Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
Public ClinicalTrials.gov record NCT04089670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04089670
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2019
- Primary completion
- Jun 29, 2020
- Completion
- Oct 29, 2020
- Last update posted
- Jan 4, 2021
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kent state University | Kent | Ohio | 44240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04089670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 4, 2021 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04089670 live on ClinicalTrials.gov.