Chronic Insomnia
Conditions
Brief summary
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.
Detailed description
This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.
Interventions
BEHAVIORALExperimental: Behavioral approach 1
Includes changing sleep habits and cognitions around sleep from a mental level
BEHAVIORALComparator: Behavioral approach 2
Includes changing sleep habits and awarenes of sleep from a perception level
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Has access to a smartphone and/or smart tablet and can use it * Has regular access to internet
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Pill Dosage | 28-day follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | 28-day follow-up | Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28). |
Countries
United States
Contacts
Primary ContactAlex J Mathew
Outcome results
None listed