Chronic Pain Clinical Trial
Official title:
Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
NCT number | NCT04089670 |
Other study ID # | 19-171 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2019 |
Est. completion date | October 30, 2020 |
Verified date | December 2020 |
Source | Kent State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Twenty percent of US adults report chronic pain symptoms. Both psychological symptoms and sleep issues commonly co-occur with chronic pain. Chronic pain is a frequently reported symptoms of Chiari Malformation (CM); however, the cause of pain symptoms is not fully understood, and pain is not associated with the extent of neural abnormality in CM. ACT is not a set of techniques, but rather a way of thinking. ACT encourages acceptance, as opposed to avoidance of unwanted feelings, all in the context of mindfulness (i.e., being aware of one's present environment and in tune with internal thoughts and emotions). ACT has been found to be successful at reducing pain perceptions and targeting multiple symptoms at one time. However, ACT has not been examined in CM and it is unknown whether ACT will improve sleep as well as pain-related symptoms. The purpose of the current study is to assess the efficacy of an online ACT intervention at reducing pain interference and sleep dysfunction symptoms in a sample with CM. It is hypothesized that CM patients may benefit from Acceptance and Commitment Therapy (ACT). More specifically it is hypothesized that the treatment group will report significantly less pain interference and psychological flexibility compared to the control group. It is also hypothesize that ACT will mediate the relationship between sleep dysfunction and pain interference. Based on power analyses the sample size will be 56. The sample will be recruited online and randomized to the treatment or control group. The intervention will consist of eight modules that are administered weekly over eight weeks. Additionally, a 7-day sleep diary will be administered the week prior to the intervention and the week after the intervention. Follow up assessments will be administered upon completion of the 8-week intervention (at the beginning of week 9), 1-month after, and 3 months after the completion of the intervention.
Status | Completed |
Enrollment | 52 |
Est. completion date | October 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Fluent in English - Chiari Malformation - Access to the internet - Be willing to commit approximately an hour a week for 8 weeks to engage in the intervention and homework - Experience persistent pain for a minimum of 3-months - Rate their pain intensity as greater than a 3 on a scale from 1-10 - Be stable on psychotropic medication for the past 3 months (if taking psychotropic medication) Exclusion Criteria: - Blindness - Currently receiving Acceptance or Commitment Therapy or Cognitive Behavioral Therapy - Have active suicidal ideations - Diagnosed with a severe psychiatric disorder including bipolar disorder and schizophrenia |
Country | Name | City | State |
---|---|---|---|
United States | Kent state University | Kent | Ohio |
Lead Sponsor | Collaborator |
---|---|
Kent State University | Conquer Chiari, Utah State University |
United States,
Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain interference assessed by the Brief Pain Inventory Short-form over time | This 9-item inventory assesses pain severity and pain interference over the past 24 hours. "Worst," "least," "average," and "current" pain severity are assessed. Pain interference items are measured on a scale from 0 - 10 (0 = Does not interfere, 10 = Completely interferes) and assesses the degree of pain interference in seven daily activities including general activity, walking, work, mood, enjoyment of life, relationships with others, and sleep. Prior research has demonstrated good internal validity and reliability in chronic pain samples. | Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention | |
Primary | Change in psychological flexibility assessed by the Acceptance and Action Questionnaire II over time | This 7-item inventory is measured on a Likert scale (1 = never true, 7 = always true) and is the most commonly utilized measure of experiential avoidance and psychological flexibility. There is no specified time domain that this questionnaire evaluates. This measure assesses negative evaluations of emotions, avoidance of difficult thoughts and emotions, and behavioral modifications while in the context of challenging thoughts or feelings and has demonstrated good validity, and test re-test reliability | Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention | |
Primary | Change in sleep dysfunction assessed by the Insomnia Severity Index over time | This 7-item index is used to capture perception of nocturnal and diurnal symptoms of insomnia over the past week. It specifically examines difficulties initiating sleep, maintaining sleep, and waking up too early, as well as satisfaction with current sleep, the perceived impact poor sleep has on quality of life and daily functioning, and distress related with sleep difficulties. | Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention | |
Primary | Change in sleep dysfunction assessed by the Daily Sleep Diary over time | This 12-question daily sleep diary assesses sleep duration, efficiency, and quality over the past night, these questions were used in a previous study (Tang, Goodchild, Sanborn, Howard, & Salkovskis, 2012). Questions include bedtime, rise time, how long it took to fall asleep, number of wake times (disrupted sleep maintenance), and length of time asleep. Additionally, a rating of quality of sleep (0 = very poor, 10 = very good), cognitive arousal (i.e., racing thoughts prior to bed), somatic arousal (i.e., feeling restless or jittery prior to bed), level of current pain (0 = no pain at all, 10 = a lot of pain), predicted amount of pain over the next day (0 = no pain at all, 10 = a lot of pain), and mood (0 = very bad mood, 10 = very good mood) is assessed. | Assessed for 7 days prior to the intervention and for 7 days following the intervention. | |
Primary | Change in depression and anxiety assessed by the Depression Anxiety and Stress Scale-21 over time | This 21-item measure that assesses depression, anxiety, and stress levels over the past week (Lovibond, Lovibond, & Australia, 1995). Internal consistencies for depression, anxiety, and stress in prior research has been good (Taylor, Lovibond, Nicholas, Cayley, & Wilson, 2005). In chronic pain samples the scale has demonstrated good internal consistency at the group level (Parkitny et al., 2012). Additionally, this measure does not include somatic symptoms in the depression scale, which prevents the depression score from being artificially inflated based on pain symptoms. | Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention |
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