A Pilot Study on Mindfulness for Pain and Mental Health Outcomes
概览
- 阶段
- 不适用
- 干预措施
- Mindfulness-Based Cognitive Therapy (MBCT)
- 疾病 / 适应症
- Chronic Pain
- 发起方
- Canandaigua VA Medical Center
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Treatment acceptability
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk of suicide.
详细描述
The investigators are seeking to develop a combined intervention, MBCT-S/P, to focus on both improving functioning and mitigating suicide risk in veterans with chronic pain. The investigators plan to test the new manual's feasibility and acceptability in a sample of veterans experiencing chronic pain and suicidal ideation. Participants will be randomized to either the MBCT-S/P condition (n=38) or the Education control condition (n=38) to assess additional aspects of study feasibility. The investigators also plan to assess a variety of clinical outcomes including suicidal ideation, pain interference in activities, and opioid use. Participants will complete questionnaires pre-treatment, and 1-, 3-, and 6-months post-treatment.
研究者
入排标准
入选标准
- •English-speaking veterans
- •Ages 18 years and older
- •Understand informed consent
- •Report pain that occurs on at least half the days for six months or more
- •Score at least a 4 on each item of the three items on a brief pain intensity and interference measure
- •To meet the minimum threshold for suicide risk, veterans must meet at least one of the following: (1) endorse at least a 1 ("several days") on item 9 ("thoughts of you would be better off dead, or thoughts of hurting yourself in some way" in the past 2 weeks) of the Patient Health Questionnaire-9 (PHQ-9), (2) endorse at least "death ideation" in the last 3 months as measured by the Columbia Suicide Severity Rating Scale, or (3) report a suicide attempt in the last 6 months.
排除标准
- •An active severe substance use disorder (SUD)
- •Documented schizophrenia, active psychosis, or mania
- •Upcoming surgeries
- •Uncontrolled medical conditions
- •Intent to carry out a plan for suicide.
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy (MBCT)
MBCT delivered over the course of 10, \~60 minute sessions
干预措施: Mindfulness-Based Cognitive Therapy (MBCT)
Health Education
Health education sessions delivered over the course of 10, \~60 minute sessions
干预措施: Health Education
结局指标
主要结局
Treatment acceptability
时间窗: 1-month post-treatment
The Abbreviated Acceptability Rating Profile assesses the extent to which participants agree with 8 statements about the intervention. Scores range from 1 to 6 with higher scores indicating higher acceptability.
Pain Interference and intensity
时间窗: baseline to 6 months post-treatment follow-up
Pain interference and intensity will be measured using the Brief Pain Inventory. Four items assessing current, average, worst, and least pain experienced. Pain interference is assessed over 7 items across various life domains. Items are rated from 0 to 10 with higher scores indicating more severe pain intensity and greater interference in activities due to pain.
Depression
时间窗: baseline to 6 months post-treatment follow-up
The Patient Health Questionnaire-9, a 9-item measure assessing frequency of depression symptoms in the last week. Rating scale is from 0 to 3 with higher scores indicating more frequent depression symptoms.
Suicide risk
时间窗: baseline to 6 months post-treatment follow-up
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale, which assesses presence and severity of suicidal ideation and behaviors in one's lifetime, over a specified period, and since the last visit. Presence of suicidal thoughts and behaviors are scored as either present (0) or absent (1) and severity is indicated as the most severe suicidal thought or behavior endorsed (from 0-none to 5-suicide attempt). Higher scores indicate more severe suicidal ideation and behaviors.
Interpersonal Needs
时间窗: baseline to 6 months post-treatment follow-up
The Interpersonal Needs Questionnaire is a 12-item questionnaire measuring level of belonging and feeling like a burden to others. Items are rating on a scale ranging from 1 to 7 with higher scores indicate greater interpersonal conflict.
次要结局
- Pain catastrophizing(baseline to 6 months post-treatment follow-up)
- Mindfulness(baseline to 6 months post-treatment follow-up)
- Pain acceptance(baseline to 6 months post-treatment follow-up)
- Health-related Quality of Life(baseline to 6 months post-treatment follow-up)
- Pain-related self-efficacy(baseline to 6 months post-treatment follow-up)
- Fear of pain(baseline to 6 months post-treatment follow-up)