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New treatment option for Insomnia
Official title Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
ClinicalTrials.gov ID: NCT07428629
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are: Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Active UC based on PRUCSI
- Insomnia Severity Index score \> 8 and SOL or WASO \> 30 minutes
- Stability of sleep \& UC meds for \> 3 months
- Access to internet or cell phone service sufficient for telehealth
You likely can't join if
- PHQ-9 depression score \> 15
- GAD-7 anxiety score \> 15
- Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
- Current alcohol or substance abuse
- Current opioid use for pain control
- Current systemic corticosteroid use
See the full eligibility criteria
- Active UC based on PRUCSI
- Insomnia Severity Index score \> 8 and SOL or WASO \> 30 minutes
- Stability of sleep \& UC meds for \> 3 months
- Access to internet or cell phone service sufficient for telehealth
- PHQ-9 depression score \> 15
- GAD-7 anxiety score \> 15
- Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
- Current alcohol or substance abuse
- Current opioid use for pain control
- Current systemic corticosteroid use
- Current pregnancy or nursing
- Ileostomy or colostomy
- Diagnosis of seizure disorder
- Diagnosis of sleep apnea
- Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
- Night shift, rotating shift work, or frequent travel outside of time zone
- Residence in a state where we cannot conduct telehealth visits
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.