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NCT04089670 · ClinicalTrials.gov registry record · NA
Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
A NA study, sponsored by Kent State University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT04089670 is a NA study that has completed, run by Kent State University. The registered enrollment target is 52 participants.
The verdict
NCT04089670, a NA study, has completed, sponsored by Kent State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Online Acceptance and Commitment Therapy Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2020-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04089670
The ClinicalTrials.gov registry entry for NCT04089670 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kent State University, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Online Acceptance and Commitment Therapy Intervention is the first listed.
NCT04089670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04089670 about?
NCT04089670 is a clinical study titled "Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation". 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 associa...
What is the current status of trial NCT04089670?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2019-08-15. Estimated completion is 2020-10-30.
What interventions are being tested in trial NCT04089670?
The interventions under investigation include: Online Acceptance and Commitment Therapy Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04089670?
This trial is sponsored by Kent State University, which has 19 total clinical trials registered on ClinicalTrials.gov.
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