Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
NCT ID: NCT04089670
Last Updated: 2021-01-05
Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-08-15
2020-10-30
Brief Summary
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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.
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Detailed Description
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ACT is not a set of techniques, but rather an orientation. This orientation focuses on living a fulfilling life by way of living in line with one's values. In addition to living a life based on values, 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) (S. C. Hayes, Luoma, Bond, Masuda, \& Lillis, 2006). Since the focus is on an orientation rather than specific techniques, ACT can be used as a transdiagnostic intervention, targeting multiple symptoms at one time. As previously noted, chronic pain is a complex diagnosis, with many interacting factors including psychological symptoms, sleep, and decreased daily functioning. ACT effectively treats the complex presentation of chronic pain. Chronic pain already costs society billions of dollars annually and administering psychological interventions are expensive and may not be available to all those in need. Online ACT interventions remedy this issue by providing services to those where treatment may not be readily available for a fraction of the price.
Though a handful of studies have explored different online ACT interventions, and found them to be efficacious, however, they have been unable to flexibly address individual differences in symptom presentations as they present the same information regardless of the participant's symptoms (Buhrman et al., 2013; S. Hayes et al., 2014; Kristjánsdóttir et al., 2013; Lin, Klatt, McCracken, \& Baumeister, 2018; Simister et al., 2018; Trompetter, Bohlmeijer, Veehof, \& Schreurs, 2015). Additionally, all prior online ACT interventions for chronic pain focused on pain primarily, providing examples and metaphors around the experience of pain. The aim is to administer an intervention that broadly teaches ACT philosophies without focusing only on pain, addressing individual differences in symptom presentation and allowing for personalization. The goal is to address chronic pain but to also facilitate the generalization of skills to comorbid conditions that often perpetuate the experience of chronic pain (i.e., depression, anxiety, and sleep dysfunction). Efficacy will be assessed through reductions in pain interference as well as comorbid conditions (i.e., sleep dysfunction, anxiety and depression).
Chronic pain is a commonly reported symptom of Chiari Malformation (CM). This under-researched diagnosis is characterized by the cerebellar tonsils descending 5mm or more into the spinal canal and impacts approximately 3.25 million people or 1% of the US population (B. W. Smith et al., 2013). Although chronic pain is commonly reported in CM, the etiology of a symptomatic presentation is not fully understood, and there is no direct relationship between the extent of descension of the cerebellar tonsils and pain. Regardless of elucidating the etiology of pain in CM, those with this complex chronic pain diagnosis would likely benefit from psychological and behavioral based interventions. Further, no ACT based intervention has been administered to a sample with Chiari Malformation. The purpose of the current study is to assess the efficacy of an online broad ACT intervention on a sample with Chiari Malformation.
Aim 1: Determine the efficacy and breadth of an online ACT intervention in decreasing pain interference, sleep dysfunction, depression, and anxiety.
Hypothesis 1: The treatment group will report significantly less pain interference, sleep dysfunction, depression, and anxiety compared to the control group.
Aim 2: Assess psychological flexibility as a mechanism of ACT. Hypothesis 2: Psychological flexibility will mediate the trajectories in pain interference, sleep dysfunction, depression, and anxiety over time.
The following is a summary of the protocol:
(Part 1): (Both Treatment \& Waitlist Control Groups) Consent will be established via an online form. Once consent is acquired a set of questionnaires covering demographics, as well as quality of life, pain interference, pain acceptance, anxiety, depression, stress, and sleep; taking approximately 30 - 45 minutes will be completed. Internet access is required to complete these questionnaires on a computer, tablet, or mobile phone.
(Part 2): (Both Treatment \& Waitlist Control Groups) Next, a 7-day sleep diary will be completed. A Qualtrics link will be emailed out each morning (the email will be sent out by midnight the night prior) that will lead to a 2-5 minute survey (11 questions). This survey is to be completed as close to waking as possible to obtain the most accurate information. Once the final day of the sleep diary is completed, randomization into the treatment or control group will occur. The treatment will begin the following Friday after the completion of the sleep diary.
(Part 3): (Treatment Group alone) Once a week, for the next 8 weeks, a short battery of questionnaires, followed by the online intervention (taking a combined total of approximately 30-45 minutes a week) will be completed. The Qualtrics link will be sent via email every Friday morning. If the assessment and intervention has not been completed by the end of day 4 (Monday), a phone call will serve as a reminder and to answer any technical or unresolved issues. Each online intervention ends with a practice assignment for the remainder of the week. The treatment group will receive a weekly call from a Master's-level clinical student; the time of this call will be set up online during the first session in Part 3. During the call will serve to help troubleshoot any technical difficulties, as well as clarify any questions about the material being taught in the intervention.
(Waitlist Control Group) Each week for the next 8 weeks a short battery of questionnaires taking approximately 10-15 minutes will be completed. Technical issues will be remedied through communication with the the study email ([email protected]).
