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| ID | Type | Description | Link |
|---|---|---|---|
| HX-002796 | Other Grant/Funding Number | VA Health Services Research | |
| CIRB 20-22 | Other Identifier | VA Central Institutional Review Board |
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This 4-year study will examine the value of a type of a brief cognitive behavioral therapy treatment for Veterans with anxiety and worry. This treatment will be delivered either in-person, or by video telehealth to the Veteran's home. The treatment will be delivered by providers at three Veterans Administration Medical Centers (Houston, New Orleans, and San Antonio). The study will compare the helpfulness of this treatment to the usual care Veterans receive for anxiety and worry. A supplement to this study will also evaluate daily discrimination experiences of Veterans based on the participant's race, ethnicity, religion, physical appearance, or other characteristics.
This multisite trial (Houston, New Orleans and San Antonio) will use a pragmatic randomized trial design to examine the effectiveness and implementation potential of a brief cognitive behavioral therapy(bCBT) intervention for anxiety delivered either in-person or via VA Video Connect-Home (VVC-H), according to patient preference. Brief CBT will be delivered by existing Primary Care Mental Health Integration (PCMHI) providers at three large VAMCs (Houston, New Orleans, and San Antonio). Aim 1 will examine the clinical effectiveness of the bCBT intervention vs. Enhanced Usual Care (EUC) for anxiety at 4-, 8-, and 12-month follow-ups. Aim 2 will determine factors associated with bCBT response and explore Veteran demographic and clinical factors associated with VVC-H engagement. An exploratory aim will use mixed, qualitative and quantitative methods to better understand implementation successes and challenges related to delivery and impact of bCBT anxiety and VVC-H use in the PCMHI setting. The primary hypothesis is that anxiety outcomes, as measured by the General Anxiety Disorder 7-item scale (GAD-7) will be superior at 4-, 8-, and 12-month follow up for patients who are assigned to receive bCBT vs. EUC.
In addition, participants will be asked to complete the Diversity Supplement measures and qualitative interview to evaluate whether sociocultural factors are associated with the severity and type of anxiety symptoms among Veterans of different race/ethnicity groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Cognitive Behavioral Therapy | Experimental | The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills. |
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| Enhanced Usual Care | No Intervention | EUC participants will receive anxiety education materials, a note in their medical record indicating the presence of elevated anxiety symptoms, and 4 brief monthly check-in calls with project staff. The primary outcome, anxiety symptoms, will be evaluated at 4-, 8- and 12-month follow-ups. Due to ethical concerns of withholding needed treatment, EUC participants will NOT be restricted from receiving mental health services including psychotherapy during the study period. The investigators fully expect that EUC participants may receive anxiety treatments (e.g., antianxiety and antidepressant medications or psychotherapy). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Behavioral Therapy | Behavioral | The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills. |
| Measure | Description | Time Frame |
|---|---|---|
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. It is psychometrically strong and valid for use in the primary care setting. A GAD-7 score of 10 or higher will be required for study inclusion. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. | Baseline, 4-, 8-, and 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale (OASIS) | The OASIS will be a secondary measure of anxiety. Unlike the GAD-7, which will be administered by both research staff and PCMHI providers, the OASIS will only be administered by research staff, thereby avoiding response bias that may occur in the clinical setting. The OASIS is a widely used five-item measure of anxiety for primary care settings assessing anxiety frequency, anxiety severity, avoidance behaviors, social interference, and interference at work, school, or home. Each item of the OASIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. A higher score indicates a poorer outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terri L. Fletcher, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Louisiana Veterans Health Care System, New Orleans, LA | New Orleans | Louisiana | 70119 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37261762 | Background | Cully JA, Fischer EP, Gonzalez R, Williams JS, Sansgiry S, Zeno D, Mittal D, Kuo I. Provider perceptions and use of mental health services in the Veterans Health Administration during the COVID-19 pandemic. Psychol Serv. 2024 Feb;21(1):110-119. doi: 10.1037/ser0000772. Epub 2023 Jun 1. | |
| Background | Ecker AH, Cully JA, Cucciare MA, Hundt NE. Patient and Provider Perspectives on Treating Substance Use Disorder and Co-Occurring Anxiety and Posttraumatic Stress Disorders in the Veterans Affairs Healthcare System. Journal of Veterans Studies. 2023 Jun 1; 9(1):171-180. | ||
| 37674395 |
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Eligibility determination occurred after informed consent. Of the 347 Veterans who signed consent forms, many were deemed ineligible at baseline due to various reasons: 1) being unreachable or declining assessment, 2) not meeting the required GAD-7 scores, 3) having an excluded mental health diagnosis, 4) receiving mental health treatment, or 5) relocating outside the catchment area. Ultimately, 225 eligible participants were randomized to treatment (60%) or Enhanced Usual Care (EUC) (40%).
