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Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation

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ClinicalTrials.gov Identifier: NCT04089670
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
Utah State University
Conquer Chiari
Information provided by (Responsible Party):
Douglas L. Delahanty, Kent State University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Chiari Malformation Behavioral: Online Acceptance and Commitment Therapy Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
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
Official Title: Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Online Acceptance and Commitment Therapy Intervention
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. Each module has a practice assignment at the end with the goal of having the participant engage in the material over the next week. 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." 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.
Behavioral: Online Acceptance and Commitment Therapy Intervention
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Change in pain interference assessed by the Brief Pain Inventory Short-form over time [ Time Frame: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention ]
    This 9-item inventory assesses pain severity and pain interference over the past 24 hours. "Worst," "least," "average," and "current" pain severity are assessed. Pain interference items are measured on a scale from 0 - 10 (0 = Does not interfere, 10 = Completely interferes) and assesses the degree of pain interference in seven daily activities including general activity, walking, work, mood, enjoyment of life, relationships with others, and sleep. Prior research has demonstrated good internal validity and reliability in chronic pain samples.

  2. Change in psychological flexibility assessed by the Acceptance and Action Questionnaire II over time [ Time Frame: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention ]
    This 7-item inventory is measured on a Likert scale (1 = never true, 7 = always true) and is the most commonly utilized measure of experiential avoidance and psychological flexibility. There is no specified time domain that this questionnaire evaluates. This measure assesses negative evaluations of emotions, avoidance of difficult thoughts and emotions, and behavioral modifications while in the context of challenging thoughts or feelings and has demonstrated good validity, and test re-test reliability

  3. Change in sleep dysfunction assessed by the Insomnia Severity Index over time [ Time Frame: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention ]
    This 7-item index is used to capture perception of nocturnal and diurnal symptoms of insomnia over the past week. It specifically examines difficulties initiating sleep, maintaining sleep, and waking up too early, as well as satisfaction with current sleep, the perceived impact poor sleep has on quality of life and daily functioning, and distress related with sleep difficulties.

  4. Change in sleep dysfunction assessed by the Daily Sleep Diary over time [ Time Frame: Assessed for 7 days prior to the intervention and for 7 days following the intervention. ]
    This 12-question daily sleep diary assesses sleep duration, efficiency, and quality over the past night, these questions were used in a previous study (Tang, Goodchild, Sanborn, Howard, & Salkovskis, 2012). Questions include bedtime, rise time, how long it took to fall asleep, number of wake times (disrupted sleep maintenance), and length of time asleep. Additionally, a rating of quality of sleep (0 = very poor, 10 = very good), cognitive arousal (i.e., racing thoughts prior to bed), somatic arousal (i.e., feeling restless or jittery prior to bed), level of current pain (0 = no pain at all, 10 = a lot of pain), predicted amount of pain over the next day (0 = no pain at all, 10 = a lot of pain), and mood (0 = very bad mood, 10 = very good mood) is assessed.

  5. Change in depression and anxiety assessed by the Depression Anxiety and Stress Scale-21 over time [ Time Frame: Assessed at baseline and weekly for 8-weeks, also assessed at the beginning of week 9, and 1-month and 3-months after the completion of the intervention ]
    This 21-item measure that assesses depression, anxiety, and stress levels over the past week (Lovibond, Lovibond, & Australia, 1995). Internal consistencies for depression, anxiety, and stress in prior research has been good (Taylor, Lovibond, Nicholas, Cayley, & Wilson, 2005). In chronic pain samples the scale has demonstrated good internal consistency at the group level (Parkitny et al., 2012). Additionally, this measure does not include somatic symptoms in the depression scale, which prevents the depression score from being artificially inflated based on pain symptoms.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fluent in English
  • Chiari Malformation
  • Access to the internet
  • Be willing to commit approximately an hour a week for 8 weeks to engage in the intervention and homework
  • Experience persistent pain for a minimum of 3-months
  • Rate their pain intensity as greater than a 3 on a scale from 1-10
  • Be stable on psychotropic medication for the past 3 months (if taking psychotropic medication)

Exclusion Criteria:

  • Blindness
  • Currently receiving Acceptance or Commitment Therapy or Cognitive Behavioral Therapy
  • Have active suicidal ideations
  • Diagnosed with a severe psychiatric disorder including bipolar disorder and schizophrenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089670


Contacts
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Contact: Douglas L Delahanty, PhD. 300.672.5322 ddelahan@kent.edu
Contact: Monica A Garcia, MA (330) 672-5322 mgarci14@kent.edu

Locations
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United States, Ohio
Kent state University Recruiting
Kent, Ohio, United States, 44240
Contact: Douglas L Delahanty, PhD    300-672-2395    ddelahan@kent.edu   
Sponsors and Collaborators
Kent State University
Utah State University
Conquer Chiari
Investigators
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Principal Investigator: Douglas L Delahanty, PhD. Kent State University

Publications:
Cleeland, D. C. S. (2005). The Brief Pain Inventory- Short Form. 38.
Gaskin, D. J., & Richard, P. (2011). The Economic Costs of Pain in the United States. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK92521/
Lovibond, S. H., Lovibond, P. F., & Australia, P. F. of. (1995). Manual for the depression anxiety stress scales. Retrieved from http://trove.nla.gov.au/version/46688692

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Responsible Party: Douglas L. Delahanty, Professor and Associate Vice President of Research, Kent State University
ClinicalTrials.gov Identifier: NCT04089670     History of Changes
Other Study ID Numbers: 19-171
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Douglas L. Delahanty, Kent State University:
Chronic Pain
Acceptance and Commitment Therapy
Sleep Dysfunction
Online Intervention
Additional relevant MeSH terms:
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Arnold-Chiari Malformation
Congenital Abnormalities
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases