Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Changes in Daily Functioning - Pain
研究概览
简要总结
The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain) manual guided protocol, patient workbook, and therapist training protocol.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old;
- •Willing to adhere to study protocol including treatment sessions and assessments;
- •Individuals have a history of co-morbid opioid use disorder and chronic pain;
- •Cognitively able to participate and give informed consent.
排除标准
- •Acute or unstable psychotic disorder;
- •Psychiatric hospitalization or suicide attempt in the past 3 months
- •Patient has been diagnosed with an unstable cardiovascular condition including: myocardial infarction, arrhythmia, or poorly controlled hypertension in the past 3 months
- •Lack of verbal and written English fluency
- •Over the age of 65 since evidence suggests pain perception alters with age
结局指标
主要结局
Changes in Daily Functioning - Pain
时间窗: Baseline (week 1) to post-treatment assessment time-point (week 14) and to a 1-month post-treatment follow-up assessment for each participant (approximately 4-5 month total time frame per participant)
Multi-dimensional pain inventory - 60 items (participant ratings 0 to 6 on various measures, from none to extreme or from never to very often, related to their pain and functioning); subscales (ratings in each subscale are averaged to form subscale scores): Interference, Support, Pain Severity, Life-Control, Affective Distress, Negative Responses, Solicitous Responses, Distracting Responses, Household Chores, Outdoor Work, Activities Away from Home, Social Activities, General Activity
次要结局
- Changes in Substance Use(Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant))