NCT05353231

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 25, 2022

Last Update Submit

May 22, 2022

Conditions

Keywords

Cognitive ChangeInternal attentionInteroceptive attentionMeditationMindfulnessComputerized interventionAttentional bias

Outcome Measures

Primary Outcomes (1)

  • 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.

    pre-intervention, immediately post-intervention

Secondary Outcomes (4)

  • STP-One-Back Dichotic Listening Task

    immediately post-intervention

  • STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes

    immediately post-intervention

  • Change in the STP-Emotional Reactivity Task

    pre-intervention, immediately post-intervention

  • Change in the STP-Body Map Task

    pre-intervention, immediately post-intervention

Study Arms (3)

Intervention 1 - Attention Feedback Awareness and Control Training

EXPERIMENTAL
Behavioral: Attention Feedback Awareness and Control Training (A-FACT)

Intervention 2 - Mindful Disengagement from Thoughts Training

EXPERIMENTAL
Behavioral: Mindful Disengagement from Thoughts Training (MDTT)

Placebo

PLACEBO COMPARATOR
Behavioral: Placebo-Control

Interventions

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 1 - Attention Feedback Awareness and Control Training

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 2 - Mindful Disengagement from Thoughts Training
Placebo-ControlBEHAVIORAL

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.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Brooding subscale in the Ruminative Responses Scale (RRS) - with score equal to or greater than 11

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 31905, Israel

RECRUITING

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Study Officials

  • Amit Bernstein, Ph.D.

    University of Haifa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Bernstein, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

May 23, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-04

Data Sharing

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

Locations