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Completed

NCT Number: NCT02121652

Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute Thoracic Clinic, Buffalo, New York, United States

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About this study

A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
  • chronic insomnia

Exclusion criteria

  • Other preexisting sleep disorders
  • Unstable medical illnesses

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.

Healthy Eating Control

Behavioral

Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.

Primary outcomes

  1. Sleep Efficiency

    Time frame: 5 weeks

    Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes).

    Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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