CBTi for the Treatment of Insomnia in Type 1 Diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Illinois at Chicago
About this trial
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
* meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
* receive weekly health education emails * receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
* monitor their sleep for 2 weeks through a sleep-monitoring watch * share their continuous glucose monitoring data throughout the study * answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention * attend 3 in person office visits
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 18 to 65 years old
Have been diagnosed with Type 1 Diabetes for at least a year
Use a continuous glucose monitor
Have poor sleep quality
Disqualifiers
Currently or planning pregnancy or breast feeding
Employed with a rotating or night shift
Are at a high risk for obstructive sleep apnea
Non-English speaking (unable to participate in therapy or questionnaire).
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep quality improvement therapy
Behavioral8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study.
Healthy Living
BehavioralHealth education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral Therapy Intervention for InsomniaExperimental treatment 1 intervention
Group B: Healthy LivingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability
Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
Time frame
From enrollment to the end of the intervention (12 weeks)Secondary outcomes
1
Glycemic Variability
Assessed as time in, above or below range as collected by the continuous glucose monitor.
Time frame
Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)2
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a questionnaire that assesses sleep quality and disturbances within the last month. It consists of 18 questions that either have scaled questions with four options or asks the participant for input regarding factors like bed time, time to fall asleep, hours of sleep etc. Each participant answer, both on the scale and on input, is assigned a score between 0 and 3. Thus, the score range goes from 0 to 54, with a higher score indicating worse sleep quality.
Time frame
Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)3
Glycemic Control
Assessed through A1C
Time frame
Week 0 (baseline) and Week 12 (end of treatment)4
Sleep duration
Measured by actigraphy watch
Time frame
Week 0 (baseline) and Week 12 (end of treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov