Examining Different Components of Online Acceptance and Commitment Therapy for Chronic Pain in a Sample of People With Chiari Malformation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in psychological flexibility over time measured by the Acceptance and Action Questionnaire (AAQ).
研究概览
简要总结
Chiari Malformation (CM) is a chronic health condition characterized by brain and spinal malformations and displacements that cause obstruction of cerebrospinal fluid (CSF; Hadley, 2002) circulation. The most common type of CM, CM1, is characterized by the displacement of the cerebellar tonsils more than five millimeters into the foramen magnum (Hadley, 2002). Approximately 215,000 Americans may have CM1, over six times the prevalence of multiple sclerosis (Dilokthornsakul et al., 2016; Speer et al., 2003). Chronic pain is a major problem for patients with CM; (Curone et al., 2017; Garcia et al., 2019). Craniovertebral decompression is the most common surgical intervention for CM1, but it may not be effective in relieving long-term pain and is not recommended for all CM1 patients (Arnautovic et al., 2015; Imperato et al., 2011). In addition to chronic pain, patients with CM also have high levels of depression, anxiety, and sleep dysfunction (Garcia et al., 2019; Lázaro et al., 2018; Watson et al., 2010). Psychological interventions, specifically Acceptance and Commitment Therapy (ACT), have been effective at treating chronic pain when administered online (van de Graaf et al., 2021). We previously found an online self-administered version of ACT to be effective at improving psychological flexibility and chronic pain acceptance in participants with CM (Garcia et al., 2021). In our pilot study (Garcia et al., 2021), participants in the intervention group received phone coaching to improve intervention adherence and use of skills; however, we found that duration of phone coaching did not impact treatment outcomes. We also had excellent retention in the control group. It is unclear whether phone coaching is necessary for treatment engagement or efficacy in groups particularly motivated to seek treatment. If it is not necessary, online ACT can be offered more efficiently and cost-effectively. The proposed study will randomize participants to either ACT+ phone coaching, ACT without coaching, or wait-list control conditions to determine if coaching impacts treatment adherence and outcomes in this population.
Based on power analyses, the sample size will be 111. The sample will be recruited online and randomized to one of the three treatment groups. The intervention will consist of eight modules that are administered weekly over 8 weeks. Follow up assessments will be administered after completion of the intervention, and at one and three months after completion.
详细描述
Chronic pain is a major problem for patients with CM; over 80% report struggling with neck pain, and 41% report long lasting headaches (Curone et al., 2017; Garcia et al., 2019). Acceptance and Commitment Therapy (ACT) has been widely studied in chronic pain populations using both online and face-to-face modalities (van de Graaf et al., 2021; Veehof et al., 2016). The online intervention for our proposed study was developed by a licensed clinical psychologist and has been tested in a variety of populations (Levin et al., 2020, 2020; Levin, Petersen, et al., 2021). Our prior study found that this intervention was effective at improving psychological flexibility and chronic pain acceptance in participants with CM, the primary mechanisms of ACT (Garcia et al., 2021; Hayes et al., 2006) Moreover, our pilot study indicated that participants were satisfied with the program and found the intervention easy to use with no adverse effects (Garcia et al., 2021). In our prior study, participants in the intervention group received phone coaching designed to improve intervention adherence and use of concepts and skills. This was included based on literature showing a positive impact of coaching on adherence and treatment outcomes in online interventions for mental health outcomes (Mohr et al., 2013; Musiat et al., 2021). Additionally, a recent systematic review of online teletherapy for chronic pain found that interventions with higher levels of therapist guidance were more beneficial and had better adherence (Mariano et al., 2021). However, in our study, we found that duration of phone coaching did not impact treatment outcomes, and another recent study using the same online ACT intervention as our pilot study found no effect of coaching on treatment outcomes, program engagement, or program satisfaction among distressed college students (Levin, Krafft, et al., 2021). Our pilot study also had excellent retention in the wait list control group (85.7%), suggesting that this population is highly motivated to remain engaged. It is unclear whether phone coaching is necessary for treatment engagement, satisfaction, or efficacy in groups particularly motivated to seek treatment. If it is not necessary, online ACT can be offered more efficiently and cost-effectively. The proposed study will randomize participants to either phone coaching or no phone coaching conditions in order to determine the extent to which coaching impacts treatment adherence and outcomes in this population. There will be separate randomization by sex.
The scientific aims are as follows:
Aim One:
Investigate the extent to which phone coaching improves the efficacy of an online ACT intervention for chronic pain.
Hypothesis
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)
盲法说明
Single Blind. Outcome assessor online surveys.
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
- •Eligible participants will be at least 18 years old, have been diagnosed by a doctor with Chiari Malformation, and report a pain intensity of at least a 3 on a scale from 1-
- •If they are taking psychotropic medication participants must be stable on their medication for the past 3 months, and they must have access to the internet. Participants must also be willing to commit approximately an hour a week for 8 weeks to engage in the intervention and homework.
