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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03012425

Enrollment

Registered

2017-01-06

Start date

2017-01-03

Completion date

2020-10-23

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Related Distress Among Cancer Caregivers

Keywords

Cognitive Behavioral Therapy, Acupuncture, 17-001

Brief summary

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia (CBT-I)

PROCEDUREAcupuncture

BEHAVIORALquestionnaires

OTHERDiurnal Cortisol

saliva test

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
number of participants who complete the assessments	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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026