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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.
Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.
Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients: Medication Management (MEDS) | Active Comparator | The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. |
|
| Patients: Behavioral Activation Therapy (BA) | Active Comparator | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
|
| Caregivers: Medication Management (MEDS) | No Intervention | Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months. | |
| Caregivers: Behavioral Activation Psychotherapy (BA) | No Intervention | Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation Therapy | Behavioral | The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression) | 6 months from baseline enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | The SF-12v2 is a 12-item questionnaire used to assess Health-related Quality of Life (HRQoL) from the patient's perspective. The SF-12v2 consists of 12 questions from the SF-36 that evaluate the same eight health domains: physical function, the role-physical, bodily pain, general health, vitality, social function, the role-emotional, and mental health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are norm-based scores ranging from 0 to 100 calculated from the responses to the 12 questions using scoring software from QualityMetric.com. In the general US population, the mean normal score is 50, with a standard deviation (SD) of 10. Higher scores indicate better outcomes with better HRQoL. Health-related Quality of Life - Physical Health as measured by SF-12 physical component and Health |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waguih W IsHak, MD, FAPA | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38231511 | Derived | IsHak WW, Hamilton MA, Korouri S, Diniz MA, Mirocha J, Hedrick R, Chernoff R, Black JT, Aronow H, Vanle B, Dang J, Edwards G, Darwish T, Messineo G, Collier S, Pasini M, Tessema KK, Harold JG, Ong MK, Spiegel B, Wells K, Danovitch I. Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352094. doi: 10.1001/jamanetworkopen.2023.52094. | |
| 33412562 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients: Medication Management (MEDS) | The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. Medication Management: Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. |
| FG001 | Patients: Behavioral Activation Therapy (BA) | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Behavioral Activation Therapy: The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
| FG002 | Caregivers: Medication Management (MEDS) | Caregivers in the medication management group do not participate in the medication management intervention. Rather, the medication management intervention is delivered to patients and the effect of this intervention is on patient's caregivers' burden is measured by the Caregiver Burden Questionnaire. |
| FG003 | Caregivers: Behavioral Activation Psychotherapy (BA) | Caregivers in the behavioral activation group do not participate in the behavioral activation intervention. Rather, the behavioral activation intervention is delivered to patients and the effect of this intervention on patient's caregivers' burden is measured by the Caregiver Burden Questionnaire. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Overall baseline participants include patient participants in each arm, and caregiver participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients: Medication Management (MEDS) | The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. Medication Management: Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression) | Intention-to-treat: We analyzed all participants in both arms who were randomized to their respective intervention | Posted | Mean | Standard Deviation | score on a scale | 6 months from baseline enrollment. |
|
1 year
We collected information about all-cause mortality, serious adverse events, and other adverse events, using a standardized data collection form and summary form where a description of the event was provided. All-cause mortality, serious adverse events, and other (not including serious) adverse events were not monitored/assessed for caregivers. Adverse events were monitored/assessed without regard to the specific adverse event term.
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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 | Patients: Medication Management (MEDS) | The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. Medication Management: Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. Caregivers did not receive active treatment, however they were assessed for caregiver burden using the Caregiver Burden Questionnaire at 3, 6, and 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-Cause Mortality | General disorders | Non-systematic Assessment | Deemed by DSMB as not related to study interventions. |
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For our secondary outcomes of Emergency Department Visits, Hospital Readmissions, and Total Days in the Hospital, we were only able to collect such data for ED visits and hospital admissions that occurred at Cedars-Sinai Medical Center and outside institutions that share data with the Cedars-Sinai Health System. As such, this data may not be complete since patients could potentially have visited different hospitals that we do not know about.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Waguih IsHak | Cedars-Sinai Medical Center | 310-423-3515 | Waguih.IsHak@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2020 | Oct 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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|
