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Behavioural Intervention

Cognitive Behavioral Therapy for Insomnia

N/A

Recruiting

Led By Sarah Emert

Research Sponsored by Idaho State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Must not have

Inability to attend weekly therapy sessions either in-person or via telehealth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1-6 of treatment, week 8, 1 month follow up

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on cognitive functioning and the progression of cognitive decline. Insomnia is a common sleep disorder that can lead to various

Who is the study for?

This trial is for adults with insomnia disorder, aiming to improve their sleep and cognitive functioning. Participants should have a diagnosis of insomnia and be interested in non-medication therapy. Those currently on sedatives or with inconsistent treatment histories may not qualify.

What is being tested?

The study tests modified Cognitive Behavioral Therapy for Insomnia (CBTi), which includes techniques like stimulus control, sleep restriction, and sleep compression. It's designed to see if these methods can help people sleep better without medication and potentially protect against cognitive decline.

What are the potential side effects?

Since CBTi is a behavioral therapy rather than a drug, it doesn't have physical side effects like medications do. However, participants might experience temporary discomfort due to changes in their sleeping habits as they adjust to the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot attend weekly therapy sessions, neither in-person nor online.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1-6 of treatment, week 8, 1 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1-6 of treatment, week 8, 1 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1-6 of treatment, week 8, 1 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity

Multidimensional Sleep Health

Sleep Efficiency

Secondary study objectives

Cognitive Functioning

Other study objectives

Improvements in Objective Sleep

Improvements in Subjective Sleep

Treatment Adherence and Attendance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Waitlist ControlActive Control1 Intervention

Waitlist Control. Those randomly assigned to the WLC group will be told that they must wait 4 weeks for treatment, which is a fraction of the typical wait period in routine clinical care. During this time the participants are asked to maintain their regular schedule. At the end of 4 weeks, they will complete the baseline assessments again, which will serve as the post-waitlist assessment and then scheduled with a clinician to receive CBTi.

Group II: Stimulus ControlActive Control1 Intervention

Stimulus control.45 People with insomnia may fail to associate the bedroom with sleep, and instead may associate it with worrying, planning, or recreation. Stimulus control includes the following instructions: (1) go to bed only when sleepy; (2) only use your bed or bedroom for sleep (or sex); (3) if you do not fall asleep quickly (i.e., 15 minutes), leave the bed, do something in another room, and return to bed only when you feel a strong sleep urge; (4) if you do not fall asleep quickly upon returning to bed, repeat instruction 3; (5) use your alarm to awaken at the same time every morning regardless of duration of sleep obtained; and (6) do not take long naps.

Group III: Sleep RestrictionActive Control1 Intervention

Sleep restriction.46 People with insomnia often spend too much time awake in bed. Sleep restriction modifies the participant's sleep window so total time in bed is no more than 30 minutes beyond their average total sleep time to consolidate sleep, thus improving depth, continuity, and consistency. As the participant's sleep efficiency improves with treatment (i.e., the percentage of total time spent asleep within the sleep window), their sleep window is also increased. However, the shortened sleep window often causes increased anxiety.

Group IV: Sleep CompressionActive Control1 Intervention

Sleep compression.47,48 Sleep compression encourages time-in-bed restrictions. Unlike sleep restriction, sleep compression allows a gradual reduction in time-in-bed over the course of multiple weeks. Typically, average total sleep time and total time in bed values are calculated from one or more weeks of daily sleep diaries. The difference between these two values is then divided by the number of weeks remaining and the allotted time in bed duration is compressed by this calculated value weekly, by delaying bedtime or advancing wake time.

0 / 2Eligibility criteria met