Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial).
研究概览
简要总结
The central objective of research is to examine the feasibility and acceptability of an 8-month single-arm behavioral intervention (i.e., EMPOWER) among overweight/obese middle-aged and older adults with moderate-to-high impact low back pain. Intervention content will focus on standard behavioral weight loss treatment and cognitive-behavioral pain coping therapy with a focus on environmental reward and positive affect.
详细描述
Chronic low back pain (cLBP) is the leading cause of disability worldwide and is one of the top reasons for seeking healthcare. High-impact low back pain is particularly problematic, defined as chronic pain accompanied by significant restrictions in work, social, and/or self-care activities for six months or more. High-impact pain is associated with greater pain-related disability, opioid use, and healthcare costs compared to pain of lower impact. Thus, efforts to reduce chronic pain impact have become a public health initiative. Low back pain and overweight/obesity are highly comorbid; overweight and obese individuals are up to 43% more likely to have cLBP compared to normal weight individuals. Together, the additive effects of overweight/obesity and chronic pain may play a larger role in increasing the risk for other adverse health-related comorbidities.
The aim of this exploratory study is to examine the feasibility and acceptability of an integrated pain and weight management intervention (EMPOWER) for middle-aged and older adults with moderate-to-high impact low back pain by addressing mechanisms of environmental reward and positive affect. Forty adults (ages 45-80 years) with comorbid overweight/obesity (BMI≥25 kg/m2) and moderate-to-high impact cLBP will be assigned to an 8-month intervention, whereby they will receive a group- and telephone-based program featuring integrated behavioral weight loss treatment and cognitive-behavioral pain coping therapy. To address the key mechanisms of environmental reward and positive affect, the proposed intervention will incorporate systematic pleasant activity scheduling and values-clarification techniques. Assessments will be conducted at baseline and at the 4- and 8-month time points.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45-80 years of age
- •Have a BMI≥25kg/m2
- •Endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold), knees, or hips
- •Pain must occur on at least 50% of the days in the previous six months
- •Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale ranging from 0-10)
- •Pain impact must be rated as moderate to severe
- •Study physician reviews medical record and declares patient medically appropriate for exercise protocol
排除标准
- •Current participation in another psychological treatment or structured weight loss program
- •Severe psychiatric illness not adequately controlled by medication or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence)
- •Presence of chronic, malignant pain (e.g., cancer)
- •Significant cognitive impairment (<26) on the Montreal Cognitive Assessment (MoCA)
- •Inability to read and write English
- •Currently undergoing radiation or chemotherapy for cancer
- •Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF)
- •Currently pregnant or breastfeeding, or planning to become pregnant during the study time period
- •Back, knee, or hip surgery within the past six months of study entry (or planned surgical interventions for pain during forecasted study participation)
- •If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for >4 weeks prior to the baseline assessment
- •Blood pressure higher than 180/100 mm Hg at baseline assessment
- •Has had bariatric surgery in the past year or is planning to have it in the next year
- •If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid arthritis), the study physician will be consulted to determine eligibility
研究组 & 干预措施
In-Person (or Remote) Intervention Visits
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions will be delivered every-other week and phone calls will occur every-other week (during weeks with no group). Sessions will be administered by a study interventionist with bachelors- or masters-level training and certification in health education or a related field (e.g., Certified Health Education Specialist), and materials will be developed to be appropriate for delivery by this level of training, given the potential for greater availability of these types of health professionals.
干预措施: In-Person (or Remote) Intervention (Behavioral)
结局指标
主要结局
Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial).
时间窗: Assessed at each session (every other week) up to 8 months
Treatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. The total scale is create by taking the mean of the items, and has a possible range of 0 (minimum) to 8 (maximum) score. There are no subscales. Higher scores indicate greater treatment engagement.
Global Treatment Engagement
时间窗: Baseline to 4 months
Number of participants who completed the intervention (defined as attending the final group session)
Participant Satisfaction
时间窗: Month 8
A single treatment satisfaction item ("In an overall, general sense, how satisfied are you with the intervention program you received?"). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Treatment Credibility
时间窗: Baseline
Treatment Expectation Questionnaire: 7-item study-developed questionnaire assessing the credibility and reasonableness of the intervention. Items are rated on a 0 to 10 scale. A mean score was calculated for the questionnaire. Higher scores were indicative of greater treatment credibility.
Enrollment Rate
时间窗: 63 Weeks
Number of participants enrolled per week during active recruitment.
Participant Retention
时间窗: Baseline to 8 Months
Percentage of enrolled participants who complete the 8-month time-point.
Participant Satisfaction
时间窗: Month 4
A single treatment satisfaction item ("In an overall, general sense, how satisfied are you with the intervention program you received?"). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Enrollment Rate
时间窗: Baseline to Week 1
Percentage of participants who enroll that commence treatment.
次要结局
- Body Weight Change(4 months)
- Pain Impact Change(4 months)
- Pleasant Activity Engagement(Baseline to 8 Months)
- Meaningful Activity Participation Change(4 months)
- Global Treatment Engagement(Baseline to 8 months)