UnknownNot Applicable

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

United States113 participantsStarted 2023-01-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ex…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in psychological flexibility over time measured by the Acceptance and Action Questionnaire (AAQ).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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.

Timeframe: 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).

Timeframe: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.

Trial details

NCT IDNCT05581472

SponsorKent State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

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