(Part 4): (Both Treatment \& Waitlist Control Groups) At the beginning of the 9th week, an immediate follow-up set questionnaires (same as in Part 1) will be administered.
(Part 5): (Both Treatment \& Waitlist Control Groups) Next, a 7-day sleep diary will again be completed, taking approximately the 2-5 minutes (11 questions), and completed as close to waking as possible to provide the most accurate information.
(Part 6) (Both Treatment \& Waitlist Control Groups) 1-month after completing the intervention the same battery as in Part 1 and Part 4 taking about 30 - 45 minutes will be completed.
(Waitlist control group) Upon completion of the 1-month follow-up assessment, the waitlist control group will be offered the opportunity to take part in the online intervention.
(Part 7) (Treatment Group only) 3-months after completing the intervention, a final Qualtrics link to complete the same battery as in Part 1, 4, and 6 taking about 30 - 45 minutes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Online Acceptance and Commitment Therapy Intervention
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. Each module has a practice assignment at the end with the goal of having the participant engage in the material over the next week. 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." During the call 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.
Online Acceptance and Commitment Therapy Intervention
The intervention includes 8 modules (i.e, Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). "Away Moves" and "Letting Go of Control," helps establish creative hopelessness, where one abandons futile struggles against negative internal experiences and accepts new solutions. These two modules also help identify experiential avoidance and focus on acceptance. "Noticing Hooks" and "Stepping Back" focus on defusion, self as context, and mindfulness. While, mindfulness is overtly addressed in the module "Stepping Back" it is weaved through each module. "Your Values" and "How You Want to Act" focus on helping participants identify their values. "Goal Setting" and "Making Commitments" focus on committed action. Each module ends with a practice assignment which participants are asked to engage in over the next week.
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.
No interventions assigned to this group
Interventions
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Online Acceptance and Commitment Therapy Intervention
The intervention includes 8 modules (i.e, Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). "Away Moves" and "Letting Go of Control," helps establish creative hopelessness, where one abandons futile struggles against negative internal experiences and accepts new solutions. These two modules also help identify experiential avoidance and focus on acceptance. "Noticing Hooks" and "Stepping Back" focus on defusion, self as context, and mindfulness. While, mindfulness is overtly addressed in the module "Stepping Back" it is weaved through each module. "Your Values" and "How You Want to Act" focus on helping participants identify their values. "Goal Setting" and "Making Commitments" focus on committed action. Each module ends with a practice assignment which participants are asked to engage in over the next week.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Utah State University
OTHER
Conquer Chiari
UNKNOWN
Kent State University
OTHER
Responsible Party
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Douglas L. Delahanty
Professor and Associate Vice President of Research
Principal Investigators
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Douglas L Delahanty, PhD.
Role: PRINCIPAL_INVESTIGATOR
Kent State University
Locations
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Kent state University
Kent, Ohio, United States
Countries
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References
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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.
Buhrman M, Skoglund A, Husell J, Bergstrom K, Gordh T, Hursti T, Bendelin N, Furmark T, Andersson G. Guided internet-delivered acceptance and commitment therapy for chronic pain patients: a randomized controlled trial. Behav Res Ther. 2013 Jun;51(6):307-15. doi: 10.1016/j.brat.2013.02.010. Epub 2013 Mar 14.
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Cleeland, D. C. S. (2005). The Brief Pain Inventory- Short Form. 38.
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Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
Hayes S, Hogan M, Dowd H, Doherty E, O'Higgins S, Nic Gabhainn S, MacNeela P, Murphy AW, Kropmans T, O'Neill C, Newell J, McGuire BE. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial. BMJ Open. 2014 Jul 2;4(7):e005092. doi: 10.1136/bmjopen-2014-005092.
Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist-feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain: randomized controlled trial. J Med Internet Res. 2013 Jan 7;15(1):e5. doi: 10.2196/jmir.2249.
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Lovibond, S. H., Lovibond, P. F., & Australia, P. F. of. (1995). Manual for the depression anxiety stress scales. Retrieved from http://trove.nla.gov.au/version/46688692
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Smith BW, Strahle J, Bapuraj JR, Muraszko KM, Garton HJ, Maher CO. Distribution of cerebellar tonsil position: implications for understanding Chiari malformation. J Neurosurg. 2013 Sep;119(3):812-9. doi: 10.3171/2013.5.JNS121825. Epub 2013 Jun 14.
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Taylor R, Lovibond PF, Nicholas MK, Cayley C, Wilson PH. The utility of somatic items in the assessment of depression in patients with chronic pain: a comparison of the Zung Self-Rating Depression Scale and the Depression Anxiety Stress Scales in chronic pain and clinical and community samples. Clin J Pain. 2005 Jan-Feb;21(1):91-100. doi: 10.1097/00002508-200501000-00011.
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Other Identifiers
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19-171
Identifier Type: -
Identifier Source: org_study_id
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