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Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

NCT03461666 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-04-05

No results posted yet for this study

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.

Conditions

  • Primary Insomnia

Interventions

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.

Sponsors & Collaborators

  • Pacific Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Max Hines, Ph.D · Puget Sound Psychiatry center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2021-11-01
Completion
2022-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461666 on ClinicalTrials.gov