Examining Different Components of Online Acceptance and Commitment Therapy for People With Chiari Malformation

NCT05581472 | Unknown

• 1 other identifier: 270
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Chiari Malformation

Keywords

chronic pain; acceptance and commitment therapy; sleep dysfunction; online intervention

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.]

• 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.

• 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 Outcomes (4)

• Change in sleep dysfunction assessed by the Sleep Diary.

  Assessed at baseline and at the 1 week follow up after the intervention.

• 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.]

• 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.]

Study Arms (3)

Online Acceptance and Commitment Therapy Intervention + Phone Coaching

ACTIVE COMPARATOR

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.

Behavioral: Online Acceptance and Commitment Therapy Intervention + Phone Coaching

Online Acceptance and Commitment Therapy Intervention without phone coaching

ACTIVE COMPARATOR

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.

Behavioral: Online Acceptance and Commitment Therapy Intervention without phone coaching

Waitlist 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 + Phone Coaching BEHAVIORAL

The intervention has 8 modules. The modules "Away Moves" and "Letting Go of Control," help to 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. The modules "Noticing Hooks" and "Stepping Back" focus on diffusion, self as context, and mindfulness. While mindfulness is overtly addressed in the module "Stepping Back", it is weaved through each module. The modules "Your Values" and "How You Want to Act" focus on helping participants identify their values. The modules "Goal Setting" and "Making Commitments" focus on committed action. Each module has a practice assignment which participants are asked to engage in over the next week. During the phone coaching calls, the participant will be able to troubleshoot any technical difficulties and ask any questions about the material being taught in the intervention.

Online Acceptance and Commitment Therapy Intervention + Phone Coaching

Online Acceptance and Commitment Therapy Intervention without phone coaching BEHAVIORAL

The intervention has 8 modules. The modules "Away Moves" and "Letting Go of Control," help to 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. The modules "Noticing Hooks" and "Stepping Back" focus on diffusion, self as context, and mindfulness. While mindfulness is overtly addressed in the module "Stepping Back", it is weaved through each module. The modules "Your Values" and "How You Want to Act" focus on helping participants identify their values. The modules "Goal Setting" and "Making Commitments" focus on committed action. Each module has a practice assignment which participants are asked to engage in over the next week.

Online Acceptance and Commitment Therapy Intervention without phone coaching

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kent State University: lead
• Utah State University: collaborator
• The University of Akron: collaborator

Study Sites (1)

Kent state University

Kent, Ohio, 44240, United States

Location

Related Publications (28)

• Arnautovic A, Splavski B, Boop FA, Arnautovic KI. Pediatric and adult Chiari malformation Type I surgical series 1965-2013: a review of demographics, operative treatment, and outcomes. J Neurosurg Pediatr. 2015 Feb;15(2):161-77. doi: 10.3171/2014.10.PEDS14295. Epub 2014 Dec 5.

  PMID: 25479580 BACKGROUND

• 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

• Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.

  PMID: 22294820 BACKGROUND

• Curone M, Valentini LG, Vetrano I, Beretta E, Furlanetto M, Chiapparini L, Erbetta A, Bussone G. Chiari malformation type 1-related headache: the importance of a multidisciplinary study. Neurol Sci. 2017 May;38(Suppl 1):91-93. doi: 10.1007/s10072-017-2915-8.

  PMID: 28527081 BACKGROUND

• Dilokthornsakul P, Valuck RJ, Nair KV, Corboy JR, Allen RR, Campbell JD. Multiple sclerosis prevalence in the United States commercially insured population. Neurology. 2016 Mar 15;86(11):1014-21. doi: 10.1212/WNL.0000000000002469. Epub 2016 Feb 17.

  PMID: 26888980 BACKGROUND

• Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.

  PMID: 18055266 BACKGROUND

• Garcia MA, Allen PA, Li X, Houston JR, Loth F, Labuda R, Delahanty DL. An examination of pain, disability, and the psychological correlates of Chiari Malformation pre- and post-surgical correction. Disabil Health J. 2019 Oct;12(4):649-656. doi: 10.1016/j.dhjo.2019.05.004. Epub 2019 May 21.

  PMID: 31147250 BACKGROUND

• Hadley DM. The Chiari malformations. J Neurol Neurosurg Psychiatry. 2002 Jun;72 Suppl 2(Suppl 2):ii38-ii40. doi: 10.1136/jnnp.72.suppl_2.ii38. No abstract available.

  PMID: 12122202 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

• Imperato A, Seneca V, Cioffi V, Colella G, Gangemi M. Treatment of Chiari malformation: who, when and how. Neurol Sci. 2011 Dec;32 Suppl 3:S335-9. doi: 10.1007/s10072-011-0709-y.

  PMID: 21822700 BACKGROUND

• Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.

