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Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.
Depression predicts high rates of morbidity/mortality among acute coronary syndrome (ACS) patients. Part of this relationship is explained by a poor profile of behavioral risk factors (i.e., smoking,physical activity, medication adherence, diet). An integrated treatment targeting both depressed mood and multiple behavioral risk factors could be highly effective in reducing post-ACS mortality. Behavioral Activation for depression may be an ideal counseling treatment for this since it has recently shown promise for facilitating behavioral risk factor changes in ACS patients with depression (K23HL107391). The current study adapts this manual targeting post-ACS depressed mood and smoking cessation to target depression and multiple behavioral risk factors post-ACS. This study will be an open trial (N=20) to test the feasibility and acceptability of our procedures and obtain initial indications of efficacy. This study hypothesizes that 1) the BA-HD manual and study procedures will be feasible and acceptable to post-ACS patients with depressed mood as measured by self-report, recruitment/retention rate, and post- treatment qualitative interviews and 2) that participants will experience clinically significant improvements in depressed mood and behavioral risk factor profile. The long-term goal of this research is to improve long-term survival rates following ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Behavioral activation for health and depression (BA-HD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral activation for health and depression (BA-HD) | Behavioral | Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes). |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Measured by the Client Satisfaction Questionnaire | This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction. | At 12 weeks |
| Treatment Engagement Measured by Sessions Attended | Throughout the study we will measure engagement by tracking attendance of treatment sessions. | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments | Study retention will be tracked by measuring the number of participants who complete the follow-up assessments | At 12 weeks |
| Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Busch, PhD | Hennepin Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35113860 | Derived | Gathright EC, Vickery KD, Ayenew W, Whited MC, Adkins-Hempel M, Chrastek M, Carter JK, Rosen RK, Wu WC, Busch AM. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. PLoS One. 2022 Feb 3;17(2):e0261490. doi: 10.1371/journal.pone.0261490. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Behavioral activation for health and depression (BA-HD) Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Behavioral activation for health and depression (BA-HD) Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes). |
| 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 | Acceptability Measured by the Client Satisfaction Questionnaire | This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale | At 12 weeks |
|
12 weeks
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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 | Treatment | Behavioral activation for health and depression (BA-HD) Behavioral activation for health and depression (BA-HD): Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Busch | Hennepin Healthcare | 6128736681 | andrew.busch@hcmed.org |
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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 | Jan 28, 2020 | Feb 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2022 | Mar 8, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2020 | Jan 20, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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Twenty subjects will be given the intervention according to the treatment manual.
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Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms. |
| At 12 weeks |
| Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised) | Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale 10-item. Score range is 0-30 with higher scores indicating higher depression symptoms. | At 12 weeks |
| Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire) | The Medical Outcomes Study Patient Adherence Questionnaire will be used to assess adherence to behavior change goals.10 items related to cardiac health will be scored. Items are rated on a 1-6 scale. Because not all items will be relevant to all participants, the average score across the relevant items for each participant will be presented. Higher scores indicating greater adherence to healthcare provider recommendations. | At 12 weeks |
| 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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| Primary | Treatment Engagement Measured by Sessions Attended | Throughout the study we will measure engagement by tracking attendance of treatment sessions. | Posted | Mean | Standard Deviation | sessions attended | At 12 weeks |
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| Secondary | Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments | Study retention will be tracked by measuring the number of participants who complete the follow-up assessments | Posted | Count of Participants | Participants | At 12 weeks |
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| Secondary | Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9) | Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | At 12 weeks |
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| Secondary | Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised) | Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale 10-item. Score range is 0-30 with higher scores indicating higher depression symptoms. | Posted | Mean | Standard Deviation | score on a scale | At 12 weeks |
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| Secondary | Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire) | The Medical Outcomes Study Patient Adherence Questionnaire will be used to assess adherence to behavior change goals.10 items related to cardiac health will be scored. Items are rated on a 1-6 scale. Because not all items will be relevant to all participants, the average score across the relevant items for each participant will be presented. Higher scores indicating greater adherence to healthcare provider recommendations. | Posted | Mean | Standard Deviation | score on a scale | At 12 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |