Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation

NCT04089670 | Completed

• 1 other identifier: 19-171
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Chiari Malformation

Keywords

Chronic Pain; Acceptance and Commitment Therapy; Sleep Dysfunction; Online Intervention

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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.

• 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

Study Arms (2)

Online Acceptance and Commitment Therapy Intervention

ACTIVE COMPARATOR

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.

Behavioral: Online Acceptance and Commitment Therapy Intervention

Control

NO INTERVENTION

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.

Interventions

Online Acceptance and Commitment Therapy Intervention BEHAVIORAL

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.

Online Acceptance and Commitment Therapy Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kent State University: lead
• Utah State University: collaborator
• Conquer Chiari: collaborator

Study Sites (1)

Kent state University

Kent, Ohio, 44240, United States

Location

Related Publications (21)

• 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.

  PMID: 22035996 BACKGROUND

• 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.

  PMID: 23548250 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

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• Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.

  PMID: 9720850 BACKGROUND

• Cleeland, D. C. S. (2005). The Brief Pain Inventory- Short Form. 38.

  BACKGROUND

• Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.

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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.

  PMID: 22607834 BACKGROUND

• 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.

  PMID: 16300724 BACKGROUND

• 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.

  PMID: 24993763 BACKGROUND

• 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.

  PMID: 23291270 BACKGROUND

• Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16.

  PMID: 21680251 BACKGROUND

• Lin J, Klatt LI, McCracken LM, Baumeister H. Psychological flexibility mediates the effect of an online-based acceptance and commitment therapy for chronic pain: an investigation of change processes. Pain. 2018 Apr;159(4):663-672. doi: 10.1097/j.pain.0000000000001134.

  PMID: 29320375 BACKGROUND

• 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

  BACKGROUND

• Parkitny L, McAuley JH, Walton D, Pena Costa LO, Refshauge KM, Wand BM, Di Pietro F, Moseley GL. Rasch analysis supports the use of the depression, anxiety, and stress scales to measure mood in groups but not in individuals with chronic low back pain. J Clin Epidemiol. 2012 Feb;65(2):189-98. doi: 10.1016/j.jclinepi.2011.05.010. Epub 2011 Sep 1.

  PMID: 21889306 BACKGROUND

• Simister HD, Tkachuk GA, Shay BL, Vincent N, Pear JJ, Skrabek RQ. Randomized Controlled Trial of Online Acceptance and Commitment Therapy for Fibromyalgia. J Pain. 2018 Jul;19(7):741-753. doi: 10.1016/j.jpain.2018.02.004. Epub 2018 Mar 2.

  PMID: 29481976 BACKGROUND

• 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.

  PMID: 23767890 BACKGROUND

• Smith MT, Huang MI, Manber R. Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Clin Psychol Rev. 2005 Jul;25(5):559-92. doi: 10.1016/j.cpr.2005.04.004.

  PMID: 15970367 BACKGROUND

• Tang NK, Goodchild CE, Sanborn AN, Howard J, Salkovskis PM. Deciphering the temporal link between pain and sleep in a heterogeneous chronic pain patient sample: a multilevel daily process study. Sleep. 2012 May 1;35(5):675-87A. doi: 10.5665/sleep.1830.

  PMID: 22547894 BACKGROUND

• 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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• Trompetter HR, Bohlmeijer ET, Veehof MM, Schreurs KM. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial. J Behav Med. 2015 Feb;38(1):66-80. doi: 10.1007/s10865-014-9579-0. Epub 2014 Jun 13.

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MeSH Terms

Conditions

Chronic Pain; Arnold-Chiari Malformation; Parasomnias

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Wake Disorders; Mental Disorders

Study Officials

• Douglas L Delahanty, PhD.

  Kent State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Vice President of Research

Model Details: Two groups are created through randomization to either the treatment group or the control group. The treatment includes 8 online intervention modules that are administered weekly for 8 weeks. A 7-day sleep diary is administered one week prior to the intervention and one week after the intervention. The control group completes the online sleep diaries and all the same assessments as the treatment group. At the end of the 1 month follow-up they are given the opportunity to receive the intervention.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: September 13, 2019
• Study Start: August 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

US (1)