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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA026844 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Alcohol use disorder (AUD) accompanied by early trauma presents clinical challenges, including elevated rates of comorbid emotional symptoms and relapse. To better understand this co-occurring condition, this study investigates the neurobiological responses associated with AUD and early trauma. Using a multimodal neuroimaging approach, including functional magnetic resonance imaging (fMRI), the study concurrently measures brain activity and stress hormone responses in individuals with AUD and control participants, both with and without early trauma. The primary goal is to examine neurobiological responses and relapse patterns following treatment in individuals with AUD, with and without a history of early trauma. Conventional alcohol treatments often fail to specifically address the emotional complications in AUD individuals with early trauma. Therefore, this study also explores whether incorporating stress regulation into alcohol relapse prevention can improve outcomes for this population. Following baseline assessments that included multimodal neuroimaging, all participants with AUD received an 8-week outpatient treatment program integrating cognitive-behavioral methods focused on emotion regulation with stress reduction techniques, particularly self-regulated breathing strategies.
The study recruited four demographically matched groups (age, sex ratio): individuals with AUD with and without a history of early trauma, and moderate drinkers with and without early trauma. Study procedures involved functional magnetic resonance imaging (fMRI), an eight-week outpatient treatment program, and a 90-day follow-up period. During fMRI sessions, participants engaged in a validated emotion provocation task, viewing stress, alcohol-cue, and neutral images while concurrent brain and stress hormone data are collected. Individuals with AUD completed baseline assessments, including multimodal neuroimaging, and then participated in an 8-week treatment program consisting of two sessions per week. This program integrated cognitive-behavioral techniques focused on emotion regulation with breathing-based stress management. Control participants completed baseline assessments including multimodal neuroimaging but did not receive any treatment. Following the treatment, participants with AUD were prospectively followed for 90 days, with remote follow-up interviews conducted at 14, 30, 90 days via video communication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol use disorder with early trauma | Other | Individuals with alcohol use disorder participated in an equivalent 8-week outpatient treatment program. |
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| Alcohol use disorder without early trauma | Other | Individuals with alcohol use disorder participated in an equivalent 8-week outpatient treatment program. |
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| Controls with early trauma | No Intervention | Control participants did not receive any treatment. | |
| Controls without early trauma | No Intervention | Control participants did not receive any treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8-week outpatient treatment | Behavioral | Individuals with AUD participated in an 8-week treatment program integrating cognitive behavioral techniques focused on emotion regulation with breathing-based stress management. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Response | Brain responses during the viewing of stress, alcohol-cue, and neutral images were examined using functional magnetic resonance imaging (fMRI) during an emotion provocation task. A regions of interest (ROI) analysis was conducted to assess brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas, and beta values were obtained using the BioImage Suite. The beta coefficient represents the extent to which a specific condition contributes to changes in the BOLD (Blood Oxygen Level Dependent) signal in a particular brain region. A positive beta in the vmPFC would indicate an increased vmPFC response, whereas a negative beta would indicate a decreased vmPFC response compared to baseline. The magnitude of the beta reflects the strength of this effect: a larger absolute value, (whether positive or negative), suggests a greater change in brain activation in response to the condition. | baseline |
| Stress Hormone Response (Cortisol to ACTH Ratio) | Cortisol to Adrenocorticotropic Hormone (ACTH) ratio indicates the relationship between cortisol secretion and ACTH stimulation at baseline. Cortisol is measured in micrograms per deciliter (µg/dL) and ACTH (adrenocorticotropic hormone) is measured in picograms per milliliter (pg/mL). Therefore, the unit of cortisol to ACTH ratio is expressed in µg/dL per pg/mL. Stress hormone samples were collected during the MRI scan. | baseline |
| Time to Relapse | The first day of alcohol consumption after treatment during the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Alcohol Consumption (Weekly) | Average weekly alcohol consumption over the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. |
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AUD inclusion Criteria:
AUD exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongju Seo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06492 | United States |
Out of the 148 enrolled participants, 17 individuals did not start the study due to participant withdrawal (N=14), MRI-day ineligibility (N=2), and non-compliance (N=1).
All participants were recruited starting on October 3, 2019 through online platforms and flyers. A recruitment center was located in New Haven, Connecticut.
