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临床试验/NCT05204576
NCT05204576已完成不适用

Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management

Yale University6 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
6
主要终点
Change in PROMIS 6-item Pain Interference Short Form

研究概览

简要总结

The investigators plan to develop and pilot test an integrated, web-based cognitive behavioral approach and then conduct a randomized clinical trial evaluating its efficacy relative to standard care in a large and diverse sample of individuals with chronic pain treated with buprenorphine or methadone. The new program will retain key components of Dr. Carroll's computer-based training for cognitive-behavioral therapy (CBT4CBT), including its emphasis on teaching cognitive and behavioral coping skills in an engaging way and focus on the 5 A's of MAT (Adherence, Attendance, Abstinence, Alternate Activities and Accessing support); it will add components from Dr. Heapy's COPES (Cooperative Pain Education and Self-Management) intervention (self-management of chronic pain, with daily surveys via text that monitor pain intensity and interference, physical activity, and skills practice) and modify existing CBT4CBT modules to address the complex interplay between pain and drug use in this population, emphasizing the development of generalizable skills. A randomized clinical trial evaluating CBT4CBT-COPES will be conducted in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or buprenorphine) who have chronic pain, in a 3-month randomized clinical trial with a 6-month follow-up, comparing it to standard treatment alone. The primary retention outcome will be adherence with agonist treatment; the primary pain outcome will be the PROMIS 6-item Pain Interference Short Form.

详细描述

Evaluate the efficacy of CBT4CBT-COPES versus standard care (treatment as usual) at 3 months (primary endpoint) among 160 individuals with OUD and chronic pain enrolled in OAT at the Liberation clinics. The primary outcome will be adherence to OAT (defined as continuous and verified enrollment at the 3-month timepoint); the primary pain outcome will be pain interference as measured by the PROMIS 6-item Pain Interference Short Form. Hypothesis 1a: Individuals randomized to CBT4CBT-COPES will have greater retention at the 3-month point than those assigned to standard care. Hypothesis 1b: CBT4CBT-COPES will be associated with greater reductions in pain interference at the 3-month point.

2. Conduct a 6-month follow-up to evaluate the durability of effects on the primary outcomes. The investigators hypothesizes CBT4CBT-COPES will be associated with greater adherence and reduced pain interference compared with standard care at the 3 and 6-month follow-ups (6 and 9 months post randomization).

Procedures Initial Screening by Project Manager or Research Assistant: Individuals enrolled in the buprenorphine or methadone programs at Liberation will be informed of the study via flyers, group meetings, or their clinicians. Individuals who indicate they are interested in hearing more about the study will be offered a meeting with the research staff. At the first interview, the research staff will provide an overview of the study and obtain written informed consent. The investigators use a multiple-choice test to assess participants' comprehension of the protocol, with ample time to review questions to assure understanding of the protocol, consent, and treatments offered. After determination of eligibility and informed consent, pre-treatment assessments will be completed. Randomization will occur as soon as participants have achieved a therapeutic dose of buprenorphine or methadone.

Urn randomization. To increase the likelihood that treatment groups are balanced with respect to demographic variables (gender, race), as well as likely prognostic variables (severity of opioid use disorder as moderate or severe via DSM-5 OUD symptom count, initial opioid experience of heroin versus prescription opioids, buprenorphine versus methadone treatment, pain severity (mild, moderate vs. severe) as operationalized by NRS average weekly pain rating). Participants will be assigned to treatment conditions through urn randomization using a Microsoft Access program developed and implemented successfully in multiple previous trials.

Treatment phase: Treatment conditions are described in detail below. Study treatments will last 12 weeks. During the treatment phase, all participants will meet weekly with the research assistant for completion of self-report and interview assessments preferably in-person, but with the option of virtual meetings. Breath and urine sample collection will be taken by the research assistant at this time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants will be 18 years of age or older
  • Meet DSM-5 criteria for OUD
  • Enrolled in methadone or buprenorphine treatment at Liberation
  • Have at least moderate-intensity chronic pain as indicated by a score of ≥ 4 over the past week on the 0-10 Numerical Rating Scale
  • Have pain on at least half of the days of the prior six months (indicating chronicity);
  • Self-reported ability to walk at least one block (for the exercise component of CBT4CBT-COPES

排除标准

  • Inability to read, write, and speak English at a third grade level (for reading informed consent)
  • Untreated or inadequately treated bipolar or psychotic disorder or current suicide risk as identified by Structured Clinical Interview for DSM-5 (SCID-5)
  • Life threatening health conditions that would impede participation (e.g., end stage renal failure, malignant cancer requiring chemotherapy excluding melanoma)
  • Planned surgical treatment related to pain
  • Pending legal action or planned relocation that makes it unlikely they would be able to complete the study

研究组 & 干预措施

Standard care treatment as usual (TAU)

No Intervention

Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

CBT4CBT-Copes

Experimental

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.

干预措施: CBT4CBT COPES (Behavioral)

结局指标

主要结局

Change in PROMIS 6-item Pain Interference Short Form

时间窗: Up to 36 weeks

Pain interference is measured using the PROMIS 6-item Pain Interference Short Form. The range on the PROMIS Pain Form is 0 - 24, where 24 is the highest score and highest measure of pain. It will be measured at Weeks 12, 16, 24 and 36 weeks.

Adherence to opioid agonist treatment (OAT)

时间窗: Up to 36 weeks

Adherence to opioid agonist treatment (OAT) will be verified by TimeLine Follow-back and clinic medical records of dates of medication taken, prescriptions filled and pick up. Individual adherence will be measured as a count. It will be measured at Weeks 12, 16, 24 and 36 weeks.

Percent Participants Active in Medications for Opioid Use Disorder (MOUD) Treatment

时间窗: At 3, 6 and 9 months post treatment

Participants active in MOUD treatment will be verified by TimeLine Follow-back and clinic medical records of dates of medication taken, prescriptions filled and pick up.

Change in PROMIS 6-item Pain Interference Short Form

时间窗: Baseline and 12, 24, 36 weeks

Pain interference is measured using the PROMIS 6-item Pain Interference Short Form. The score range on the PROMIS Pain Form is 6-30, where the highest score is the highest measure of pain interference. Summed raw responses (1-5 scale per item) are converted into a standardized T-score (mean 50, SD 10), where higher scores indicate greater pain interference (worse functioning).

次要结局

  • Drug Use(Up to 36 weeks)
  • Mean Days of Any Drug Use(Baseline to Week 12)
  • Mean Days of Any Drug Use(Week 12 up to Week 36)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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