Chronic Pain Clinical Trial
Official title:
Examining Different Components of Online Acceptance and Commitment Therapy for Chronic Pain in a Sample of People With Chiari Malformation
Verified date | June 2023 |
Source | Kent State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 113 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 1-10. 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Kent state University | Kent | Ohio |
Lead Sponsor | Collaborator |
---|---|
Kent State University | The University of Akron, Utah State University |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in psychological flexibility over time measured by the Acceptance and Action Questionnaire (AAQ). | 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). | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up. | |
Primary | Change in chronic pain acceptance over time assessed by the Chronic Pain Acceptance Questionnaire-Revised (CPAQ). | 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). | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up. | |
Primary | Change in pain intensity over time as assessed with the Numeric Rating Scale (NRS). | 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). | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.] | |
Primary | Change in pain interference over time assessed by the pain interference subscale of the Brief Pain Inventory. | 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"). | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up. | |
Primary | Change in symptoms of depression and anxiety over time assessed by the Depression, Anxiety, and Stress Scale (DASS-21). | 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.") | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up. | |
Secondary | Change in sleep dysfunction assessed by the Sleep Diary. | The 7-day sleep diary is a 14-item measure comprised of the 8-question Consensus Sleep Diary core which assesses sleep onset latency, quantity, and quality of sleep; we also added one item to ask participants to estimate how long they slept (Carney et al., 2012). The sleep diary also included 4 additional questions asking participants to rate their arousal, nervousness, feelings of restlessness, pain and mood on a scale of 0 ("Not at all) to 10 ("a lot;" Tang et al., 2012). | Assessed at baseline and at the 1 week follow up after the intervention. | |
Secondary | Change in sleep dysfunction over time assessed by the Insomnia Severity Index. | The Insomnia Severity Index is a 7-item questionnaire that assesses sleep quality and dysfunction. Items are rated on a scale of 0 ("None" or "Not at all interfering") to 4 ("Very Severe" or "Very much interfering;" (Morin et al., 2011) | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up. | |
Secondary | Change in dysfunctional beliefs and attitudes about sleep over time assessed by the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS)-16. | The DBAS is a 16-item questionnaire that assesses the extent to which participants agree with negative or dysfunctional beliefs about sleep. The items are rated on a scale of 0 ("Strongly Disagree") to 10 (Strongly agree") and the items are designed to capture the cognitive component of insomnia (Morin et al., 2007). | Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.] | |
Secondary | Percentage of participants who met criteria for Minimal Clinically Important Difference (MCID) in pain scores. | A minimum of 20% decrease in pain ratings (2-point reduction) will indicate minimum change while a substantial pain reduction will be defined as a 50% or greater decrease (5-point reduction). Pain intensity MCID will be calculated on the 4 NRS pain intensity items individually. For pain interference, a minimum of 1 point decrease will be needed on the pain interference subscale of the Brief Pain inventory (Dworkin et al., 2008; Smith et al., 2020). | MCID will be calculated for baseline-1 week post intervention, baseline-1 month post intervention, and baseline-3 months post intervention.] |
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