Clinical trial NCT05581472: Examining Different Components of Online Acceptance and Commitment Therapy for People With Chiari Malformation
Official title: Examining Different Components of Online Acceptance and Commitment Therapy for Chronic Pain in a Sample of People With Chiari Malformation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Chiari Malformation
Keywords: chronic pain
acceptance and commitment therapy
sleep dysfunction
online intervention
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Utah State University
name: The University of Akron
First posted: 2022-10-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Chronic pain is a major problem for patients with CM; over 80% report struggling with neck pain, and 41% report long lasting headaches (Curone et al., 2017; Garcia et al., 2019). Acceptance and Commitment Therapy (ACT) has been widely studied in chronic pain populations using both online and face-to-face modalities (van de Graaf et al., 2021; Veehof et al., 2016). The online intervention for our proposed study was developed by a licensed clinical psychologist and has been tested in a variety of populations (Levin et al., 2020, 2020; Levin, Petersen, et al., 2021). Our prior study found that this intervention was effective at improving psychological flexibility and chronic pain acceptance in participants with CM, the primary mechanisms of ACT (Garcia et al., 2021; Hayes et al., 2006) Moreover, our pilot study indicated that participants were satisfied with the program and found the intervention easy to use with no adverse effects (Garcia et al., 2021). In our prior study, participants in the intervention group received phone coaching designed to improve intervention adherence and use of concepts and skills. This was included based on literature showing a positive impact of coaching on adherence and treatment outcomes in online interventions for mental health outcomes (Mohr et al., 2013; Musiat et al., 2021). Additionally, a recent systematic review of online teletherapy for chronic pain found that interventions with higher levels of therapist guidance were more beneficial and had better adherence (Mariano et al., 2021). However, in our study, we found that duration of phone coaching did not impact treatment outcomes, and another recent study using the same online ACT intervention as our pilot study found no effect of coaching on treatment outcomes, program engagement, or program satisfaction among distressed college students (Levin, Krafft, et al., 2021). Our pilot study also had excellent retention in the wait list control group (85.7%), suggesting that this population is highly motivated to remain engaged. It is unclear whether phone coaching is necessary for treatment engagement, satisfaction, 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 phone coaching or no phone coaching conditions in order to determine the extent to which coaching impacts treatment adherence and outcomes in this population. There will be separate randomization by sex.

The scientific aims are as follows:

Aim One:

Investigate the extent to which phone coaching improves the efficacy of an online ACT intervention for chronic pain.

Hypothesis

1. Participants receiving ACT+ Coaching and ACT only will have increased pain acceptance and psychological flexibility as well as improvement on pain intensity, pain interference, depression, and anxiety than participants in the waitlist control group. We do not expect significant differences between the two treatment groups.

Aim Two:

Identify the effect that ACT has on sleep dysfunction and dysfunctional beliefs and attitudes about sleep.

Hypotheses:

1. Participants receiving ACT+ Coaching and ACT only will have more improvement on dysfunctional beliefs and attitudes about sleep and sleep dysfunction than participants in the waitlist control group. Again, we do not expect significant differences between the two treatment groups.
2. Reduction in sleep dysfunction will be moderated by sleep hygiene practices such that participants with better sleep hygiene will improve in sleep functioning while those with poor sleep hygiene will remain stable or have worsening sleep dysfunction.

The following is a summary of the protocol:

Once recruited, participants will be randomized into the ACT+ coaching group, ACT only group, or the wait-list control. Randomization will be made using an online random number generator. The waitlist control group will receive the same compensation as the intervention groups while in the waitlist control condition. Upon completion of the 8-weeks of questionnaires followed by the 1-month follow up, the waitlist control group will be offered the treatment. Compensation will be in the form of e-gift cards sent to the participant's email, allowing for timely compensation. Compensation will be sent within one week of participants completing each time point.

(Part 1): (Both Treatment \& Waitlist Control Groups) Once the participant has signed and submitted the online consent form, they will be asked to complete a set of questionnaires assessing demographics, quality of life, pain interference, pain acceptance, anxiety, depression, stress, and sleep. The survey will take approximately 45 - 60 minutes. Internet access is required to complete these questionnaires on a computer, tablet, or mobile phone.

