Video Teleconference (VTC) Emotional Awareness and Expression Therapy (vEAET) for Older Veterans With Chronic Musculoskeletal Pain: An Initial, Uncontrolled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The Satisfaction with Therapy and Therapist Scale-Revised
研究概览
简要总结
An uncontrolled pilot in which Veterans age 60-95 years with chronic musculoskeletal (MSK) pain will undergo Emotional Awareness and Expression Therapy (EAET) delivered over video teleconference (VTC; together vEAET). This study aims to obtain early implementation outcomes, as well as evaluate efficacy and estimated effect sizes.
详细描述
For this pilot, vEAET will be provided to outpatient Veterans age 60-95 years with chronic MSK pain in order to obtain early implementation and clinical outcomes (i.e. acceptability, feasibility, appropriateness, fidelity, and effectiveness). Each Veteran will be provided a VTC capable tablet and technological support from a research coordinator as a strategy to overcome technology based obstacles and obtain feasibility data. Veterans will receive one 90-minute individual session of vEAET plus eight 90-minute weekly group sessions of vEAET, all delivered over VTC to their homes. Assessments will be performed at baseline, posttreatment, and 2-month follow-up remotely using OutcomeMD (Los Angeles, CA), a HIPAA-compliant, VA-approved web-based platform. The entire study will be performed without any in-person visits.
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
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible Veterans are age 60-95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychotherapy based on previous research: low back, neck, leg, or pelvic pain; temporomandibular joint disorders; fibromyalgia; tension headaches; or any combination of these disorders.
排除标准
- •Musculoskeletal conditions likely to respond surgical or pharmacologic treatment: hip or knee osteoarthritis, leg pain greater than back pain (to exclude radiculopathy), electromyography-confirmed "tunnel" syndrome (e.g., carpal tunnel syndrome), gout, neuralgias, migraine, and cluster headaches;
- •Non-musculoskeletal pain conditions: autoimmune disease that typically generates pain (e.g., rheumatoid arthritis), cancer pain, sickle cell disease, burn pain, infection associated with pain, and cauda equina syndrome;
- •The following conditions or circumstances: severe psychiatric disorder such as schizophrenia or bipolar I disorder not controlled with medications, active suicide or violence risk, active severe alcohol or substance use disorder, substantial cognitive impairment based on chart review, previously completed EAET, currently enrolled in another psychological treatment for chronic pain, currently in pain-related litigation or applying for pain-related compensation or compensation increase (e.g., VA service connection for chronic pain), unable to fluently read or converse in English, no internet access.
结局指标
主要结局
The Satisfaction with Therapy and Therapist Scale-Revised
时间窗: 8-Week Post-treatment
Satisfaction with therapy subscale is the summation of six items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Satisfaction with therapist subscale is the summation of six items, each scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction), yielding a total score between 6 and 30. Overall satisfaction is an additional single item scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction). The two subscales and the overall satisfaction item are each reported separately.
Credibility/Expectancy Questionnaire
时间窗: Baseline
Logical Credibility/Expectancy subscale is the average of four self report items, three of which are scored 1-9 (1 = not at all logical; 9 = very logical). A fourth Logical Credibility/Expectancy item reflects the percentage of functioning improvement participants think will occur. Feeling Credibility/Expectancy subscale is the average of four self report items, three of which are scored 1-9 (1 = not at all logical; 9 = very logical). A fourth Feeling Credibility/Expectancy item reflects the percentage of functioning improvement participants feel will occur. The two subscales are each reported separately.
Functional Assessment of Currently Employed Technology Scale (FACETS)
时间窗: Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up
The summation of ten items related to ease of use of technology, each scored 1-6 (1 = never use a technology; 5 = easy/regular use of a technology), yielding a total score between 10 and 60.
Percent of Group Therapy Sessions Attended
时间窗: 8 Weeks
Number of sessions each participant attends divided by 8 sessions (total number of sessions available to attend).
次要结局
- Coping Strategies Questionnaire (CSQ)(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- PROMIS-Global Health(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Anger Discomfort Scale(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety Short Form 7a(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Brief Pain Inventory (BPI)(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- PROMIS-Depression Short Form 8a(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- PANAS Emotion Differentiation(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- PROMIS-Pain Interference Short Form 8a(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Property Association Task(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Patient Global Impression of Change (PGIC)(8-Week Post-treatment)
- Test of Self-Conscious Affect 3-Short Version (TOSCA-3)(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Social Connectedness Scale-Revised(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)
- Survey of Pain Attitudes (SOPA)(Change from Baseline, 8-Week Post-treatment, 2-Month Follow Up)