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| ID | Title | Description |
|---|---|---|
| FG000 | AUD/ET | Individuals with alcohol use disorder and early trauma: Individuals with alcohol use disorder will receive an 8-week outpatient treatment, involving two sessions per week that integrate cognitive behavioral therapy with breathing-based stress management. |
| FG001 | AUD/NT | Individuals with alcohol use disorder without early trauma: Individuals with alcohol use disorder will receive an 8-week outpatient treatment, involving two sessions per week that integrate cognitive behavioral therapy with breathing-based stress management. |
| FG002 | MD/ET | Moderate social drinkers (controls) with a history of early trauma: Control participants will undergo a baseline assessment without receiving any outpatient treatment. |
| FG003 | MD/NT | Moderate social drinkers (controls) without a history of early trauma: Control participants will undergo a baseline assessment without receiving any outpatient treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Out of the 148 enrolled participants, 17 participants did not start the study due to participant withdrawal (N=14), MRI-day ineligibility (N=2), and non-compliance (N=1).
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| ID | Title | Description |
|---|---|---|
| BG000 | AUD/ET | Individuals with alcohol use disorder (AUD) and early trauma (ET): Individuals with alcohol use disorder completed baseline assessments and then received an 8-week outpatient treatment that integrates alcohol treatment based on cognitive behavioral methods with breathing-based stress management. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Response | Brain responses during the viewing of stress, alcohol-cue, and neutral images were examined using functional magnetic resonance imaging (fMRI) during an emotion provocation task. A regions of interest (ROI) analysis was conducted to assess brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas, and beta values were obtained using the BioImage Suite. The beta coefficient represents the extent to which a specific condition contributes to changes in the BOLD (Blood Oxygen Level Dependent) signal in a particular brain region. A positive beta in the vmPFC would indicate an increased vmPFC response, whereas a negative beta would indicate a decreased vmPFC response compared to baseline. The magnitude of the beta reflects the strength of this effect: a larger absolute value, (whether positive or negative), suggests a greater change in brain activation in response to the condition. | In AUD/ET, one participant did not complete the fMRI part of the study, resulting in N=33 for brain response. Among them, one participant only completed alcohol cue condition due to discomfort with the MRI scan. In AUD/NT, two participants did not complete the fMRI part of the study, resulting in N=31. In MD/ET, one participant did not complete the stress condition. In MD/NET, one participant did not complete the alcohol condition, and two participants did not complete the stress condition. | Posted | Mean | Standard Deviation | unitless | baseline |
5.5 months for individuals with alcohol use disorder; 1.5 months for individuals without alcohol use disorder
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AUD/ET | Individuals with alcohol use disorder and early trauma: Individuals with alcohol use disorder completed baseline assessments including multimodal neuroimaging. Then, they participated in an 8-week outpatient treatment program integrating cognitive-behavioral techniques focused on emotion regulation with breathing-based stress management. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | One participant reported a single episode of low back pain in week 4, while another participant reported two episodes in weeks 3 and 5. All episodes were attributed to a pre-existing condition and were unrelated to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dongju Seo | Department of Psychiatry, Yale University School of Medicine | 475-441-3457 | dongju.seo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 28, 2022 | Sep 4, 2024 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000553 | Ambulatory Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Following baseline assessments including multimodal neuroimaging, AUD individuals with and without a history of early trauma received an equivalent 8-week outpatient treatment. Control participants with and without early trauma did not receive any treatment after baseline assessments.