排除标准
- •Participants will be excluded if they do not speak English, have a sensory impairment (blindness), are less than 18 years old, are without Internet, are not diagnosed with Chiari Malformation, have not experienced persistent pain over the past 3 months, rate their average pain as at least a 3 on a scale from 1-10, have not been stable on psychotropic medication for the past 3 months, are currently receiving therapy or counseling, have active suicidal ideations, and/or have severe psychiatric disorders including bipolar disorder and schizophrenia. Those unstable on medication, having active suicidal ideations, and severe psychiatric disorders will be excluded because they need a higher level of care than will be provided in an online intervention. We are also excluding those currently in therapy because we would not be able to differentiate the impact of the online intervention vs. the impact of their alternative treatment. Participants in the prior ACT pilot study will also be excluded.
研究组 & 干预措施
Online Acceptance and Commitment Therapy Intervention + Phone Coaching
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. Additionally, each participant will receive a weekly call for the duration of the intervention (i.e., 9 phone calls: one introduction phone call, 8 module related phone calls) from a Master's-level clinical student who will serve as the participants "phone coach." The intervention includes 8 modules: Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). Each module ends with a practice assignment which participants are asked to engage in over the next week.
During the phone coaching calls, the clinical student will be able to help troubleshoot any technical difficulties being experienced, as well as clarify any questions about the material being taught in the intervention.
干预措施: Online Acceptance and Commitment Therapy Intervention + Phone Coaching (Behavioral)
Online Acceptance and Commitment Therapy Intervention without phone coaching
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. Additionally, each participant will receive a weekly call for the duration of the intervention (i.e., 9 phone calls: one introduction phone call, 8 module related phone calls) from a Master's-level clinical student who will serve as the participants "phone coach." The intervention includes 8 modules: Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). Each module ends with a practice assignment which participants are asked to engage in over the next week.
干预措施: Online Acceptance and Commitment Therapy Intervention without phone coaching (Behavioral)
Waitlist Control
Participants in this arm of the study will complete the same sleep diaries and questionnaires at the same time points as the intervention group, but will not be administered the intervention modules and will not receive any phone coaching. When they have completed the 1-month follow-up they will be offered the intervention.
结局指标
主要结局
Change in psychological flexibility over time measured by the Acceptance and Action Questionnaire (AAQ).
时间窗: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
The seven AAQ Items are scored on a scale from 1 (never true) to 7 (always true). Lower scores on this scale indicate greater psychological flexibility, the core mechanism of Acceptance and Commitment Therapy (Bond et al., 2011; Hayes et al., 2006).
Change in pain intensity over time as assessed with the Numeric Rating Scale (NRS).
时间窗: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.]
The NRS has individuals rate their pain from 0 (no pain) to 10 (worst pain imaginable) on four separate time anchors: pain right now, usual level of pain during the last week, best level of pain during the last week, and worst level of pain during the last week (Jensen et al., 1999). Due to a lack of clear consensus on which time anchor to use, all 4 items will be examined separately (Patel et al., 2021).
Change in pain interference over time assessed by the pain interference subscale of the Brief Pain Inventory.
时间窗: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
The 7-item pain interference subscale asks participants to rate how much pain has interfered with their general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life (Cleeland, 2009). Ratings are on a scale of 0 ("Does not interfere") to 10 ("Completely Interferes").
Change in chronic pain acceptance over time assessed by the Chronic Pain Acceptance Questionnaire-Revised (CPAQ).
时间窗: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
The CPAQ is a 20-item scale that assesses acceptance of chronic pain-related thoughts, feelings, and experiences (McCracken et al., 2004). Questions are on a Likert scale ranging from 0 (never true) to 6 (always true). While the total score is indicative of broader acceptance of chronic pain, two subscales have been empirically identified to predict pain-related disability and distress: activities engagement and pain willingness (McCracken et al., 2004; Vowles et al., 2008).
Change in symptoms of depression and anxiety over time assessed by the Depression, Anxiety, and Stress Scale (DASS-21).
时间窗: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
The Depression, Anxiety and Stress Scale (DASS-21) is a 21-item scale that assesses depression, anxiety, and stress (Lovibond \& Lovibond, 1995). The 21 items of the DASS-21 are rated on a scale of 0 ("Did not apply to me at all") to 3 ("Applied to me very much of the time.")
次要结局
- Change in sleep dysfunction over time assessed by the Insomnia Severity Index.(Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.)
- Change in dysfunctional beliefs and attitudes about sleep over time assessed by the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS)-16.(Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.])
- Change in sleep dysfunction assessed by the Sleep Diary.(Assessed at baseline and at the 1 week follow up after the intervention.)
- Percentage of participants who met criteria for Minimal Clinically Important Difference (MCID) in pain scores.(MCID will be calculated for baseline-1 week post intervention, baseline-1 month post intervention, and baseline-3 months post intervention.])