(Part 2): (Both Treatment \& Waitlist Control Groups) Next, participants will be asked to complete a sleep diary daily for 7 days. A Qualtrics link will be emailed to participants each morning (the email will be sent out by midnight the night prior). By clicking on the link, participants will be taken directly to the 2-5-minute survey. Participants are asked to complete this short survey (11 questions) as close to waking as possible to provide the most accurate information. If the participant has not completed the daily diary by noon an additional reminder email will be send out. Once the final day of the sleep diary is completed, participants will be randomly assigned to either the treatment or waitlist control group and will begin on the following Friday. There will be separate randomization by biological sex.

After random assignment, participants will be sent an additional document to sign which contains the specific information about the time commitment for their assigned group. For instance, individuals in the ACT+ coaching group will be informed of the weekly phone call commitment while participants in the ACT only group will not. A participants' signature will be needed in order to proceed with the study.

(Part 3): (Both Treatment Groups) Once a week, for the next 8 weeks, participants will be asked to complete a short battery of questionnaires, followed by the online intervention taking a combined total of approximately 30 - 35 minutes a week. The Qualtrics link will be sent to each participant's email address every Friday morning with the expectation that they will complete the survey and intervention as soon as possible over the next 3 days. If the assessment and intervention has not been completed by the end of day 4 (Monday), participants will receive a phone call to 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.

(Treatment Group + Phone Coaching) If a participant is assigned to the treatment group with phone coaching, they will receive an email to schedule a 10-15-minute phone call with their "phone coach." The primary goal of the phone coach is to increase adherence to the self-help website (completing web-based sessions and practicing exercises therein). A secondary goal is to support acquisitioning, strengthening and generalization of concepts, exercises and skills taught in the website. However, the role of the phone coach is as a support, not a therapist. The first call will take 10-15 minutes. The goal of this brief "get to know you" phone session is to increase motivation for participating in the self-help program. By the end of the session we'd like to have participants express DARN-C (desire and reasons for, and ability and need to make changes). During this initial phone call the participant will be asked to specify times and days that they are generally available to take the follow-up coaching calls. Follow-up coaching phone calls will take place weekly (8 additional phone calls over the duration of the study) and will last 5-10 minutes. The purpose of the follow up phone calls is to keep participants motivated to use the program and to help them troubleshoot any problems that may interfere with usage. This is also an opportunity to help the participant clarify what about the program is working well for them as well as address any problems. Each participant will then 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 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.

(Treatment Group without Phone Coaching) If a participant is assigned to the treatment group without phone coaching, they will receive a comprehensive email with instructions for completing the intervention components and weekly surveys. Participants will receive weekly follow up emails and reminders as needed.

(Waitlist Control Group) Each week, for the next 8 weeks, participants will be asked to complete a short battery of questionnaires taking approximately 15 minutes. If any technical difficulties are experienced participants are encouraged to immediately contact chiaristudy@gmail.edu.

(Part 4): (Both Treatment \& Waitlist Control Groups) At the beginning of the 9th week, participants will be asked to complete a similar set of questionnaires as in Part 1 excluding the demographic questions. Since the demographic questions will not be asked again, the battery will take approximately 35-40 minutes.

(Part 5): (Both Treatment \& Waitlist Control Groups) Next, participants will again be asked to complete a 7- day sleep diary. A Qualtrics link will be emailed to participants each morning (the email will be sent out by midnight the night prior). By clicking on the link, the participants will be taken directly to the 2-5-minute survey. Participants are asked to complete this short survey (11 questions) 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 participants will be emailed a Qualtrics link to complete the same battery as in Part 4 taking about 35 - 40 minutes.

(Waitlist control group) Upon completion of the 1-month assessment, participants in 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 participants will be emailed a Qualtrics link to complete the same battery as in Part 4 and 6 taking about 35 - 40 minutes.

Eligibility criteria: 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 excluded.

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.]
measure: 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.
measure: 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.
Secondary outcomes:
measure: Change in sleep dysfunction assessed by the Sleep Diary.
timeFrame: Assessed at baseline and at the 1 week follow up after the intervention.
measure: Change in sleep dysfunction over time assessed by the Insomnia Severity Index.
timeFrame: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
measure: Change in dysfunctional beliefs and attitudes about sleep over time assessed by the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS)-16.
timeFrame: Assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.]
measure: Percentage of participants who met criteria for Minimal Clinically Important Difference (MCID) in pain scores.
timeFrame: MCID will be calculated for baseline-1 week post intervention, baseline-1 month post intervention, and baseline-3 months post intervention.]
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent state University
state: Ohio
Study officials:
affiliation: Kent State University
name: Douglas L Delahanty, PhD
role: PRINCIPAL_INVESTIGATOR
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