Veterans enrolled in Houston, New Orleans, and San Antonio VA Medical Centers were recruited if they: 1) were diagnosed with anxiety disorders and 2) had significant anxiety symptoms (GAD-7 score≥10). Exclusion criteria: 1) cognitive impairment, 2) bipolar or psychotic disorders, 3) substance use disorders, and 4) current psychotherapy for anxiety. Recruitment involved opt-out letters, phone calls, and direct provider referral. Interested Veterans underwent 2 screenings for anxiety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Participants in the bCBT-A arm were offered 4-9 sessions of measurement-based care, depending on their treatment response by the fourth session. Veterans could receive bCBT-A in person or via VA Video Connect to Home. All participants took part in an initial session where they received psychoeducation on anxiety and the bCBT treatment approach, set goals, and began self-monitoring. Three core skill sessions focused on relaxation, cognitive skills, and exposure techniques followed. All participants received a final wrap-up session to review gains and plan for skill maintenance. |
| FG001 | Enhanced Usual Care (EUC) | Participants in the EUC group received educational materials on managing anxiety, made available both by mail and through a weblink. They also received a letter encouraging them to discuss treatment options with their VA care providers. Additionally, a note was placed in the participant's electronic medical record to inform their primary care provider (PCP) and most recent Primary Care Mental Health Integration (PCMHI) provider of the presence of anxiety symptoms. Furthermore, EUC participants received four brief monthly check-in calls from study staff to review the resource list and assess current anxiety symptoms, with their providers being alerted in the event of significant anxiety symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 4 Month |
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| 8 Month |
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| 12 Month |
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Following an initial screening, participants who consented were randomized only after a second confirmation of anxiety symptoms. A comprehensive baseline assessment and a chart review for psychotherapy treatment were conducted before making the final determination of study eligibility. Additional participants were consented to reach the final required sample size of 225.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Participants in the bCBT-A arm were offered 4-9 sessions of measurement-based care, depending on their treatment response by the fourth session. Veterans could receive bCBT-A in person or via VA Video Connect to Home. All participants took part in an initial session where they received psychoeducation on anxiety and the bCBT treatment approach, set goals, and began self-monitoring. Three core skill sessions focused on relaxation, cognitive skills, and exposure techniques followed. All participants received a final wrap-up session to review gains and plan for skill maintenance. |
| 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, Customized | 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 | General Anxiety Disorder-7 (GAD-7) | The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. It is psychometrically strong and valid for use in the primary care setting. A GAD-7 score of 10 or higher will be required for study inclusion. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. | The number of participants from previous assessments does not become the starting number for the next assessment. If a participant missed an assessment, they are only lost to follow up at that time point, but not future assessments time points. To increase power for the project's secondary outcomes and to reduce unnecessary recruitment, unequal allocation was used where approximately 60% of Veterans will be randomized to bBCT. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-, 8-, and 12-month |
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Adverse events were monitored for a 12-month period.
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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 | Brief Cognitive Behavioral Therapy for Anxiety (bCBT-A) | Participants in the bCBT-A arm were offered 4-9 sessions of measurement-based care, depending on their treatment response by the fourth session. Veterans could receive bCBT-A in person or via VA Video Connect to Home. All participants took part in an initial session where they received psychoeducation on anxiety and the bCBT treatment approach, set goals, and began self-monitoring. Three core skill sessions focused on relaxation, cognitive skills, and exposure techniques followed. All participants received a final wrap-up session to review gains and plan for skill maintenance. |
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This study was conducted during the COVID-19 pandemic, which may limit the interpretation and generalizability of findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terri L. Fletcher, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | 713-440-4490 | Terri.Fletcher@VA.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2023 | Mar 3, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2021 | Mar 3, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2023 | Apr 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D016584 | Panic Disorder |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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Cognitive behavioral therapy (CBT) is an evidence-based practice (EBP) for all types of anxiety disorders including generalized anxiety disorder (GAD), panic disorder, and social anxiety disorder. The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
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Outcome data will be collected by independent evaluators (IEs) who will be blinded to randomization. All IEs will be based in Houston, with direct oversight by Dr. Cully. IEs will undergo training and calibration on all study measures and be regularly reassessed for quality.