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| up to 90 days |
| Frequency of Alcohol Use (Percentage) | Percentage of alcohol use days over the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. | up to 90 days |
| noncompliance |
|
| AUD/NT |
Individuals with alcohol use disorder without early trauma: Individuals with alcohol use disorder completed baseline assessments and then received an 8-week outpatient treatment that integrates alcohol treatment based on cognitive behavioral methods with breathing-based stress management. |
| BG002 | MD/ET | Moderate drinkers (controls) with early trauma: Control participants completed baseline assessments without receiving any outpatient treatment. |
| BG003 | MD/NT | Moderate drinkers (controls) without early trauma: Control participants completed baseline assessments without receiving any outpatient treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Early Trauma Score | The Childhood Trauma Questionnaire (CTQ) is a 28-item self-report questionnaire designed to assess childhood trauma and maltreatment, consisting of five subscales: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each subscale is scored separately, and the sum of these scores provides a CTQ total score ranging from 25 to 125. Higher total scores indicate greater levels of self-reported childhood trauma exposure. The total CTQ scores are presented in this table. | Mean | Standard Deviation | units on a scale |
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| Amount of alcohol consumption (weekly) | The amount of weekly alcohol consumption was assessed using the Timeline Follow-Back (TLFB) method, a calendar-based self-report measure commonly used to track daily alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. | Mean | Standard Deviation | alcohol drinks (weekly) |
|
| Days of alcohol consumption (weekly) | The number of days of weekly alcohol consumption was assessed using the Timeline Follow-Back (TLFB) method, a calendar-based self-report measure commonly used to track daily alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. | Mean | Standard Deviation | days of alcohol use (weekly) |
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| Primary | Stress Hormone Response (Cortisol to ACTH Ratio) | Cortisol to Adrenocorticotropic Hormone (ACTH) ratio indicates the relationship between cortisol secretion and ACTH stimulation at baseline. Cortisol is measured in micrograms per deciliter (µg/dL) and ACTH (adrenocorticotropic hormone) is measured in picograms per milliliter (pg/mL). Therefore, the unit of cortisol to ACTH ratio is expressed in µg/dL per pg/mL. Stress hormone samples were collected during the MRI scan. | Among the 33 AUD/ET participants who underwent MRI scans, 3 blood samples were not collected due to nurse unavailability (N=2) and difficult venous access (N=1). In the 31 AUD/NT MRI participants, two samples were not collected due to technical issues. Of the 27 MD/ET, 5 samples were not collected due to nurse unavailability (N=5) and a technical issue (N=1). Of the 37 MD/NT, 6 samples were not collected due to nurse unavailability (N=4), IV tubing issue (N=1), and participant refusal (N=1). | Posted | Mean | Standard Deviation | µg/dL per pg/ml | baseline |
|
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|
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| Primary | Time to Relapse | The first day of alcohol consumption after treatment during the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. | Among the 34 AUD/ET participants, one dropped out before starting treatment, leaving 33 to begin the 8-week intervention. Of these, 29 completed the treatment and follow-up. Among the 33 AUD/NT participants, two dropped out before the treatment, leaving 31 who initiated the treatment. Of these, 28 completed the treatment and two lost to follow-up for this measure. The MD/ET and MD/NT groups did not start treatment therefore no data was collected for the MD groups. | Posted | Mean | Standard Deviation | days to first drink after treatment | up to 90 days |
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| Secondary | Amount of Alcohol Consumption (Weekly) | Average weekly alcohol consumption over the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. | Among the 34 AUD/ET participants, one dropped out before treatment, leaving 33 to start the intervention, with 29 completing treatment and follow-up (FU). Among the 33 AUD/NT participants, two dropped out before treatment, leaving 31 to initiate the intervention, with 28 completing treatment and three lost to follow-up for this measure (two before the 14-day FU, one before the 90-day FU). The MD/ET and MD/NT groups did not start treatment therefore no data was collected for the MD groups. | Posted | Mean | Standard Deviation | alcohol drinks (weekly) | up to 90 days |
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| Secondary | Frequency of Alcohol Use (Percentage) | Percentage of alcohol use days over the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment. | Among the 34 AUD/ET participants, one dropped out before treatment, leaving 33 to start the 8-week intervention, with 29 completing treatment and follow-up (FU). Among the 33 AUD/NT participants, two dropped out before treatment, leaving 31 to initiate the intervention, with 28 completing treatment and three lost to follow-up (two before the 14-day FU, one before the 90-day FU). The MD/ET and MD/NT groups did not start treatment therefore no data was collected for the MD groups. | Posted | Mean | Standard Deviation | Percentage of alcohol use days | up to 90 days |
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|
| 0 |
| 34 |
| 0 |
| 34 |
| 4 |
| 34 |
| EG001 | AUD/NT | Individuals with alcohol use disorder without early trauma: Individuals with alcohol use disorder completed baseline assessments including multimodal neuroimaging. Then, they participated in an 8-week outpatient treatment program integrating cognitive-behavioral techniques focused on emotion regulation with breathing-based stress management. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | MD/ET | Moderate drinkers (controls) with early trauma: Control participants completed baseline assessments including multimodal neuroimaging but did not receive any treatment. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | MD/NT | Moderate drinkers (controls) without early trauma: Control participants completed baseline assessments including multimodal neuroimaging but did not receive any treatment. | 0 | 37 | 0 | 37 | 0 | 37 |
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| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One participant contracted COVID-19 in week 9 after treatment, while another participant was infected during week 5 of the treatment. Both cases were regarded as unrelated to study participation. |
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