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临床试验/NCT04724694
NCT04724694
已完成
不适用

Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes Among Primary Care Veterans

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 184 人2021年10月1日

概览

阶段
不适用
干预措施
Brief CBT for Chronic Pain
疾病 / 适应症
Musculoskeletal Pain
发起方
VA Office of Research and Development
入组人数
184
试验地点
1
主要终点
Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up
状态
已完成
最后更新
上个月

概览

简要总结

Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.

注册库
clinicaltrials.gov
开始日期
2021年10月1日
结束日期
2025年1月27日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Veterans age \>=18 and \<=79 years
  • Conversant in English
  • A diagnosis of musculoskeletal pain of \>three months
  • PEG score of \>= 4 on pain intensity item and both interference items at screening
  • BPI interference and pain intensity score of at least 4.0 at baseline
  • If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months
  • If currently prescribed psychiatric medicine, a stable dose in the last two months
  • Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)

排除标准

  • Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.
  • Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.
  • Endorsement of imminent suicide risk
  • Current significant substance use problems (i.e., alcohol, opioids, benzodiazepines, or other drugs)
  • Unstable psychiatric status (e.g., active psychosis, current mania)
  • Diagnosed with major or minor neurocognitive disorder
  • Unwilling to have treatment sessions audio recorded
  • Pending disability claim
  • Recent or planned surgical/interventional procedure for pain

研究组 & 干预措施

Brief CBT for Chronic Pain and treatment as usual

Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.

干预措施: Brief CBT for Chronic Pain

Brief CBT for Chronic Pain and treatment as usual

Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.

干预措施: Treatment as usual

Treatment as usual only

Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.

干预措施: Treatment as usual

结局指标

主要结局

Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up

时间窗: 12-weeks

This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.

次要结局

  • Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up(12-weeks)
  • Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up(12-weeks)
  • Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess 12 Week Follow up(12-weeks)
  • World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up(12-weeks)
  • World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up(12-weeks)
  • World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up(12-weeks)
  • World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health at 12 Week Follow up(12-weeks)

研究点 (1)

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