Optimizing Attentional Bias Modification

Depression Clinical Trial

Official title:

Optimizing Attentional Bias Modification for Depression: Does Mindfulness Help?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05816564
• Other study ID #: IRB-FY2021-51
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Texas at Tyler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Attention Bias Modification (ABM) for depression
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.
• Sham Attention Bias Modification (ABM)
The sham intervention will be given to the control group (but they will still receive mindfulness exercises).

Locations

Country	Name	City	State
United States	The University of Texas at Tyler	Tyler	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas at Tyler	Psi Chi, Sarah Sass, PhD

Country where clinical trial is conducted

United States, 

References & Publications (14)

Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman Self-Rating Mania Scale. Biol Psychiatry. 1997 Nov 15;42(10):948-55. doi: 10.1016/S0006-3223(96)00548-3. — View Citation

Beevers CG, Clasen PC, Enock PM, Schnyer DM. Attention bias modification for major depressive disorder: Effects on attention bias, resting state connectivity, and symptom change. J Abnorm Psychol. 2015 Aug;124(3):463-75. doi: 10.1037/abn0000049. — View Citation

Bo R, Kraft B, Jonassen R, Harmer CJ, Hilland E, Stiles TC, Haaland VO, Aspesletten MEB, Sletvold H, Landro NI. Symptom severity moderates the outcome of attention bias modification for depression: An exploratory study. J Psychiatr Res. 2021 Jun;138:528-534. doi: 10.1016/j.jpsychires.2021.04.027. Epub 2021 May 5. — View Citation

Bredemeier K, Spielberg JM, Silton RL, Berenbaum H, Heller W, Miller GA. Screening for depressive disorders using the Mood and Anxiety Symptoms Questionnaire Anhedonic Depression Scale: a receiver-operating characteristic analysis. Psychol Assess. 2010 Sep;22(3):702-10. doi: 10.1037/a0019915. — View Citation

Conley MI, Dellarco DV, Rubien-Thomas E, Cohen AO, Cervera A, Tottenham N, Casey BJ. The racially diverse affective expression (RADIATE) face stimulus set. Psychiatry Res. 2018 Dec;270:1059-1067. doi: 10.1016/j.psychres.2018.04.066. Epub 2018 May 19. — View Citation

Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28. — View Citation

Farb NA, Anderson AK, Segal ZV. The mindful brain and emotion regulation in mood disorders. Can J Psychiatry. 2012 Feb;57(2):70-7. doi: 10.1177/070674371205700203. — View Citation

Fodor LA, Georgescu R, Cuijpers P, Szamoskozi S, David D, Furukawa TA, Cristea IA. Efficacy of cognitive bias modification interventions in anxiety and depressive disorders: a systematic review and network meta-analysis. Lancet Psychiatry. 2020 Jun;7(6):506-514. doi: 10.1016/S2215-0366(20)30130-9. Epub 2020 May 20. — View Citation

Jones EB, Sharpe L. Cognitive bias modification: A review of meta-analyses. J Affect Disord. 2017 Dec 1;223:175-183. doi: 10.1016/j.jad.2017.07.034. Epub 2017 Jul 18. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Mennen AC, Norman KA, Turk-Browne NB. Attentional bias in depression: understanding mechanisms to improve training and treatment. Curr Opin Psychol. 2019 Oct;29:266-273. doi: 10.1016/j.copsyc.2019.07.036. Epub 2019 Jul 31. — View Citation

Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324. — View Citation

Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2013). Mindfulness-based Cognitive Therapy for Depression, 2nd ed. New York, NY: The Guilford Press.

Watson D, Clark LA, Weber K, Assenheimer JS, Strauss ME, McCormick RA. Testing a tripartite model: II. Exploring the symptom structure of anxiety and depression in student, adult, and patient samples. J Abnorm Psychol. 1995 Feb;104(1):15-25. doi: 10.1037//0021-843x.104.1.15. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes in ERP amplitudes from the baseline attention task to the final attention task on day 3 of the study.
Primary	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.	Changes in RT from the baseline attention task to the final attention task on day 3 of the study.
Primary	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.	Change from baseline depression symptoms (day 1 of study) to immediately after the 3-day intervention.
Primary	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.	Change from baseline depression symptoms (day 1 of study) to 4-weeks post-intervention.
Primary	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.	Change from baseline anhedonic depression symptoms (day 1 of study) to immediately after the 3-day intervention.
Primary	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.	Change from baseline anhedonic depression symptoms (day 1 of study) to 4-weeks post-intervention.
Primary	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.	Change from baseline rumination levels (day 1 of study) to immediately after the 3-day intervention.
Primary	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.	Change from baseline rumination levels (day 1 of study) to 4-weeks post-intervention.
Secondary	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.	Change from baseline anxious arousal symptoms (day 1 of study) to immediately after the 3-day intervention.
Secondary	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.	Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.
Secondary	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.	Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.
Secondary	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.	Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.
Secondary	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.	Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Secondary	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.	Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Secondary	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.	Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Secondary	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.	Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.