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Behavioral Intervention
Mindfulness-Based Therapy for Insomnia (RESIST Trial)
N/A
Recruiting
Led By Christopher L Drake, PhD
Research Sponsored by Henry Ford Health System
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 10 weeks after screening
Awards & highlights
RESIST Trial Summary
This trial will test whether a mindfulness-based therapy can help reduce symptoms of insomnia in people who haven't responded to other treatments.
Who is the study for?
This trial is for adults who have insomnia with a score of over 10 on the Insomnia Severity Index (ISI) and haven't found relief from previous treatments like cognitive behavioral therapy or medications. It's not open to those under 18, people taking antidepressants for depression, or individuals with bipolar disorder, seizure disorders, or other known sleep disorders besides insomnia.Check my eligibility
What is being tested?
The study is examining if Mindfulness-Based Therapy for Insomnia (MBTI) can help reduce symptoms of insomnia and mental restlessness in patients whose condition hasn't improved after trying other therapies.See study design
What are the potential side effects?
Mindfulness-based interventions are generally considered safe but may include temporary increases in anxiety, distress or discomfort when learning new coping skills.
RESIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks after screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks after screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severity of Insomnia Symptoms - 6-month Post Treatment
Severity of Insomnia Symptoms - Acute Post Treatment
Secondary outcome measures
Effects on Cognitive Emotional Arousal-Nocturnal Rumination - 6-month Post Treatment
Effects on Cognitive Emotional Arousal-Nocturnal Rumination - Acute Post Treatment
Effects on depression - 6 months Posttreatment
+1 moreRESIST Trial Design
1Treatment groups
Experimental Treatment
Group I: MBTIExperimental Treatment1 Intervention
Mindfulness-Based Therapy for Insomnia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Therapy for Insomnia
2008
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,717 Total Patients Enrolled
9 Trials studying Insomnia
1,193 Patients Enrolled for Insomnia
Christopher L Drake, PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
1,237 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with insomnia, as measured by a score higher than 10 on the Insomnia Severity Index.I am under 18 years old.I am currently taking antidepressants for depression.You have been diagnosed with insomnia, with a score of more than 10 on the Insomnia Severity Index.I have a sleep disorder other than insomnia.I have a history of bipolar disorder or seizures.My insomnia didn't improve with therapy or medication.My insomnia didn't improve with therapy or medication.My insomnia didn't improve after therapy or medication.
Research Study Groups:
This trial has the following groups:- Group 1: MBTI
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people with the condition are being given the chance to participate in this research?
"Yes, an update on the clinicaltrials.gov website shows that this study is actively recruiting patients. The trial was created on September 1st, 2020 and the most recent update was on May 17th, 2022. The study needs 30 more patients from 1 location."
Answered by AI
Are new participants being registered for this experiment?
"That is accurate, the information on clinicaltrials.gov does say that this study is currently looking for participants. The listing was created on September 1st 2020 and was last updated on May 17th 2022. The study only needs 30 patients but is only looking at one site."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
Henry Ford Health System - Columbus
What portion of applicants met pre-screening criteria?
Met criteria
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