Optimizing Attentional Bias Modification

NCT05816564 | Active Not Recruiting

• 1 other identifier: IRB-FY2021-51
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Attention Bias; Mindfulness

Outcome Measures

Primary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (8)

• Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale

  Change from baseline anxious arousal symptoms (day 1 of study) to immediately after the 3-day intervention.

• Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale

  Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.

• Penn State Worry Questionnaire

  Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.

• Penn State Worry Questionnaire

  Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.

• Cognitive and Affective Mindfulness Scale- Revised

  Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Attention Bias Modification (ABM) for depression

Placebo/Control Group

PLACEBO COMPARATOR

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.

Behavioral: Sham Attention Bias Modification (ABM)

Interventions

Attention Bias Modification (ABM) for depression BEHAVIORAL

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.

Experimental Group

Sham Attention Bias Modification (ABM) BEHAVIORAL

The sham intervention will be given to the control group (but they will still receive mindfulness exercises).

Placebo/Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Report of mild-to-moderate levels of depression symptoms.
• Must be able to read and understand English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Tyler: lead
• Psi Chi: collaborator
• Sarah Sass, PhD: collaborator

Study Sites (1)

The University of Texas at Tyler

Tyler, Texas, 75799, United States

Location

Related Publications (14)

• 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.

  PMID: 25894440 BACKGROUND

• 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.

  PMID: 20822283 BACKGROUND

• 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.

  PMID: 33984807 BACKGROUND

• 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.

  PMID: 29910020 BACKGROUND

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

  PMID: 27687118 BACKGROUND

• 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.

  PMID: 22340146 BACKGROUND

• 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.

  PMID: 32445689 BACKGROUND

• 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.

  PMID: 28759865 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 31521030 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29939051 BACKGROUND

• 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.

  PMID: 7897037 BACKGROUND

• 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.

  PMID: 9359982 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Bridget R. Kennedy

  UT Tyler

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be debriefed after study but are not specifically told that they were recruited due to reported depression symptoms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Research Assistant

Model Details: Participants will be randomly assigned to positive attention training or "sham" attention training but will both receive mindfulness exercises.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: April 18, 2023
• Study Start: October 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)