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

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

Interventions

BEHAVIORAL

Online Acceptance and Commitment Therapy Intervention + Phone Coaching

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.

BEHAVIORAL

Online Acceptance and Commitment Therapy Intervention without phone coaching

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.

Sponsors & Collaborators

• Utah State University

  collaborator OTHER

• The University of Akron

  collaborator OTHER

• Kent State University

  lead OTHER

Principal Investigators

• Douglas L Delahanty, PhD · Kent State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-09

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• United States

Study Locations