Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Recruitment Rate (Feasibility)
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary outcomes of a heart rate variability biofeedback (HRVB) intervention among adults with opioid use disorder (OUD) receiving residential treatment. The study aims to learn whether HRVB can be implemented successfully in this setting and whether it may help participants manage stress, emotional regulation, and cravings.
The main questions this study aims to answer are:
Is HRVB feasible and acceptable for adults with OUD in a residential treatment program, as indicated by recruitment, retention, adherence, and participant satisfaction?
Do participants show preliminary improvements in stress, affect, emotional regulation, self-efficacy, and cravings following participation in the HRVB intervention?
Participants will be adults with OUD enrolled in a residential treatment program.
Participants will:
- Complete baseline and post-intervention questionnaires assessing stress, affect, emotional regulation, social support, self-efficacy, and cravings
- Participate in daily HRVB practice using a portable biofeedback device for approximately 3 weeks
- Complete brief daily diary assessments related to mood, stress, and cravings
This is a single-arm pilot study designed to inform the feasibility and future refinement of HRVB as an adjunct intervention for individuals with OUD in residential treatment settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants are
- •adults aged 18 to 65,
- •currently admitted to a transitional living program for opioid use and within the first 30 days of admission
- •voluntarily agree to participate and demonstrate adequate decision-making capacity as determined by the study team during informed consent
- •able to read and speak English,
- •have a clinical diagnosis of OUD at any severity level, whether mild, moderate, or severe,
- •identify opioids as their primary drug of choice
- •should have access to smartphones for daily individual practice of the intervention.
- •must reside at the treatment program for the duration of the study
排除标准
- •inability to provide informed consent,
- •inability to demonstrate adequate decision-making capacity
- •currently having suicidal thoughts or psychotic symptoms
- •history of receiving previous HRVB training,
- •have a serious cardiac condition such as having pacemaker, heart failure or cardiac arrhythmia),
- •a known self-reported diagnosis of dementia, a severe brain injury, or a serious neurological condition(e.g., Parkinson's disease)
- •currently enrolled in any other biofeedback program simultaneously
- •currently taking medications such as MAOIs and alpha/beta blockers or benzodiazepines.
- •Participant recruitment will be conducted at the recruitment site. Individuals younger than 18 or older than 65 years are excluded from participation primarily due to age-related differences in autonomic function and heart rate variability (HRV) regulation. Restricting the sample to adults aged 18-65 allows for more accurate measurement and interpretation of HRV data, thereby reducing potential confounding effects related to age-related physiological differences.
研究组 & 干预措施
HRVB Intervention group
干预措施: Heart rate variability biofeedback (Behavioral)
结局指标
主要结局
Recruitment Rate (Feasibility)
时间窗: From study launch through completion of recruitment
Recruitment feasibility will be assessed as the proportion of eligible individuals who enroll in the HRVB intervention during the recruitment period in the transitional residential treatment setting. Metric: Number of participants enrolled ÷ number of eligible individuals Unit of Measure: Percentage (%) of eligible individuals enrolled Benchmark: ≥ 60% enrollment of eligible individuals
Retention Rate (Feasibility)
时间窗: Time Frame: From enrollment through completion of the 3-week intervention
Description: Retention feasibility will be assessed as the proportion of enrolled participants who complete post-intervention (T2) assessments at the end of the 3-week HRVB intervention. Metric: Number of participants completing T2 ÷ number of participants enrolled Unit of Measure: Percentage (%) of enrolled participants completing T2 Benchmark: ≥ 80% completion of post-intervention assessments
HRVB Practice Adherence (Feasibility)
时间窗: From enrollment through completion of the 3-week intervention
Description: Adherence feasibility will be assessed as the proportion of participants who engage in consistent daily HRVB practice across the intervention period. Self-reported adherence will be corroborated using HeartCloud device data. Metric: Number of participants practicing on ≥70% of intervention days ÷ total number of participants Unit of Measure: Percentage (%) of participants meeting adherence threshold Benchmark: ≥ 70% of participants practice on ≥70% of intervention days
Daily Diary Compliance (Feasibility)
时间窗: From enrollment through completion of the 3-week intervention
Description: Daily diary compliance will be assessed as the proportion of expected ecological momentary assessment (EMA) diary entries completed during the intervention period. Metric: Number of completed diary entries ÷ number of expected diary entries Unit of Measure: Percentage (%) of expected diary entries completed Benchmark: ≥ 80% of daily diary entries completed
Intervention Acceptability Rating (Acceptability)
时间窗: At the post-intervention assessment (T2), immediately following completion of the intervention
Acceptability will be assessed at post-intervention (T2) using a structured 7-item survey evaluating perceived relevance, helpfulness, usability, satisfaction, and likelihood of recommending the intervention. Items are rated on a 5-point Likert scale (1 = strongly disagree/not helpful to 5 = strongly agree/very helpful). Metric: Number of participants rating items as 4 or 5 ÷ total number of respondents Unit of Measure: Percentage (%) of participants endorsing the acceptability threshold Benchmark: ≥ 80% of participants rate the intervention as helpful or very helpful (scores 4-5).
Qualitative Acceptability Feedback (Acceptability)
时间窗: At the post-intervention assessment (T2), immediately following completion
Qualitative acceptability will be assessed using open-ended questions examining perceived benefits, challenges, and recommendations for improvement of the HRVB intervention. Metric: Thematic saturation and frequency of key themes Unit of Measure: Narrative themes categorized as benefits, barriers, and recommendations Benchmark: Identification of actionable themes supporting feasibility and refinement of implementation.
次要结局
- Perceived Sress(Baseline (T1) and 3 weeks after baseline (T2))
- Perceived Affect(Baseline (T1) and 3 weeks after baseline (T2))
- Perceived difficulties in emotional regulation(Baseline (T1) and 3 weeks after baseline (T2))
- Craving for illicit opioids(Baseline (T1) and 3 weeks after baseline (T2))
- Perceived social support(Baseline (T1) and 3 weeks after baseline (T2))
- Self-efficacy to resist substance use(Baseline (T1) and 3 weeks after baseline (T2))
- Autonomic regulation(Baseline (T1) and 3 weeks after baseline (T2))
研究者
Sunny Wonsun Kim, Ph.D
Associate Professor
Arizona State University