  PMID: 10534586 BACKGROUND

• Levin ME, Krafft J, Davis CH, Twohig MP. Evaluating the effects of guided coaching calls on engagement and outcomes for online acceptance and commitment therapy. Cogn Behav Ther. 2021 Sep;50(5):395-408. doi: 10.1080/16506073.2020.1846609. Epub 2021 Jan 12.

  PMID: 33433264 BACKGROUND

• Levin ME, Krafft J, Hicks ET, Pierce B, Twohig MP. A randomized dismantling trial of the open and engaged components of acceptance and commitment therapy in an online intervention for distressed college students. Behav Res Ther. 2020 Mar;126:103557. doi: 10.1016/j.brat.2020.103557. Epub 2020 Jan 22.

  PMID: 32014692 BACKGROUND

• Levin ME, Petersen JM, Durward C, Bingeman B, Davis E, Nelson C, Cromwell S. A randomized controlled trial of online acceptance and commitment therapy to improve diet and physical activity among adults who are overweight/obese. Transl Behav Med. 2021 Jun 17;11(6):1216-1225. doi: 10.1093/tbm/ibaa123.

  PMID: 33289785 BACKGROUND

• Mariano TY, Wan L, Edwards RR, Jamison RN. Online teletherapy for chronic pain: A systematic review. J Telemed Telecare. 2021 May;27(4):195-208. doi: 10.1177/1357633X19871746. Epub 2019 Sep 5.

  PMID: 31488004 BACKGROUND

• McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004 Jan;107(1-2):159-66. doi: 10.1016/j.pain.2003.10.012.

  PMID: 14715402 BACKGROUND

• Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.

  PMID: 23990896 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Morin CM, Vallieres A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep. 2007 Nov;30(11):1547-54. doi: 10.1093/sleep/30.11.1547.

  PMID: 18041487 BACKGROUND

• Musiat P, Johnson C, Atkinson M, Wilksch S, Wade T. Impact of guidance on intervention adherence in computerised interventions for mental health problems: a meta-analysis. Psychol Med. 2022 Jan;52(2):229-240. doi: 10.1017/S0033291721004621. Epub 2021 Nov 22.

  PMID: 34802474 BACKGROUND

• Patel KV, Amtmann D, Jensen MP, Smith SM, Veasley C, Turk DC. Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Rep. 2021 Jan 21;6(1):e784. doi: 10.1097/PR9.0000000000000784. eCollection 2021 Jan-Feb.

  PMID: 33521482 BACKGROUND

• Smith SM, Dworkin RH, Turk DC, McDermott MP, Eccleston C, Farrar JT, Rowbotham MC, Bhagwagar Z, Burke LB, Cowan P, Ellenberg SS, Evans SR, Freeman RL, Garrison LP, Iyengar S, Jadad A, Jensen MP, Junor R, Kamp C, Katz NP, Kesslak JP, Kopecky EA, Lissin D, Markman JD, Mease PJ, O'Connor AB, Patel KV, Raja SN, Sampaio C, Schoenfeld D, Singh J, Steigerwald I, Strand V, Tive LA, Tobias J, Wasan AD, Wilson HD. Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations. Pain. 2020 Nov;161(11):2446-2461. doi: 10.1097/j.pain.0000000000001952.

  PMID: 32520773 BACKGROUND

• Speer MC, Enterline DS, Mehltretter L, Hammock P, Joseph J, Dickerson M, Ellenbogen RG, Milhorat TH, Hauser MA, George TM. Review Article: Chiari Type I Malformation with or Without Syringomyelia: Prevalence and Genetics. J Genet Couns. 2003 Aug;12(4):297-311. doi: 10.1023/A:1023948921381.

  PMID: 26141174 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

• van de Graaf DL, Trompetter HR, Smeets T, Mols F. Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. Internet Interv. 2021 Oct 1;26:100465. doi: 10.1016/j.invent.2021.100465. eCollection 2021 Dec.

  PMID: 34660209 BACKGROUND

• Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.

  PMID: 26818413 BACKGROUND

• Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.

  PMID: 18824301 BACKGROUND

• Rabinowitz EP, Ripley GH, Lemek C, Allen PA, Delahanty DL. High levels of patient self advocacy may confound clinical research in understudied patient populations. J Health Psychol. 2025 Sep;30(10):2816-2822. doi: 10.1177/13591053241286643. Epub 2024 Sep 30.

  PMID: 39345001 DERIVED

Related Links

• Lázaro, 2018
• Lovibond 1995
• Watson, 2010

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind. Outcome assessor online surveys.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups are created through randomization to either intervention alone, intervention plus phone coaching or the control group. The intervention 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: October 12, 2022
• First Posted: October 14, 2022
• Study Start: January 9, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)