Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
Condition: Chronic Pain; Chiari Malformation
MeSH terms: Arnold-Chiari Malformation; Congenital Abnormalities; Chronic Pain
Study type: Interventional

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.
    

Detailed description: 
      Chronic pain is extremely prevalent with 20% of adults in the US reporting symptoms
      (Dahlhamer, 2018). Further, when accounting for lost productivity and direct health care
      costs, the financial burden of chronic pain has been estimated to be $560-$630 billion
      annually (Gaskin & Richard, 2011). A myriad of factors contribute to chronic pain including
      psychological symptoms and sleep. Though psychological symptoms often co-occur with chronic
      pain with rates estimated to be as high as 50% (Kroenke et al., 2011), chronic pain co-occurs
      at an even higher rate with sleep dysfunction (89%) (van Hecke, Torrance, & Smith, 2013).
      Sleep is believed to have a reciprocal relationship with pain, such that pain impacts sleep
      and sleep impacts future pain (M. T. Smith, Huang, & Manber, 2005) reciprocal relationship
      makes sleep an essential aspect of chronic pain that warrants attention in interventions. One
      intervention that has shown particular promise in treating chronic pain is Acceptance and
      Commitment Therapy (ACT).

      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 (chiaristudy@gmail.com).

      (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.
    

Intervention name(s): Online Acceptance and Commitment Therapy Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pain; Acceptance and Commitment Therapy; Sleep Dysfunction; Online Intervention