|
| Medication Management | Drug | Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. |
|
|
| 3 month, 6 month, and 12 months from baseline enrollment |
| Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | The KCCQ is a 23-item, self-administered instrument that quantifies 6 domains and yields 2 summary scores. The 6 domains are physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The 2 summary scores are the Clinical Summary Score and the Overall Summary Score. The Clinical Summary score includes total symptom and physical function scores to correspond with NYHA Classification. The Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. Domain scores and summary scores are scaled from the raw item scores using a software available from the authors (SPERTUSJ@UMKC.EDU) to a range from 0 (worst) to 100 (best), in which higher scores reflect better heart-failure-specific quality of life and health status. Heart failure-specific quality of life are measured by the KCCQ Overall Summary Score and the Clinical Summary Score . | 3 month, 6 month, and 12 months from baseline enrollment |
| Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | The Caregiver Burden Questionnaire - Heart Failure Version 3.0 (CBQ-HF) is a quantitative survey of 26 questions covering the past four weeks of the caregiver's experience is evaluated as caregiver burden. The scale uses a 5-point Likert severity scale (Not at all=0, A little=1, Somewhat=2, Quite a lot=3, A lot=4) assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens. The score is summed from all the questions for each domain, and then summed to a total score that ranges from 0 (no burden) to 104 (worst burden), in which higher scores reflect worse outcomes of higher burden on the caregiver. We will measure the caregiver burden measured by the CBQ-HF. | 3 month, 6 month, and 12 months from baseline enrollment |
| Mean Number of Emergency Department Visits | We recorded the number of emergency department visits. | 3 month, 6 month, and 12 months from baseline enrollment |
| Mean Number of Readmissions (Hospitalization) | We recorded the number of readmissions to the hospital. | 3 month, 6 month, and 12 months from baseline enrollment |
| If Hospitalized, Mean Number of Total Days in the Hospital | We recorded the number of total days in the hospital if they were hospitalized. | 3 month, 6 month, and 12 months from baseline enrollment |
| Mortality Was Also Measured | We recorded mortality data on the patients. | 3 month, 6 month, and 12 months from baseline enrollment |
| Derived |
| IsHak WW, Korouri S, Darwish T, Vanle B, Dang J, Edwards G, Black JT, Aronow H, Kimchi A, Spiegel B, Hedrick R, Chernoff R, Diniz MA, Mirocha J, Manoukian V, Harold J, Ong MK, Wells K, Hamilton M, Danovitch I. Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244453. doi: 10.1371/journal.pone.0244453. eCollection 2021. |
| Withdrawal by Subject |
|
| Death |
|
| BG001 | Patients: Behavioral Activation Therapy (BA) | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Behavioral Activation Therapy: The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
| BG002 | Caregivers: Medication Management (MEDS) | Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
| BG003 | Caregivers: Behavioral Activation Therapy (BA) | Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Medications | Number | Number of patients taking the medication |
|
| Location of Recruitment | Count of Participants | Participants |
|
| OG001 | Behavioral Activation Therapy | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Behavioral Activation Therapy: The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
|
|
| Secondary | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | The SF-12v2 is a 12-item questionnaire used to assess Health-related Quality of Life (HRQoL) from the patient's perspective. The SF-12v2 consists of 12 questions from the SF-36 that evaluate the same eight health domains: physical function, the role-physical, bodily pain, general health, vitality, social function, the role-emotional, and mental health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are norm-based scores ranging from 0 to 100 calculated from the responses to the 12 questions using scoring software from QualityMetric.com. In the general US population, the mean normal score is 50, with a standard deviation (SD) of 10. Higher scores indicate better outcomes with better HRQoL. Health-related Quality of Life - Physical Health as measured by SF-12 physical component and Health | Intention to treat: We analyzed all participants in both arms who were randomized to their respective intervention | Posted | Mean | Standard Deviation | score on a scale | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
| Secondary | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | The KCCQ is a 23-item, self-administered instrument that quantifies 6 domains and yields 2 summary scores. The 6 domains are physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The 2 summary scores are the Clinical Summary Score and the Overall Summary Score. The Clinical Summary score includes total symptom and physical function scores to correspond with NYHA Classification. The Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. Domain scores and summary scores are scaled from the raw item scores using a software available from the authors (SPERTUSJ@UMKC.EDU) to a range from 0 (worst) to 100 (best), in which higher scores reflect better heart-failure-specific quality of life and health status. Heart failure-specific quality of life are measured by the KCCQ Overall Summary Score and the Clinical Summary Score . | Intention to treat: We analyzed all participants in both arms who were randomized to their respective intervention | Posted | Mean | Standard Deviation | score on a scale | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
