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Optimizing Attentional Bias Modification

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification (ABM) for depression
Sham Attention Bias Modification (ABM)
Sponsored by
University of Texas at Tyler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Attention Bias, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years of age. Report of mild-to-moderate levels of depression symptoms. Must be able to read and understand English. Exclusion Criteria: Under the age of 18 years old. Diagnosed with ADHD. Diagnosed with dyslexia. Diagnosed with multiple sclerosis. Diagnosed with a seizure disorder/epilepsy. History of a traumatic brain injury. Currently pregnant. Unable to read and understand English. Difficulty seeing and hearing instructions on a computer. Endorsement of current substance abuse problem. Having a history of electro-shock therapy. Reporting having a medication change in the previous 3-months.

Sites / Locations

  • The University of Texas at TylerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo/Control Group

Arm Description

This is group that will receive the attention bias modification intervention that is programmed to train attention to positive stimuli 100% of the time. Both groups will receive the preceding 3-day brief mindfulness training.

This is group that will receive the "sham" attention bias modification intervention that is programmed to train attention to positive stimuli 50% of the time. Both groups will receive the preceding 3-day brief mindfulness training.

Outcomes

Primary Outcome Measures

Amplitude changes (in microvolts) for scalp-recorded event-related potential (ERP) data.
ERP data will be captured using Brain Vision software and BrainVision actiCHamp 32channel EEG system. ERP measures are considered objective; measuring the time course of attention and are expected to support decreased AB towards negative information (specifically the P300 and N2pc components).
Reaction Time (RT)
Reaction time will be collected and used via E-Prime software with a Chronos button box. Reaction time (RT) data is the primary behavioral data used to assess attention bias in ABM research. In the present study, RT will be used to assess attention bias with faster RT to probes following stimuli with emotion interpreted as attention bias.
Patient Health Questionnaire- 9-item
Patient Health Questionnaire- 9-item (PHQ-9) is a self-report assessment used to measure depression symptoms and their severity. Higher scores on the PHQ-9 indicate higher levels of depression symptoms.
Patient Health Questionnaire- 9-item
Patient Health Questionnaire- 9-item (PHQ-9) is a self-report assessment used to measure depression symptoms and their severity. Higher scores on the PHQ-9 indicate higher levels of depression symptoms.
Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
The Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale (MASQ-AD8) is a self-report assessment used to measure symptoms of anhedonic depression. Higher scores are indicative of higher levels of anhedonic depression.
Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
The Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale (MASQ-AD8) is a self-report assessment used to measure symptoms of anhedonic depression. Higher scores are indicative of higher levels of anhedonic depression.
Ruminative Responses Scale-8 item
Ruminative Responses Scale-8 item is commonly used to measure people's general tendency to ruminate. Higher scores suggest higher levels of rumination.
Ruminative Responses Scale-8 item
Ruminative Responses Scale-8 item is commonly used to measure people's general tendency to ruminate. Higher scores suggest higher levels of rumination.

Secondary Outcome Measures

Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale (MASQ-AA) is a self-report assessment used to measure levels of anxious arousal symptoms. Higher scores on this measure indicate higher levels of anxious arousal.
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale (MASQ-AA) is a self-report assessment used to measure levels of anxious arousal symptoms. Higher scores on this measure indicate higher levels of anxious arousal.
Penn State Worry Questionnaire
Penn State Worry Questionnaire is a self-report assessment used to measure symptoms of anxious apprehension. Higher scores on this measure indicate higher levels of anxious apprehension or worry.
Penn State Worry Questionnaire
Penn State Worry Questionnaire is a self-report assessment used to measure symptoms of anxious apprehension. Higher scores on this measure indicate higher levels of anxious apprehension or worry.
Cognitive and Affective Mindfulness Scale- Revised
Cognitive and Affective Mindfulness Scale- Revised is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Cognitive and Affective Mindfulness Scale- Revised
Cognitive and Affective Mindfulness Scale- Revised is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.

