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Completed

NCT Number: NCT03012425

Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers

The other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of cancer patients.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Related Distress Among Cancer Caregivers Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • As per self report, age 18 and older
  • As per self report, identifying as an informal caregiver to MSKCC patients of any site or stage of cancer
  • Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule
  • In the judgment of the investigators and/or consenting professional, able to read and comprehend English
  • In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion criteria

  • As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without CPAP treatment)
  • As per self report, participant has major depressive disorder, alcohol or drug dependence and
  • As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week)
  • As per self report, engaging in night shift work
  • To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded.
  • As per self report significant needle phobia as to prevent participation in acupuncture

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

Acupuncture

Procedure

Questionnaires

Behavioral

Diurnal Cortisol

Other

saliva test

Primary outcomes

  1. number of participants who complete the assessments

    Time frame: 1 year

    treatment tolerability (rate of CBT-I and acupuncture completion, defined as completing at least 4 out of 7 sessions of CBT-I and 8 out of 10 sessions of acupuncture)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Hunter College of City University of New York

Registry information

Official study title

Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2017
Registry last updated
Nov 8, 2021

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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