Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
CompletedNot applicableNCT04089670
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Online Acceptance and Commitment Therapy for Chronic Pain in Sample of People With Chiari Malformation
- Conditions
- Chronic Pain
- Chiari Malformation
- Interventions
- Behavioral: Online Acceptance and Commitment Therapy Intervention
- Sponsor
- Kent State University
- Collaborators
- Utah State University; Conquer Chiari
- Start date
- 2019-08-15
- Primary completion
- 2020-06-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04089670