Insomnia Behavioral Intervention Study (IBI)

University of Pennsylvania

Status: Enrolling

Conditions: Chronic Insomnia

Treatments: Behavioral: Experimental: Behavioral approach 1; Behavioral: Comparator: Behavioral approach 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05301543

849022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Behavioral approach 1

Experimental group

Description:

This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.

Treatment:

Behavioral: Experimental: Behavioral approach 1

Behavioral approach 2

Active Comparator group

Description:

This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Treatment:

Behavioral: Comparator: Behavioral approach 2