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| Baseline, 4-, 8-, and 12-month |
| Short Form-12 Physical Component Summary (SF-12-PCS) | The SF-12-PCS is a condensed, self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. | Baseline, 4-, 8-, and 12-month |
| Short Form-12 Mental Component Summary (SF12-MCS) | The SF12-MCS is a 12-question, patient reported survey evaluating emotional well-being. Mental Health Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators assessed quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. | Baseline, 4-, 8-, 12-month |
| Michael E. DeBakey VA Medical Center, Houston, TX |
| Houston |
| Texas |
| 77030-4211 |
| United States |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229 | United States |
| Background |
| Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7. |
| 37024645 | Background | Hertz AG, Dawson DB, Rassu FS, Ecker AH, Helm A, Hundt NE, Fletcher TL. Delivery of Exposure and Response Prevention Among Veterans with Obsessive-Compulsive Disorder. J Behav Health Serv Res. 2023 Oct;50(4):514-523. doi: 10.1007/s11414-023-09838-3. Epub 2023 Apr 6. |
| 36003211 | Background | Boykin DM, Wray LO, Funderburk JS, Holliday S, Kunik ME, Kauth MR, Fletcher TL, Mignogna J, Roberson RB 3rd, Cully JA. Leveraging the ExpandNet framework and operational partnerships to scale-up brief Cognitive Behavioral Therapy in VA primary care clinics. J Clin Transl Sci. 2022 Jul 20;6(1):e95. doi: 10.1017/cts.2022.430. eCollection 2022. |
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| BG001 | Enhanced Usual Care (EUC) | Participants in the EUC group received educational materials on managing anxiety, made available both by mail and through a weblink. They also received a letter encouraging them to discuss treatment options with their VA care providers. Additionally, a note was placed in the participant's electronic medical record to inform their primary care provider (PCP) and most recent Primary Care Mental Health Integration (PCMHI) provider of the presence of anxiety symptoms. Furthermore, EUC participants received four brief monthly check-in calls from study staff to review the resource list and assess current anxiety symptoms, with their providers being alerted in the event of significant anxiety symptoms. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Sex at Birth | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Multigroup Ethnic Identity Measure (MEIM). The MEIM is a self-report measure that asks participants for their self-reported racial/ethnic identity. | Count of Participants | Participants |
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| Current Relationship Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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Participants in the bCBT-A arm were offered 4-9 sessions of measurement-based care, depending on their treatment response by the fourth session. Veterans could receive bCBT-A in person or via VA Video Connect to Home. All participants took part in an initial session where they received psychoeducation on anxiety and the bCBT treatment approach, set goals, and began self-monitoring. Three core skill sessions focused on relaxation, cognitive skills, and exposure techniques followed. All participants received a final wrap-up session to review gains and plan for skill maintenance. |
| OG001 | Enhanced Usual Care (EUC) | Participants in the EUC group received educational materials on managing anxiety, made available both by mail and through a weblink. They also received a letter encouraging them to discuss treatment options with their VA care providers. Additionally, a note was placed in the participant's electronic medical record to inform their primary care provider (PCP) and most recent Primary Care Mental Health Integration (PCMHI) provider of the presence of anxiety symptoms. Furthermore, EUC participants received four brief monthly check-in calls from study staff to review the resource list and assess current anxiety symptoms, with their providers being alerted in the event of significant anxiety symptoms. |
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| Secondary | Overall Anxiety Severity and Impairment Scale (OASIS) | The OASIS will be a secondary measure of anxiety. Unlike the GAD-7, which will be administered by both research staff and PCMHI providers, the OASIS will only be administered by research staff, thereby avoiding response bias that may occur in the clinical setting. The OASIS is a widely used five-item measure of anxiety for primary care settings assessing anxiety frequency, anxiety severity, avoidance behaviors, social interference, and interference at work, school, or home. Each item of the OASIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20. A higher score indicates a poorer outcome. | The number of participants to start a Period is not equal to the number who completed previous Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-, 8-, and 12-month |
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| Secondary | Short Form-12 Physical Component Summary (SF-12-PCS) | The SF-12-PCS is a condensed, self-reported outcome measure assessing the impart of health on an individual's everyday life. Physical Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. | The number of participants to start a Period is not equal to the number who completed previous Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-, 8-, and 12-month |
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| Secondary | Short Form-12 Mental Component Summary (SF12-MCS) | The SF12-MCS is a 12-question, patient reported survey evaluating emotional well-being. Mental Health Composite Scores are computed using the score of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The investigators assessed quality of life using the 12-item Short Form Health Survey for Veterans (SF12V), an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning. | The number of participants to start a Period is not equal to the number who completed previous Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-, 8-, 12-month |
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| 0 |
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | Enhanced Usual Care (EUC) | Participants in the EUC group received educational materials on managing anxiety, made available both by mail and through a weblink. They also received a letter encouraging them to discuss treatment options with their VA care providers. Additionally, a note was placed in the participant's electronic medical record to inform their primary care provider (PCP) and most recent Primary Care Mental Health Integration (PCMHI) provider of the presence of anxiety symptoms. Furthermore, EUC participants received four brief monthly check-in calls from study staff to review the resource list and assess current anxiety symptoms, with their providers being alerted in the event of significant anxiety symptoms. | 0 | 91 | 0 | 91 | 0 | 91 |
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| 8 Month |
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| 12 Month |
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| 4 Month |
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| 8 Month |
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| 12 Month |
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| 4 Month |
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| 8 Month |
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| 12 Month |
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