NCT03461666

Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

A Randomized, Open Label, Sleep Hygiene Controlled 6-Week Study to Compare the Efficacy of Four (CBT-I, FOA, Combined CBT-I and FOA and Sleep Hygiene) Different Behavioral Approaches for the Treatment of Adult Subjects With Insomnia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Pacific Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Accepted

Summary

This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I); Focus of Attention (FOA); Combined CBT-I and FOA; and Sleep Hygiene (control group) for the treatment of insomnia. This study is a randomized, open label study, and the participants are asked to assess the benefits they get from the intervention. This study involve 6 weekly in person one-to-one sessions after screening and completion of the 1-week, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administering the treatment. The Research Department will administer the outcome measures. The review of insomnia improvement will be assessed at at end of treatment, 3 months, 6 months and 12 months follow-up.

Detailed description

This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I), Focus of Attention (FOA), Combined CBT-I and FOA and Sleep Hygiene) of therapies approaches for the treatment of insomnia. This study is a randomized, open label study, the participants are asked to review the benefits they get from the intervention. This study involve 6 weekly sessions after screening and completion of the end of treatment, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administer study scales during therapy session. The subjective review of insomnia improvement will be assessed at end of treatment, 3 months, 6 months and 12 months follow-up assessment. Subjects are adult who meet, DSM-5 the diagnostic criteria for primary Insomnia. Inclusion/Exclusion criteria to be assessed at Screening (Visit 1) and Visit 2. For those found eligible who complete the study, participation will include Screening (Visit 1), 6 weekly sessions after screening, and completion of the post-treatment and 6-month followup assessment. Once subject sign the consent form, subject will be asked inclusion and exclusion criteria and will be given details about the study as per protocol. Those eligible will be randomly assigned to one of four behavioral treatment approaches. The participant will have six weekly one hour in person sessions in which the assigned treatment will be administered. The participant will be assessed at the end of treatment and again at 6 month followup.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy-Insomnia	Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
BEHAVIORAL	Focus of Attention	Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
BEHAVIORAL	Combined-CBT-I and FOA Group	Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
BEHAVIORAL	Sleep Hygiene	Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.

Timeline

• Start date: 2018-09-05
• Primary completion: 2021-11-01
• Completion: 2022-07-01
• First posted: 2018-03-12
• Last updated: 2023-04-05

Locations

2 sites across 1 country: United States