| Secondary | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | The Caregiver Burden Questionnaire - Heart Failure Version 3.0 (CBQ-HF) is a quantitative survey of 26 questions covering the past four weeks of the caregiver's experience is evaluated as caregiver burden. The scale uses a 5-point Likert severity scale (Not at all=0, A little=1, Somewhat=2, Quite a lot=3, A lot=4) assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens. The score is summed from all the questions for each domain, and then summed to a total score that ranges from 0 (no burden) to 104 (worst burden), in which higher scores reflect worse outcomes of higher burden on the caregiver. We will measure the caregiver burden measured by the CBQ-HF. | The number analyzed in each row differs from the overall number analyzed because of missing caregiver questionnaire data at each timepoint of 3-months, 6-months, and 12-months | Posted | Mean | Standard Deviation | score on a scale | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
| Secondary | Mean Number of Emergency Department Visits | We recorded the number of emergency department visits. | Using a Zero Inflated Poisson (ZIP) Model, at 3, 6, and 12 months, the mean ratios of ED visits were compared for patients with heart failure who received BA to those who received MEDS. | Posted | Mean | Full Range | Mean ED visits | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
|
| Secondary | Mean Number of Readmissions (Hospitalization) | We recorded the number of readmissions to the hospital. | Using a Zero Inflated Poisson (ZIP) Model, at 3, 6, and 12 months, the mean ratios of Hospital Admissions were compared for patients with heart failure who received BA to those who received MEDS. | Posted | Mean | Full Range | Mean Hospital Readmissions | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
|
| Secondary | If Hospitalized, Mean Number of Total Days in the Hospital | We recorded the number of total days in the hospital if they were hospitalized. | Using a Zero Inflated Poisson (ZIP) Model, the ratio of means were compared for total days in the hospital for BA vs. MEDS, at 3, 6, and 12 months respectively. | Posted | Mean | Full Range | Mean Number ofTotal Days in the Hospital | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
|
| Secondary | Mortality Was Also Measured | We recorded mortality data on the patients. | Posted | Count of Participants | Participants | 3 month, 6 month, and 12 months from baseline enrollment |
|
|
|
|
| 36 |
| 208 |
| 36 |
| 208 |
| 0 |
| 208 |
| EG001 | Patients: Behavioral Activation Therapy (BA) | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Behavioral Activation Therapy: The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Caregivers did not receive active treatment, however they were assessed for caregiver burden using the Caregiver Burden Questionnaire at 3, 6, and 12 months. | 27 | 208 | 27 | 208 | 0 | 208 |
|
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| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| SF-12v2 Physical Component Score at 6-months |
|
| SF-12v2 Physical Component Score at 12-months |
|
| SF-12v2 MentalComponent Score at Baseline |
|
| SF-12v2 Mental Component Score at 3-months |
|
| SF-12v2 Mental Component Score at 6-months |
|
| SF-12v2 Mental Component Score at 12-months |
|
| KCCQ Overall Summary Score at 12-months |
|
| KCCQ Clinical Summary Score at 3-months |
|
| KCCQ Clinical Summary Score at 6-months |
|
| KCCQ Clinical Summary Score at 12-months |
|
| CBQ-HF Overall Score at 3-months |
|
|
| CBQ-HF Overall Score at 6-months |
|
|
| CBQ-HF Overall Score at 12-months |
|
|
| Means ED visits at 12-months |
|
Emergency Department visits AT 6 MONTHS |
| Zero Inflated Poisson (ZIP) Model |
| 0.008 |
The a priori threshold for statistical significance is p<0.05 |
| ratio of means |
| 0.70 |
| 2-Sided |
| 95 |
| 0.60 |
| 0.86 |
For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator. |
| Superiority |
| Emergency Department visits AT 12 MONTHS | Zero Inflated Poisson (ZIP) Model | 0.0001 | The a priori threshold for statistical significance is p<0.05. | ratio of means | 0.73 | 2-Sided | 95 | 0.62 | 0.85 | For the ratio of means for ED visits , BA is numerator and MEDS is the denominator. | Superiority |
| Mean Hospital Readmissions at 12-months |
|
| Mean Number of Total Days in the Hospital at 12-months |
|
Days in the Hospital at 6 MONTHS |
| Zero Inflated Poisson (ZIP) Model |
| 0.005 |
The a priori threshold for statistical significance is p<0.05. |
| ratio of means |
| 0.81 |
| 2-Sided |
| 95 |
| 0.75 |
| 0.87 |
For the ratio of means, BA is numerator and MEDS is the denominator. |
| Superiority |
| Days in the Hospital AT 12 MONTHS | Zero Inflated Poisson (ZIP) Model | <0.0001 | The a priori threshold for statistical significance is p<0.05. | ratio of means | 0.64 | 2-Sided | 95 | 0.60 | 0.68 | For the ratio of means, BA is the numerator and MEDS is the denominator. | Superiority |
| Total Number of Deaths at 12-months |
|