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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: Completed NA study, sponsored by Kent State University.

NCT04089670 is a NA study that has completed, run by Kent State University. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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 va

Interventions

  • BEHAVIORAL Online Acceptance and Commitment Therapy Intervention

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2019-08-15
Est. Completion 2020-10-30
Phase NA
Kent State University

19 total trials

What the finished NCT04089670 record still lists

NCT04089670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Online Acceptance and Commitment Therapy Intervention is the first listed.

NCT04089670 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04089670's enrollment target sits among peer trials

52 1272nd of 2000 higher than 722 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04089670, the US trial registry maintained by the National Library of Medicine. NCT04089670 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.