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Behavioral Intervention
Online Acceptance and Commitment Therapy for Chiari Malformation
N/A
Waitlist Available
Led By Douglas L Delahanty, PhD
Research Sponsored by Kent State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must report a pain intensity of at least a 3 on a scale from 1-10
Participants must have been diagnosed by a doctor with Chiari Malformation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
Awards & highlights
Study Summary
This trial studies if online Acceptance and Commitment Therapy helps reduce chronic pain in people with Chiari Malformation (CM). It will assess if phone coaching improves outcomes.
Who is the study for?
This trial is for adults diagnosed with Chiari Malformation who experience chronic pain rated at least a 3 out of 10. They must have internet access, be willing to dedicate an hour weekly for the therapy and homework over 8 weeks, and if on psychotropic meds, they should have been stable on them for the last three months.Check my eligibility
What is being tested?
The study tests online Acceptance and Commitment Therapy (ACT) with or without phone coaching against a wait-list control group to see if coaching affects adherence and outcomes in managing chronic pain associated with Chiari Malformation.See study design
What are the potential side effects?
As this is a psychological intervention rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort as they engage in therapeutic activities designed to improve their coping strategies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain level is at least a 3 out of 10.
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I have been diagnosed with Chiari Malformation.
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I can dedicate an hour a week for 8 weeks for this study.
Select...
I am 18 years old or older.
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I have been on the same mental health medication for the last 3 months.
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I have been diagnosed with Chiari Malformation.
Select...
My pain level is at least a 3 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, 8 intervention weeks, 1 week follow up, 1 month follow up, and three month follow up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in chronic pain acceptance over time assessed by the Chronic Pain Acceptance Questionnaire-Revised (CPAQ).
Change in pain intensity over time as assessed with the Numeric Rating Scale (NRS).
Change in pain interference over time assessed by the pain interference subscale of the Brief Pain Inventory.
+2 moreSecondary outcome measures
Dystocia
Change in sleep dysfunction assessed by the Sleep Diary.
Change in sleep dysfunction over time assessed by the Insomnia Severity Index.
+1 moreTrial Design
3Treatment groups
Active Control
Group I: Online Acceptance and Commitment Therapy Intervention + Phone CoachingActive Control1 Intervention
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. 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." The intervention includes 8 modules: Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). Each module ends with a practice assignment which participants are asked to engage in over the next week.
During the phone coaching calls, 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.
Group II: Waitlist ControlActive Control1 Intervention
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.
Group III: Online Acceptance and Commitment Therapy Intervention without phone coachingActive Control1 Intervention
This online Acceptance and Commitment Therapy intervention is delivered over 8 weeks, in 8 15-minute modules. 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." The intervention includes 8 modules: Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). Each module ends with a practice assignment which participants are asked to engage in over the next week.
Find a Location
Who is running the clinical trial?
Utah State UniversityOTHER
44 Previous Clinical Trials
4,299 Total Patients Enrolled
The University of AkronOTHER
9 Previous Clinical Trials
772 Total Patients Enrolled
Kent State UniversityLead Sponsor
41 Previous Clinical Trials
6,480 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't been stable on my mental health medication for the last 3 months.My pain level is at least a 3 out of 10.I have been diagnosed with Chiari Malformation.I have not been diagnosed with Chiari Malformation.I can dedicate an hour a week for 8 weeks for this study.I have been on the same mental health medication for the last 3 months.I am currently undergoing therapy or counseling.My average pain level is below 3 on a scale of 1 to 10.You cannot see or have vision problems.I am under 18 years old.I am 18 years old or older.I am currently having thoughts about harming myself.I have been on the same mental health medication for the last 3 months.People who took part in the previous ACT pilot study.You have serious mental health conditions like bipolar disorder or schizophrenia.I have not had constant pain for the last 3 months.I have been diagnosed with Chiari Malformation.My pain level is at least a 3 out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: Online Acceptance and Commitment Therapy Intervention + Phone Coaching
- Group 2: Waitlist Control
- Group 3: Online Acceptance and Commitment Therapy Intervention without phone coaching
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chiari Malformation Patient Testimony for trial: Trial Name: NCT05581472 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor still accessible to participants?
"According to clinicaltrials.gov, this particular medical trial is not currently open for recruitment. The original posting was on the first of January 2023 and the last update occured on October 12th 2022. Although no longer enrolling patients, there are still 515 other trials that are actively seeking participants right now."
Answered by AI
What prerequisites must potential participants satisfy to qualify for this medical research?
"This clinical trial seeks 72 individuals aged 18-65, with a confirmed diagnosis of Chiari Malformation and chronic pain intensity of 3 or more on the 1-10 scale. Additionally, those taking psychotropic meds must have remained stable for at least three months prior to applying. Furthermore, applicants must possess internet access as well as an hour per week over 8 weeks to dedicate towards intervention activities and homework assignments."
Answered by AI
Could individuals younger than fifty years of age be considered for participation in this study?
"Eligible candidates for this trial must range between 18 to 65 years old. There are 81 trials that cater specifically to minors whereas 437 trials focus on those of an advanced age."
Answered by AI
What objectives has this research endeavor set to achieve?
"The principal aim of this medical experiment, which will be observed over the course of baseline assessment, 8 intervention weeks, a one-week follow up period, 1 month after treatment and 3 months afterwards is to identify any change in pain intensity as quantified by the Numeric Rating Scale. Secondary objectives incorporate measuring alteration in sleep dysfunction with the Sleep Diary (a 14-item measure) and Insomnia Severity Index (7-item questionnaire), plus determining what percentage of patients achieved Minimally Clinically Important Difference (MCID). MCID represents at least 2 point decrease on 4 NRS items or 1 point reduction on Pain Interference subscale"
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Maryland
Connecticut
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2
What site did they apply to?
Kent state University
Why did patients apply to this trial?
I have Fybromyalgia and my condition is worsening. I walk with a crutch for an undiagnosed condition. I can only sleep in one position. I cannot take stronger meds, because I manage 2 Businesses and study part-time. I am in SA but willing to travel if you cover ALL expenses. I might travel to Washington DC over the next 4 months.
PatientReceived 2+ prior treatments
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