Health TrialsbyHealthPanel

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

ConditionsInsomniaUlcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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? * Does CBT-I for UC impact insomnia severity and sleep continuity?

Participants will:

* Answer questionnaires online before and after treatment * Complete an online daily sleep diary before, during, and after treatment * Participate in 5 telehealth treatment visits over 7-8 weeks * Participate in 5-10-minute phone calls between treatment visits

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CBT-I UC

    Behavioral

    This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CBT-I UC TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention

Measured based on the percentage of participants who complete the full study.

Time frame
Baseline, 8 weeks
2

Recruitment rate

Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.

Time frame
From study initiation until we are no longer actively recruiting (approximately 3 months)
3

Acceptability

Visit completion will be based the number of visits (out of 5) completed by each participant.

Time frame
8 weeks
4

Treatment acceptability questionnaire score

The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.

Time frame
1 week

Secondary outcomes

1

Change in insomnia symptoms as measured by the Insomnia Severity Index

The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.

Time frame
Baseline, 8 weeks
2

Change in diary-based sleep onset latency

A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary

Time frame
Baseline, 8 weeks
3

Change in diary-based wake after sleep onset

A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary

Time frame
Baseline, 8 weeks
4

Change in diary-based sleep efficiency

Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.

Time frame
Baseline, 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov
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