of bodily sensations, using the STP-Body Map task, and (3) internal attentional control (i.e. latency to disengage) using the STP-Digit Categorization Task.
At post-intervention assessment only, the investigators will measure: (1) Meta-awareness of internal attentional dyscontrol using the STP-Digit Categorization Task with Self-Caught Probes; (2) internal attentional control (i.e. selective attention) using the STP-One-Back Dichotic Listening Task as a measure of the generalizability of the expected primary effect on internal attentional control.
The primary aim is to test the effect of 2 active intervention arms, Attention Feedback Awareness and Control Training and Mindful Disengagement from Thoughts Training, relative to one another and placebo control, on internal attentional control from pre-to-post training among adults with elevated negative repetitive thinking. The investigators hypothesise that both active interventions conditions will yield improvement in internal attentional control, as measured by the Digit Categorization Task integrated with the Simulated Thoughts Paradigm, from pre-to-post intervention, relative to the placebo-control.
Secondary aims are to test the effects of the 2 active intervention arms, relative to one another and placebo control, on subjective emotional reactivity to negative self-referential thoughts, selection bias to negative self-referential thoughts, meta-awareness of attentional dyscontrol, as well as interoceptive attention to bodily sensations in response to negative self-referential thoughts. The investigators hypothesize that, relative to the control-placebo group, the active intervention groups will yield (a) reduced emotional reactivity to negative self-referential thoughts as measured in the Emotional Reactivity Task, (b) higher levels of meta-awareness of attentional dyscontrol as measured by the STP-Digit Categorization Task with Self-Caught Probes, and (c) higher levels of selective internal attentional control as measured by the STP-One-Back Dichotic Listening Task.
Additionally, the investigators hypothesize that, relative to the placebo control group and the Attention Feedback Awareness and Control Training group, the Mindful Disengagement from Thoughts Training group will yield enhanced interoceptive attention (i.e. sensibility) to a broader range of locations (e.g. peripheral body areas), intensities (e.g. subtle sensations) and hedonic tones (e.g. neutral and pleasant hedonic tones) of bodily sensations in response to self-referential thoughts, as measured by STP-Body Map task.
Finally, the investigators hypothesized non-inferiority between the active intervention groups with respect to all mentioned measured outcomes, with exception of the noted STP-Body-Map Task.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Impaired, Mental Health Issue, Rumination
Keywords
Cognitive Change, Internal attention, Interoceptive attention, Meditation, Mindfulness, Computerized intervention, Attentional bias
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1 - Attention Feedback Awareness and Control Training
Arm Type
Experimental
Arm Title
Intervention 2 - Mindful Disengagement from Thoughts Training
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Attention Feedback Awareness and Control Training (A-FACT)
Intervention Description
A-FACT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control.
Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Following a fixation que, the auditory neutral or negative simulated thought stimulus is delivered, and 500ms prior to termination of the auditory stimulus, a visual stimulus is presented until participants categorize the visual stimulus as greater than or smaller than 5 objects. Latency to disengage attention from each thought stimuli, at the trial-level, is repeatedly measured, and after each negative thought stimulus, trial-level feedback on the latency to disengage is delivered back to participants through a visual scale representing their attentional bias. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Disengagement from Thoughts Training (MDTT)
Intervention Description
MDTT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Participants will first learn and practice a focused attention on the breath meditation. Then, participants will practice pressing a button each time they notice an inhalation or exhalation during the focused attention meditation. Next, during the meditation, participants will be presented the auditory neutral or negative simulated thought stimuli and will train internal attentional control by repeatedly disengaging their attention from these stimuli and back to their breath MDTT will thus entail 80 trials (40 negative, 40 neutral, ITI ≈ 10sec) during the focused attention on the breath meditation.
Intervention Type
Behavioral
Intervention Name(s)
Placebo-Control
Intervention Description
The condition is designed as a placebo control for the Attention Feedback Awareness and Control Training (A-FACT) training condition. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Rather than the quantity categorization task with trial-level feedback, participants only engage in the quantity categorization task. The task is identical in all other ways to the A-FACT condition. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial.
