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Behavioral Intervention
Acceptance and Commitment Therapy for NMOSD
N/A
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months prior to baseline to baseline, baseline to 3 months post-treatment
Awards & highlights
Study Summary
This trial will test if Acceptance and Commitment Therapy can reduce anxiety/depression in those with NMOSD and their caregivers, and improve overall health.
Who is the study for?
This trial is for adults over 18 with Neuromyelitis Optica Spectrum Disorder (NMOSD) and their caregivers. Participants must show signs of anxiety or depression, indicated by a score greater than 4 on specific mental health questionnaires, and have access to a webcam.Check my eligibility
What is being tested?
The study tests Acceptance and Commitment Therapy (ACT), which is designed to help reduce anxiety and depression in NMOSD patients and their caregivers, aiming to improve overall health outcomes.See study design
What are the potential side effects?
Since ACT is a type of psychotherapy involving talking and behavior strategies rather than medication, it typically does not have physical side effects but may bring up emotional discomfort temporarily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months prior to baseline to baseline, baseline to 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months prior to baseline to baseline, baseline to 3 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Beck Anxiety Inventory (BAI)
Changes in Beck Depression Inventory (BDI-II)
Changes in Generalized Anxiety Disorder Questionnaire (GAD7)
+1 moreSecondary outcome measures
Acceptance and Action Questionnaire
Brief Fatigue Inventory
Cognitive Fusion Questionnaire - 13 item version
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Acceptance and Commitment TherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Find a Location
Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Industry Sponsor
253 Previous Clinical Trials
41,155 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,389 Total Patients Enrolled
AlexionIndustry Sponsor
246 Previous Clinical Trials
39,230 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of this investigation in terms of participants?
"Affirmative. Clinicaltrials.gov's information suggests that this research is recruiting patients, which was first publicised on June 1st 2023 and last modified on November 20th of the same year. 50 individuals are being accepted at a single site."
Answered by AI
Is there still room for participants in this clinical study?
"Affirmative, clinicaltrials.gov provides evidence that this research is currently seeking volunteers for participation. It was posted on June 1st 2023 and modified as recently as November 20th of the same year. There are 50 positions available across a single trial site."
Answered by AI
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