Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816564
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-02-03
Brief Title:
Optimizing Attentional Bias Modification
Sponsor:
University of Texas at Tyler
Organization:
University of Texas at Tyler
Study Overview
Official Title:
Optimizing Attentional Bias Modification for Depression Does Mindfulness Help
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Depression has been associated with an attention bias towards negative information Attention bias modification ABM interventions explore potential benefits of training attention away from negative or threatening information and towards neutral or positive information The goal of this study is to examine the effectiveness of an ABM intervention that includes a preceding mindfulness training among a sample of individuals who self-reported mild-to-moderately depression symptoms The main question this study aims to answer is
Do individuals who participate in an ABM intervention have a greater reduction in attention bias towards negative information and depressive symptoms when compared to a control group Participants will be asked to participate in 3 days of brief mindfulness training exercises preceding an ABM intervention session that lasts 15 to 2 hours while wearing electroencephalography EEG equipment
Researchers will compare the ABM intervention group to a sham intervention group to see if the ABM intervention reduces negative attention bias above and beyond brief mindfulness training
Do individuals who participate in an ABM intervention have a greater reduction in attention bias towards negative information and depressive symptoms when compared to a control group Participants will be asked to participate in 3 days of brief mindfulness training exercises preceding an ABM intervention session that lasts 15 to 2 hours while wearing electroencephalography EEG equipment
Researchers will compare the ABM intervention group to a sham intervention group to see if the ABM intervention reduces negative attention bias above and beyond brief mindfulness training
Detailed Description:
Approximately 50 participants who have self-reported mild-to-moderate levels of depression will be invited to participate in the study They will be asked to participate over the course of 3 days On the first day informed consent will be reviewed the participant will be asked a series of survey questions and asked to begin the first mindfulness exercise On the second day the participant will be asked to complete a second mindfulness exercise on their own On the third day the participant will be asked to complete a final mindfulness exercise and then to participate in an ABM intervention session while wearing EEG equipment to monitor brain waveforms and extract event-related potentials ERPs
The mindfulness activities used for this study were developed for individuals with depression symptoms The initial activity will consist of introduction to mindfulness with a brief breathing activity developed specifically for individuals suffering from depression symptoms Participants will complete the first mindfulness activity 2 days prior to their ABM session the second activity the day before and refresher activity immediately preceding their ABM intervention During the ABM intervention session participants will complete a pre- and post-intervention dot-probe task DPT to assess for the presence of attention bias before and after the intervention The pre- and post-tasks will consist of trials displaying a fixation cross for 500 ms followed by two faces happy or sad displayed with neutral on the left and right side of visual space for 2000 ms These images are selected from the racially diverse affective expression RADIATE face stimulus set and randomized Once the faces are displayed after a probe single asterisk or double asterisks will appear in the same location as one of the faces Probes will replace an emotional or neutral face with equal frequency Participants will respond to the probe by indicating the number of asterisks they saw using a designated key The task will consist of 192 trials two blocks of 96 trials with 12 pairs of sad and neutral images and 12 pairs of happy and neutral images randomly presented eight times Stimuli used in pre- and post-tasks are different from stimuli used during training Emotional stimuli will be matched on valence and arousal in the two task sets ABM intervention consists of paired positive and negative images and faces Twenty-two images are presented in nine blocks for a total of 198 trials A fixation cross is presented in the middle of the screen for 1500 ms followed by a positive and negative image pair for 4000 ms Each type of stimulus will appear with equal probability and pairings are randomized For the experimental group probes single or double asterisks will follow the positive stimulus 100 of the time For the control group the probe will follow the positive stimulus 50 of the time Participants will indicate how many asterisks they saw using the indicated key Participants will be offered breaks after every two blocks to reduce fatigue
It is expected that individuals who participated in the ABM intervention will demonstrate a more prominent decrease in a negative AB and reduction of depression symptoms when compared to the sham group Outcome measures of this project include reaction time data from ABM intervention task ERP data from EEG data and self-report data collected at the beginning and end of the study Self-report measures used to assess for depression symptoms include the MASQ and Patient Health Questionnaire 9-item PHQ-9 The PHQ-9 a criteria-based measure used to help diagnose depressive disorders It was found to be a reliable and valid measure of depression severity and includes a specific item about trouble concentrating A 4-week follow-up survey with the PHQ-9 will also be sent to participants to assess for any symptom changes at that time Reaction time RT will be used to assess attention bias with faster RT to probes following stimuli with emotion interpreted as attention bias towards that emotion ERP measures are considered objective measuring the time course of attention and are expected to support decreased AB towards negative information
The mindfulness activities used for this study were developed for individuals with depression symptoms The initial activity will consist of introduction to mindfulness with a brief breathing activity developed specifically for individuals suffering from depression symptoms Participants will complete the first mindfulness activity 2 days prior to their ABM session the second activity the day before and refresher activity immediately preceding their ABM intervention During the ABM intervention session participants will complete a pre- and post-intervention dot-probe task DPT to assess for the presence of attention bias before and after the intervention The pre- and post-tasks will consist of trials displaying a fixation cross for 500 ms followed by two faces happy or sad displayed with neutral on the left and right side of visual space for 2000 ms These images are selected from the racially diverse affective expression RADIATE face stimulus set and randomized Once the faces are displayed after a probe single asterisk or double asterisks will appear in the same location as one of the faces Probes will replace an emotional or neutral face with equal frequency Participants will respond to the probe by indicating the number of asterisks they saw using a designated key The task will consist of 192 trials two blocks of 96 trials with 12 pairs of sad and neutral images and 12 pairs of happy and neutral images randomly presented eight times Stimuli used in pre- and post-tasks are different from stimuli used during training Emotional stimuli will be matched on valence and arousal in the two task sets ABM intervention consists of paired positive and negative images and faces Twenty-two images are presented in nine blocks for a total of 198 trials A fixation cross is presented in the middle of the screen for 1500 ms followed by a positive and negative image pair for 4000 ms Each type of stimulus will appear with equal probability and pairings are randomized For the experimental group probes single or double asterisks will follow the positive stimulus 100 of the time For the control group the probe will follow the positive stimulus 50 of the time Participants will indicate how many asterisks they saw using the indicated key Participants will be offered breaks after every two blocks to reduce fatigue
It is expected that individuals who participated in the ABM intervention will demonstrate a more prominent decrease in a negative AB and reduction of depression symptoms when compared to the sham group Outcome measures of this project include reaction time data from ABM intervention task ERP data from EEG data and self-report data collected at the beginning and end of the study Self-report measures used to assess for depression symptoms include the MASQ and Patient Health Questionnaire 9-item PHQ-9 The PHQ-9 a criteria-based measure used to help diagnose depressive disorders It was found to be a reliable and valid measure of depression severity and includes a specific item about trouble concentrating A 4-week follow-up survey with the PHQ-9 will also be sent to participants to assess for any symptom changes at that time Reaction time RT will be used to assess attention bias with faster RT to probes following stimuli with emotion interpreted as attention bias towards that emotion ERP measures are considered objective measuring the time course of attention and are expected to support decreased AB towards negative information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None