Mechanisms of Psychosocial Treatments for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- Change in Pain Interference (Micro-level Change)
研究概览
简要总结
Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Behavioral Activation (BA). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments. Treatment moderators will also be explored.
详细描述
The purpose of this randomized controlled trial is to evaluate the mechanisms of cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA) as treatments for individuals with chronic pain who endorse low back pain as a primary or secondary pain problem. Participants (240 individuals) will be randomly assigned to eight (8), 1.5 hour telehealth group sessions of (1) CT, (2) MM, or (3) BA. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. Follow-up macro-level assessments will be conducted at 3- and 6-months post-treatment. The study will address two aims.
Primary Objective: The objective of the proposed research is to examine the mechanisms of cognitive therapy (CT), mindfulness meditation training (MM), and behavioral activation (BA) [Aim 1; Primary]. After ensuring that there is at least a small effect of time on early treatment changes in the three mechanism variables, researchers will determine the extent to which late-treatment improvement in primary outcome (pain interference) associated with CT, MM, and BA is predicted by early-treatment changes in cognitive content (i.e., pain catastrophizing), cognitive process (i.e., non-judgment), and/or activity level (i.e., ActiGraph "activity counts").
Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity counts are significantly associated with late treatment improvements in pain interference.
Hypothesis 1b: The Shared Mechanisms Model hypothesizes that if changes in cognitive content, cognitive process, and activity levels are shared mechanisms across the three treatments, then treatment condition will have small and non-significant effects on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be similar; Shared Mechanisms Model).
Hypothesis 1c: The Specific Mechanisms Model hypothesizes that if changes in content, process, and activity level are mechanisms specific to CT, MM, and BA, respectively, then treatment condition will have a significant effect on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be different, with CT having the largest effects on early treatment decreases in catastrophizing, MM having the largest effects on early treatment increases in non-judgment, and BA having the largest effects on early treatment increases in activity level). Further, later improvement in the primary outcome will be predicted by different mechanism variables as a function of treatment condition; that is, late treatment changes in pain interference will be substantially and uniquely predicted by early treatment changes in: (1) cognitive content (i.e., pain catastrophizing) in CT but not in MM or BA; (2) cognitive process (i.e., non-judgment) in MM but not in CT or BA; and (3) activity level in BA but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome (Specific Mechanisms Model).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Endorse having low back pain as a primary or secondary pain problem in the past 6 months;
- •Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
- •Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
- •Chronic pain interference for general activities ≥3 on a 10-point scale for the past 3 months;
- •Able to read, speak, and understand English;
- •If currently taking analgesic or psychotropic medication, medications must have been stabilized for ≥4 weeks prior to this study; and
- •Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
排除标准
- •Primary pain condition is headache;
- •Severe cognitive impairment;
- •Current alcohol or substance dependence;
- •Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
- •Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
- •Significant pain from a recent surgery or injury;
- •Pain condition for which surgery has been recommended and is planned;
- •Any planned surgery, procedure, or hospitalization that may conflict with or otherwise influence participation in the study;
- •Currently receiving or had received other psychosocial treatments for any pain condition;
- •Current or past participation in a research study with treatment components that may overlap those in the current study;
- •Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
- •Psychiatric hospitalization within the past 6 months;
- •Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
- •Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
- •Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.
研究组 & 干预措施
Cognitive Therapy (CT) Condition
Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
干预措施: Cognitive Therapy (CT) (Behavioral)
Mindfulness Meditation (MM) Condition
Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
干预措施: Mindfulness Meditation (MM) (Behavioral)
Behavioral Activation (BA) Condition
Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
干预措施: Behavioral Activation (BA) (Behavioral)
结局指标
主要结局
Change in Pain Interference (Micro-level Change)
时间窗: Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores.
Change in Pain Interference (Macro-level Change)
时间窗: Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx
Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed for a total raw score from 5-25. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data.
次要结局
- Change in Pain Intensity (Micro-level)(Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported)
- Change in Mood (Micro-level)(Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported)
- Change in Physical Function(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Sleep Quality(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Depression Severity(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Anxiety Severity(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Medication Use(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Pain Intensity (Macro-level)(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
- Change in Mood (Macro-level)(Collected via phone at pre-treatment, immediately post- the 4-week treatment period, and at 3- and 6-mos after Tx)
研究者
Mark Jensen
Professor, School of Medicine: Rehabilitation Medicine
University of Washington