Full Information

First Posted
February 3, 2023
Last Updated
April 3, 2023
Sponsor
University of Texas at Tyler
Collaborators
Psi Chi, Sarah Sass, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05816564
Brief Title
Optimizing Attentional Bias Modification
Official Title
Optimizing Attentional Bias Modification for Depression: Does Mindfulness Help?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Tyler
Collaborators
Psi Chi, Sarah Sass, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 1.5 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 1,500 ms followed by a positive and negative image pair for 4,000 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Attention Bias, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to positive attention training or "sham" attention training but will both receive mindfulness exercises.
Masking
Participant
Masking Description
Participants will be debriefed after study but are not specifically told that they were recruited due to reported depression symptoms.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
This is group that will receive the attention bias modification intervention that is programmed to train attention to positive stimuli 100% of the time. Both groups will receive the preceding 3-day brief mindfulness training.
Arm Title
Placebo/Control Group
Arm Type
Placebo Comparator
Arm Description
This is group that will receive the "sham" attention bias modification intervention that is programmed to train attention to positive stimuli 50% of the time. Both groups will receive the preceding 3-day brief mindfulness training.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification (ABM) for depression
Intervention Description
Both groups will be asked to engage in mindfulness activities but only one group will receive the train-positive ABM task. The control group will receive a "sham" task that is not programmed to train attention towards positive stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Sham Attention Bias Modification (ABM)
Intervention Description
The sham intervention will be given to the control group (but they will still receive mindfulness exercises).
Primary Outcome Measure Information:
Title
Amplitude changes (in microvolts) for scalp-recorded event-related potential (ERP) data.
Description
ERP data will be captured using Brain Vision software and BrainVision actiCHamp 32channel EEG system. ERP measures are considered objective; measuring the time course of attention and are expected to support decreased AB towards negative information (specifically the P300 and N2pc components).
Time Frame
Changes in ERP amplitudes from the baseline attention task to the final attention task on day 3 of the study.
Title
Reaction Time (RT)
Description
Reaction time will be collected and used via E-Prime software with a Chronos button box. Reaction time (RT) data is the primary behavioral data used to assess attention bias in ABM research. In the present study, RT will be used to assess attention bias with faster RT to probes following stimuli with emotion interpreted as attention bias.
Time Frame
Changes in RT from the baseline attention task to the final attention task on day 3 of the study.
Title
Patient Health Questionnaire- 9-item
Description
Patient Health Questionnaire- 9-item (PHQ-9) is a self-report assessment used to measure depression symptoms and their severity. Higher scores on the PHQ-9 indicate higher levels of depression symptoms.
Time Frame
Change from baseline depression symptoms (day 1 of study) to immediately after the 3-day intervention.
Title
Patient Health Questionnaire- 9-item
Description
Patient Health Questionnaire- 9-item (PHQ-9) is a self-report assessment used to measure depression symptoms and their severity. Higher scores on the PHQ-9 indicate higher levels of depression symptoms.
Time Frame
Change from baseline depression symptoms (day 1 of study) to 4-weeks post-intervention.
Title
Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
Description
The Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale (MASQ-AD8) is a self-report assessment used to measure symptoms of anhedonic depression. Higher scores are indicative of higher levels of anhedonic depression.
Time Frame
Change from baseline anhedonic depression symptoms (day 1 of study) to immediately after the 3-day intervention.
Title
Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
Description
The Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale (MASQ-AD8) is a self-report assessment used to measure symptoms of anhedonic depression. Higher scores are indicative of higher levels of anhedonic depression.
Time Frame
Change from baseline anhedonic depression symptoms (day 1 of study) to 4-weeks post-intervention.
Title
Ruminative Responses Scale-8 item
Description
Ruminative Responses Scale-8 item is commonly used to measure people's general tendency to ruminate. Higher scores suggest higher levels of rumination.
Time Frame
Change from baseline rumination levels (day 1 of study) to immediately after the 3-day intervention.
Title
Ruminative Responses Scale-8 item
Description
Ruminative Responses Scale-8 item is commonly used to measure people's general tendency to ruminate. Higher scores suggest higher levels of rumination.
Time Frame
Change from baseline rumination levels (day 1 of study) to 4-weeks post-intervention.
Secondary Outcome Measure Information:
Title
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
Description
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale (MASQ-AA) is a self-report assessment used to measure levels of anxious arousal symptoms. Higher scores on this measure indicate higher levels of anxious arousal.
Time Frame
Change from baseline anxious arousal symptoms (day 1 of study) to immediately after the 3-day intervention.
Title
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
Description
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale (MASQ-AA) is a self-report assessment used to measure levels of anxious arousal symptoms. Higher scores on this measure indicate higher levels of anxious arousal.
Time Frame
Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.
Title
Penn State Worry Questionnaire
Description
Penn State Worry Questionnaire is a self-report assessment used to measure symptoms of anxious apprehension. Higher scores on this measure indicate higher levels of anxious apprehension or worry.
Time Frame
Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.
Title
Penn State Worry Questionnaire
Description
Penn State Worry Questionnaire is a self-report assessment used to measure symptoms of anxious apprehension. Higher scores on this measure indicate higher levels of anxious apprehension or worry.
Time Frame
Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.
Title
Cognitive and Affective Mindfulness Scale- Revised
Description
Cognitive and Affective Mindfulness Scale- Revised is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Time Frame
Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Title
Cognitive and Affective Mindfulness Scale- Revised
Description
Cognitive and Affective Mindfulness Scale- Revised is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Time Frame
Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Title
Five Facet Mindfulness Questionnaire
Description
Five Facet Mindfulness Questionnaire is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Time Frame
Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Title
Five Facet Mindfulness Questionnaire
Description
Five Facet Mindfulness Questionnaire is a self-report assessment that measures levels of mindfulness. Higher scores on this measure indicate higher levels of mindfulness.
Time Frame
Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age. Report of mild-to-moderate levels of depression symptoms. Must be able to read and understand English. Exclusion Criteria: Under the age of 18 years old. Diagnosed with ADHD. Diagnosed with dyslexia. Diagnosed with multiple sclerosis. Diagnosed with a seizure disorder/epilepsy. History of a traumatic brain injury. Currently pregnant. Unable to read and understand English. Difficulty seeing and hearing instructions on a computer. Endorsement of current substance abuse problem. Having a history of electro-shock therapy. Reporting having a medication change in the previous 3-months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bridget R. Kennedy
Phone
19035120486
Email
bridgetkennedy@uttyler.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Sass
Phone
9035667239
Email
ssass@uttyler.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget R. Kennedy
Organizational Affiliation
UT Tyler
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75799
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bridget R Kennedy
Phone
903-512-0486
Email
bridgetkennedy@uttyler.edu
First Name & Middle Initial & Last Name & Degree
Sarah M Sass, PhD
Phone
903-566-7239
Email
ssass@uttyler.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan at this time to share any data with other researchers. In the event that any data were to be shared, it would only be de-identified and we would follow appropriate guidelines as outlined by UT Tyler's IRB.
Citations:
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Optimizing Attentional Bias Modification

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