Insomnia Behavioral Intervention Study
ConditionChronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorUniversity of Pennsylvania
About this trial
This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 55-85
Use of sleeping pill medication for sleep at least 3 nights a week
Diagnosed with Chronic Insomnia by a physician
Speaks English above a 6th-grade level
Disqualifiers
Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)
Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Behavioral approach 1
BehavioralIncludes changing sleep habits and cognitions around sleep from a mental level
Comparator: Behavioral approach 2
BehavioralIncludes changing sleep habits and awarenes of sleep from a perception level
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Behavioral approach 1Experimental treatment 1 intervention
Group B: Behavioral approach 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Pill Dosage
We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week).
Time frame
28-day follow-upSecondary outcomes
1
Sleep Efficiency
Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28).
Time frame
28-day follow-upSponsors and contacts
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Source ClinicalTrials.gov