An interventional study of real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS in Major Depressive Disorder, sponsored by Kymberly Young. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Kymberly Young · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the clinical efficacy of augmenting cognitive-behavioral therapy with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories.
Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's response to positive autobiographical memory recall holds therapeutic potential for treating patients with major depressive disorder (MDD), as clinically significant decreases in clinician administered and self-report measures of depression severity were observed following two rtfMRI amygdala neurofeedback sessions. Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive bias. As this rtfMRI-nf procedure utilizes principles of cognitive-behavioral therapy (CBT), including restructuring thoughts and emotional processing towards the positive, the current study seeks to examine the effects of augmenting CBT with amygdala rtfMRI-nf. Specifically, the investigators plan to test the hypothesis that pretreatment with two amygdala rtfMRI-nf sessions prior to the the start of CBT will result in a higher percentage of patients who exhibit 'sudden gains' (a between session drop of at least 25% on the Beck Depression Inventory associated with better treatment response) compared to those who receive rtfMRI-nf from a parietal control region putatively not involved in emotional processing. Over the course of three years, 60 participants diagnosed with MDD and planning to start CBT will be recruited through the clinical services of the Western Psychiatric Institute and Clinic (WPIC) and through licensed CBT therapists in the Pittsburgh metropolitan area. Participants will undergo two rtfMRI-nf sessions within the two weeks prior to starting therapy. Half of the participants will receive amygdala neurofeedback and half will receive control neurofeedback. At weeks 1-3 and 9 \& 10 following the start of therapy, the participant will complete the BDI-II and the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression measure. The number of patients who meet criteria for sudden gains and the average session at which this occurred will be compared between CBT + amygdala rtfMRI-nf and CBT + control rtfMRI-nf groups. Success will suggest a new method for improving outcomes to CBT in depressed patients.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Kymberly Young is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
Device: real-time fMRI neurofeedback: Amygdala
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
Device: real-time fMRI neurofeedback: HIPS
Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
Time frame: 10 weeks
PROMIS Item Bank v1.0 - Depression
The PROMIS depression measure is a self-report measure of depressive symptoms consisting of 8 questions. Scores can range from 0-40 with higher scores indicating greater severity of depression. The raw scores are converted to T scores with scores with a mean of 50 and a standard deviation of 10. Scores under 55 indicate no depression and scores above 70 indicate severe depression.
Time frame: 10 weeks
| Milestone | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS |
|---|---|---|
| Started | 19 | 17 |
| Completed | 18 | 17 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
| units on a scale | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS |
|---|---|---|
| Beck Depression Inventory (BDI-II) | 16.1 ± 9.66 | 24.3 ± 12.3 |
The PROMIS depression measure is a self-report measure of depressive symptoms consisting of 8 questions. Scores can range from 0-40 with higher scores indicating greater severity of depression. The raw scores are converted to T scores with scores with a mean of 50 and a standard deviation of 10. Scores under 55 indicate no depression and scores above 70 indicate severe depression.
| t-score | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS |
|---|---|---|
| PROMIS Item Bank v1.0 - Depression | 53 ± 11 | 61 ± 12 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real-time fMRI Neurofeedback: Amygdala | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Real-time fMRI Neurofeedback: HIPS | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| Mean | 32 ± 12 | 31 ± 9 | 32 ± 10 |
| Sex: Female, Male(Participants) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 6 | 4 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 18 | 17 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 18 | 15 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| United States | 19 | 17 | 36 |
| Beck Depression Inventory Baseline(units on a scale) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| Mean | 27.2 ± 10.7 | 26.6 ± 13.4 | 26.8 ± 11.8 |
| PROMIS Baseline(t-score) | Real-time fMRI Neurofeedback: Amygdala | Real-time fMRI Neurofeedback: HIPS | Total |
|---|---|---|---|
| Mean | 68 ± 8 | 66 ± 9 | 67 ± 9 |
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Kymberly Young