Healthy Heart Habits (H^3)
|ClinicalTrials.gov Identifier: NCT04158219|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Depression||Behavioral: Behavioral activation for health and depression (BA-HD)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Twenty subjects will be given the intervention according to the treatment manual.|
|Masking:||None (Open Label)|
|Official Title:||Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome|
|Actual Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Behavioral activation for health and depression (BA-HD)
Behavioral: 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).
- Acceptability measured by the Client Satisfaction Questionnaire [ Time Frame: At 12 weeks ]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.
- Treatment engagement measured by number of sessions attended [ Time Frame: At 12 weeks ]Throughout the study we will measure engagement by tracking attendance of treatment sessions.
- Study retention measured by percentage completion of assessments [ Time Frame: At 12 weeks ]Study retention will be tracked by measuring the percentage of participants who complete follow-up assessments.
- Depression symptoms as measured by PHQ-9 (Patient Health Quetionnaire-9) [ Time Frame: At 12 weeks ]Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms.
- Depression symptoms as measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised) [ Time Frame: At 12 weeks ]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.
- Composite behavioral risk factor adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire) [ Time Frame: At 12 weeks ]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, score range is 10-60 with higher scores indicating greater adherence to healthcare provider recommendations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158219
|Contact: Andrew M Busch, PhD||612-873-6681||Andrew.Busch@hcmed.org|
|Contact: Michelle L Chrastek, MPH||612-873-5364||Michelle.Chrastek@hcmed.org|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55415|
|Contact: Michelle L Chrastek, MPH 612-873-5364 Michelle.email@example.com|
|Sub-Investigator: Katherine D Vickery, MD, MSc|
|Principal Investigator:||Andrew M Busch, PhD||Hennepin Healthcare|