Primary Outcome Measure Information:
Title
Change in the STP-Digit Categorization Task
Description
The STP-Digit Categorization Task (STP-DCT) will be used to measure change, from pre-intervention to post-intervention, in internal attentional disengagement. Attentional disengagement will be computed by the difference in reaction time on negative relative to neutral simulated thought stimuli as well as via a dynamic bias score calculated by subtracting the running mean of the 8 neutral trials window ( 4 neutral trials backwards and 4 neutral trials forward), from each negative trial reaction time that exceeds the 95%CI., dividing this distance by the 8 neutral trials window standard deviation (Amir, Ruimi, & Bernstein, 2021). A positive score reflects greater difficulty to disengage from negative relative to neutral thought stimuli.
Time Frame
pre-intervention, immediately post-intervention
Secondary Outcome Measure Information:
Title
STP-One-Back Dichotic Listening Task
Description
The STP-One-Back Dichotic Listening Task will be used to measure biased selective attention of negative simulated thought stimuli. Biased selective attention will be computed by the difference in accuracy for negative relative to neutral simulated thought stimuli. An accurate response (for each stimulus) is the correct left/right button press for the respective left/right channel in which a repetition of auditory neutral or negative simulated thought stimuli were presented - i.e., the stimulus delivered at trial n-1 was repeated on trial n (in the same channel); or the correct withholding of a response if no repetition was present. A positive bias score reflects greater selective attention to negative relative to neutral thought stimuli.
Time Frame
immediately post-intervention
Title
STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes
Description
The STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes will be used to measure meta-awareness of attentional disengagement from stimulated thoughts stimuli. While performing the STP-DCT task, participants are instructed to, on the trial-level, report when the simulated thought influenced their trial response (i.e., led to difficulty disengaging attention from thought to categorize the digit) by pressing a key immediately following trial response. Meta-awareness will be computed using the Diagnostic Odds Ratio (Ruimi, Hadash, Zvielli, Amir, Goldstein, & Bernstein, 2018). Positive scores reflects degree of meta-awareness for difficulty to disengage from thought stimuli.
Time Frame
immediately post-intervention
Title
Change in the STP-Emotional Reactivity Task
Description
The STP-Emotional Reactivity Task will be used to measure change, from pre- to post-intervention, in emotional reactivity to negative simulated thought stimuli. Emotional reactivity will be computed as the difference between the mean of 5 subjective emotion stats (irritability, anger, anxiety, guilt, distress), each self-rated on a 5-point Likert-type scale, following one block of 20 neutral-, and then again one block of 20 negative- simulated thought stimuli. Positive scores reflect greater emotional reactivity in response to negative relative to neutral thought stimuli.
Time Frame
pre-intervention, immediately post-intervention
Title
Change in the STP-Body Map Task
Description
The STP-Body Map Task will be used to measure interoceptive attention via subjective assessment (i.e. sensibility) of bodily sensations, following negative and neutral stimuli (STP). The following interoceptive attention variables will be calculated: (1) Detection of bodily sensations (frequency (number) of bodily sensations); (2) Magnitude of bodily sensations (mean intensity of bodily (range from 1 to 5)); (3) Bias to hedonic tone of bodily sensations (proportion/percent of neutral, pleasant and unpleasant sensations), (4) Bias to central vs peripheral bodily sensations (e.g. proportion/percent of sensations in torso/head vs. legs/arms).
Time Frame
pre-intervention, immediately post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Brooding subscale in the Ruminative Responses Scale (RRS) - with score equal to or greater than 11
Exclusion Criteria:
Endorsement of suicidal ideation ("Yes" answer to Patient Health Questionnaire - 9 Item
Psychotic Symptoms, specifically auditory hallucinations
Self-report lack of fluency in speaking or understanding Hebrew-language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Bernstein, Ph.D.
Phone
+972-4-828-8871
Email
abernstein@psy.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Bernstein, Ph.D.
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
ZIP/Postal Code
31905
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Bernstein, Ph.D.
Phone
+972-4-828-8871
Email
abernstein@psy.haifa.ac.il
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Brief Mental Training and Internal Attentional Control
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