DepressionNCT05816564
Optimizing Attentional Bias Modification
A study testing Attention Bias Modification (ABM) for depression in people with Depression, run by University of Texas at Tyler at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Attention Bias Modification (ABM) for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Report of mild-to-moderate levels of depression symptoms.
- Must be able to read and understand English.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Tyler
Tyler, Texas, 75799
About this study
Official title: Optimizing Attentional Bias Modification for Depression: Does Mindfulness Help?
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Attention Bias Modification (ABM) for depression, Sham Attention Bias Modification (ABM)
- Keywords
- Attention Bias, Mindfulness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias Modification (ABM) for depressionBehavioural
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)Behavioural
The sham intervention will be given to the control group (but they will still receive mindfulness exercises).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Attention Bias Modification (ABM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.
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.
Measured: Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.
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.
Measured: Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.
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.
Measured: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
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.
Measured: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
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.
Measured: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
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.
Measured: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Oct 2022
- Primary completion1 May 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to positive attention training or "sham" attention training but will both receive mindfulness exercises.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Psi Chi, Sarah Sass, PhD
- Responsible party
- Principal investigator, Bridget Kennedy, University of Texas at Tyler
- Investigators
- Bridget R. Kennedy, Principal investigator, UT Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816564
- Sponsor's protocol ID
- IRB-FY2021-51
- Status last verified
- May 2024
- First submitted
- 3 Feb 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25894440Bredemeier 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.
PubMed 20822283Bo 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.
PubMed 33984807Conley 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.
PubMed 29910020Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
PubMed 27687118Farb 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.
PubMed 22340146Fodor 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.
PubMed 32445689Jones 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.
PubMed 28759865Kroenke 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.
PubMed 11556941Mennen 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.
PubMed 31521030Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2013). Mindfulness-based Cognitive Therapy for Depression, 2nd ed. New York, NY: The Guilford Press.
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.
PubMed 29939051Watson 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.
PubMed 7897037Altman 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.
PubMed 9359982
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Attentional Bias Modification for Depression: Does Mindfulness Help?
- ClinicalTrials.gov ID
- NCT05816564
- Acronym / sponsor ID
- IRB-FY2021-51
- Conditions
- Depression
- Keywords
- Attention Bias, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Texas at TylerUniversity, hospital or other
- Collaborators
- Psi Chi, Sarah Sass, PhD
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to positive attention training or "sham" attention training but will both receive mindfulness exercises.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Attention Bias Modification (ABM) for depressionThis 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. |
| Placebo/Control Group | Placebo comparator | Behavioral: Sham Attention Bias Modification (ABM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Report of mild-to-moderate levels of depression symptoms.
- Must be able to read and understand English.
Key exclusion criteria (12 listed)
- Under the age of 18 years old.
- Diagnosed with ADHD.
- Diagnosed with dyslexia.
- Diagnosed with multiple sclerosis.
- Diagnosed with a seizure disorder/epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Bias Modification (ABM) for depressionBoth 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. | Behavioural | Experimental Group |
| Sham Attention Bias Modification (ABM)The sham intervention will be given to the control group (but they will still receive mindfulness exercises). | Behavioural | Placebo/Control Group |
Primary outcome
Amplitude changes (in microvolts) for scalp-recorded event-related potential (ERP) data.
Time frame: Changes in ERP amplitudes from the baseline attention task to the final attention task on day 3 of the study.
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)
Time frame: Changes in RT from the baseline attention task to the final attention task on day 3 of the study.
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
Time frame: Change from baseline depression symptoms (day 1 of study) to immediately after the 3-day intervention.
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
Time frame: Change from baseline depression symptoms (day 1 of study) to 4-weeks post-intervention.
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
Time frame: Change from baseline anhedonic depression symptoms (day 1 of study) to immediately after the 3-day intervention.
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
Time frame: Change from baseline anhedonic depression symptoms (day 1 of study) to 4-weeks post-intervention.
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
Time frame: Change from baseline rumination levels (day 1 of study) to immediately after the 3-day intervention.
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
Time frame: Change from baseline rumination levels (day 1 of study) to 4-weeks post-intervention.
Ruminative Responses Scale-8 item is commonly used to measure people's general tendency to ruminate. Higher scores suggest higher levels of rumination.
8 secondary outcomes
Mood and Anxiety Symptom Questionnaire-Anxious Arousal Subscale
Time frame: 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
Time frame: Change from baseline anxious arousal symptoms (day 1 of study) to 4-weeks post-intervention.
Penn State Worry Questionnaire
Time frame: Change from baseline anxious apprehension symptoms (day 1 of study) to immediately after the 3-day intervention.
Penn State Worry Questionnaire
Time frame: Change from baseline anxious apprehension symptoms (day 1 of study) to 4-weeks post-intervention.
Cognitive and Affective Mindfulness Scale- Revised
Time frame: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Cognitive and Affective Mindfulness Scale- Revised
Time frame: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Five Facet Mindfulness Questionnaire
Time frame: Change from baseline mindfulness levels (day 1 of study) to immediately after the 3-day intervention.
Five Facet Mindfulness Questionnaire
Time frame: Change from baseline mindfulness levels (day 1 of study) to 4-weeks post-intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 25894440Beevers 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.
- Background: PubMed 20822283Bredemeier 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.
- Background: PubMed 33984807Bo 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.
- Background: PubMed 29910020Conley 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.
- Background: PubMed 27687118Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
- Background: PubMed 22340146Farb 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.
- Background: PubMed 32445689Fodor 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.
- Background: PubMed 28759865Jones 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 31521030Mennen 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.
- BackgroundSegal, 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: PubMed 29939051Schumer 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget R. Kennedy principal investigator
UT Tyler
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification (ABM) for depression in people with Depression, run by University of Texas at Tyler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude changes (in microvolts) for scalp-recorded event-related potential (ERP) data. (time frame: Changes in ERP amplitudes from the baseline attention task to the final attention task on day 3 of the study.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816564, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.