Clinical trial NCT05816564: Optimizing Attentional Bias Modification
Official title: Optimizing Attentional Bias Modification for Depression: Does Mindfulness Help?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Attention Bias
Mindfulness
Lead sponsor: University of Texas at Tyler
Sponsor class: OTHER
Collaborators: name: Psi Chi
name: Sarah Sass, PhD
First posted: 2023-04-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to positive attention training or "sham" attention training but will both receive mindfulness exercises.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Amplitude changes (in microvolts) for scalp-recorded event-related potential (ERP) data.
timeFrame: Changes in ERP amplitudes from the baseline attention task to the final attention task on day 3 of the study.
measure: Reaction Time (RT)
timeFrame: Changes in RT from the baseline attention task to the final attention task on day 3 of the study.
measure: Patient Health Questionnaire- 9-item
timeFrame: Change from baseline depression symptoms (day 1 of study) to immediately after the 3-day intervention.
measure: Patient Health Questionnaire- 9-item
timeFrame: Change from baseline depression symptoms (day 1 of study) to 4-weeks post-intervention.
measure: Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
timeFrame: Change from baseline anhedonic depression symptoms (day 1 of study) to immediately after the 3-day intervention.
measure: Mood and Anxiety Symptom Questionnaire-Anhedonic Depression Subscale
timeFrame: Change from baseline anhedonic depression symptoms (day 1 of study) to 4-weeks post-intervention.
measure: Ruminative Responses Scale-8 item
timeFrame: Change from baseline rumination levels (day 1 of study) to immediately after the 3-day intervention.
measure: Ruminative Responses Scale-8 item
timeFrame: Change from baseline rumination levels (day 1 of study) to 4-weeks post-intervention.
Secondary outcomes:
measure: Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
timeFrame: Change from baseline anxious arousal symptoms (day 1 of study) to immediately after the 3-day intervention.
measure: Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
timeFrame: Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.
measure: Penn State Worry Questionnaire
timeFrame: Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.
measure: Penn State Worry Questionnaire
timeFrame: Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.
measure: Cognitive and Affective Mindfulness Scale- Revised
timeFrame: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
measure: Cognitive and Affective Mindfulness Scale- Revised
timeFrame: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
measure: Five Facet Mindfulness Questionnaire
timeFrame: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
measure: Five Facet Mindfulness Questionnaire
timeFrame: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas at Tyler
state: Texas
Study officials:
affiliation: UT Tyler
name: Bridget R. Kennedy
role: PRINCIPAL_INVESTIGATOR
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