Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The Credibility and Expectancy Questionnaire
概览
简要总结
The goal of this clinical trial is to pilot an adaptation of mindfulness-based cognitive therapy for chronic pain and early cognitive decline. The main questions it aims to answer in a later fully powered randomized controlled trial are:
- Is an adaptation of mindfulness-based cognitive therapy for older Black adults able to improve quality of life?
- Will an adapted mindfulness based cognitive therapy reduce pain interference to a greater degree than a traditional health enhancement program?
详细描述
Co-morbid chronic pain and early cognitive decline is common among older Black adults and this co-morbidity worsens physical and cognitive function. Access to evidence based non-pharmacological management is limited. Mindfulness based cognitive therapy (MBCT) is an evidence-based, non-pharmacological intervention that could address the chronic pain and early cognitive decline co-morbidity among older Black adults, but it requires tailoring. The proposed study will establish the feasibility, acceptability and credibility of Feeling of Being, a cultural adaptation of MBCT aimed at the chronic pain and early cognitive decline co-morbidity among older Black adults in the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adult (age ≥ 50)
- •All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa
- •Pain in muscles, joints, bones, or associated soft tissues (NRS\>4) lasting longer than 3 months
- •Early Cognitive Decline (subjective or MCI)
- •Telephone Interview for Cognitive Status-41 score ≥ 26
- •Functional Activities Questionnaire score \< 9
- •English fluency/literacy
- •Ability and willingness to participate via in-person and video
- •Willing to provide informed consent and comply with all aspects of the protocol
排除标准
- •Current substance abuse/dependence
- •Significant cognitive impairment
- •History of more than 8 sessions of cognitive-behavioral therapy
- •History of previous training in mindfulness or undergoing counseling more than once a month
- •History of or current diagnosis of psychosis
- •Active suicidal ideation or self-harm within the past 90 days
研究组 & 干预措施
Mindfulness-based cognitive therapy
干预措施: Mindfulness-based cognitive therapy (Behavioral)
结局指标
主要结局
The Credibility and Expectancy Questionnaire
时间窗: At enrollment
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6). Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).
The Client Satisfaction Questionnaire
时间窗: Administered at the end of treatment at 8 weeks.
The 3-item version of the Client Satisfaction Questionnaire (CSQ-3) is scored by summing responses from its three core items. It consists of empirically selected items measuring key aspects of service satisfaction, each rated on a 4-point Likert scale (1 = lowest satisfaction to 4 = highest, with directionality adjusted as needed). Total scores range from 3 to 12, with higher values indicating greater satisfaction; no reverse scoring or subscales are required.
The Credibility and Expectancy Questionnaire
时间窗: From enrollment to 3 months from the end of treatment at 8 weeks
This scale measures participant expectations around the study's positive outcomes, with measures ranging from 0 (not at all expected) to 9 (extremely expected). A higher score indicate greater trust in the study design and an openness to potential benefits.
The Client Satisfaction Questionnaire
时间窗: Administered at the end of treatment at 8 weeks and at the three month follow up visit
Three item scale measuring patient satisfaction with the program. Scores for each item range from 1 (unsatisfied) to 4 (very satisfied).
Modified Patient Global Impression of Change
时间窗: At end of 8 week program (post test) and again at 3 month follow up visit.
The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains. Each domain uses a single ordinal item rated on a 6-point scale: Very Much Improved (coded 5), Much Improved (4), Minimally Improved (3), No Change (2), Minimally Worse (1), or Much Worse (0). The range per domain is 0 (worst, Much Worse) to 5 (best, Very Much Improved), with higher scores indicating greater perceived improvement. Domains are analyzed individually as mean scores (no total computed), where values \>2.5 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.
次要结局
- Telephone Interview for Cognitive Status (41-point Version)(From enrollment to 3 months from the end of treatment at 8 weeks.)
- The Everyday Cognition Scale (12-item Version)(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Measure of Current Status Part A(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Numerical Rating Scale(From enrollment to 3 months from the end of treatment at 8 weeks.)
- PROMIS Physical Function(From enrollment to 3 months from the end of treatment at 8 weeks.)
- PROMIS Anxiety(From enrollment to 3 months from the end of treatment at 8 weeks)
- PROMIS Emotional Support(From enrollment to 3 months from the end of treatment at 8 weeks)
- Cognitive and Affective Mindfulness Scale-Revised(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Chronic Pain Acceptance Questionnaire(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Pain Self-Efficacy Questionnaire(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Pain Catastrophizing Scale(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Tampa Kinesiophobia Scale(From enrollment to 3 months from the end of treatment at 8 weeks.)
- PROMIS Depression(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Telephone Interview for Cognitive Status (41-point version)(From enrollment to 3 months from the end of treatment at 8 weeks.)
- The Everyday Cognition Scale (12-item version)(From enrollment to 3 months from the end of treatment at 8 weeks.)
研究者
Tony V. Pham, MD
Principal Investigator and Psychiatrist
Massachusetts General Hospital