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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia for Sleep Disorder (SPIN Trial)

N/A
Waitlist Available
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Insomnia severity index score of 8 or greater
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline assessment to 1-month post intervention
Awards & highlights

SPIN Trial Summary

This trial will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat sleep problems in people with Crohn's disease, in order to see if it also improves other symptoms like pain and inflammation.

Eligible Conditions
  • Sleep Disorder
  • Crohn's Disease
  • Pain
  • Inflammation
  • Insomnia

SPIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have trouble sleeping and your score on a sleep test is 8 or higher.

SPIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline assessment to 1-month post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline assessment to 1-month post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in diary-based sleep onset latency
Change in diary-based wake after sleep onset
Change in insomnia symptoms as measured by the Insomnia Severity Index
Secondary outcome measures
Change in C-reactive protein
Change in behaviorally assessed pain tolerance via the Cold Pressor Test
Change in diary sleep efficiency based on ambulatory EEG monitoring
+10 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

SPIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. Five CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
Group II: WaitlistActive Control1 Intervention
No intervention for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
521 Previous Clinical Trials
2,542,371 Total Patients Enrolled
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
28,097 Total Patients Enrolled
Crohn's & Colitis FoundationUNKNOWN
3 Previous Clinical Trials
1,073 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 main objectives of this research?

"The primary outcome of this clinical trial will be measured over a period of one month, and is defined as the change in diary-based wake after sleep onset. Secondary objectives include change in time spent in slow wave sleep (as measured by percentage of time spent in slow wave sleep during a night's sleep), change in fecal calprotectin (as measured by levels of fecal calprotectin via a stool sample), and change in sleep onset latency as measured by actigraphy."

Answered by AI

Are we currently recruiting for this research project?

"While no longer recruiting patients, this clinical trial was posted on October 22nd 2021 and last updated 17th October 2022. However, there are still 1261 other trials that currently need participants."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Maryland
How old are they?
65+
What site did they apply to?
Dartmouth-Hitchcock Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~8 spots leftby Mar 2025