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

NCT03012425 | Completed

• 1 other identifier: 17-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Insomnia; Related Distress Among Cancer Caregivers

Keywords

Cognitive Behavioral Therapy; Acupuncture; 17-001

Outcome Measures

Primary Outcomes (1)

• number of participants who complete the assessments

  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)

  1 year

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia (CBT-I)

EXPERIMENTAL

Session 1- Review of initial sleep diary, formulation of impression of type/subtype of insomnia, determine modifiable factors, address immediate concerns about participation, discuss motivation \& compliance. Session 2- Review of sleep diary, present 4-P model of insomnia, prescribe Sleep Restriction \& Stimulus Control Therapy. Session 3- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, review of sleep hygiene. Session 4- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, introduce \& practice relaxation strategies. Session 5- Review of sleep diary, continue with stimulus control \& sleep restriction procedures, conduct cognitive therapy to address dysfunctional thoughts underlying insomnia. Session 6- Review of sleep diary, continue with stimulus control \& sleep restriction procedures Session 7- Review of sleep diary \& overall progress, discuss relapse prevention, further sleep restriction guidelines \& prophylaxis.

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Behavioral: questionnaires; Other: Diurnal Cortisol

Acupuncture

EXPERIMENTAL

Session 1 - Detailed history and examination, introduction to acupuncture. Sessions 2 - 10 - Each session will begin with insertion and manipulation of needles, which will remain in place for 30 minutes.

Procedure: Acupuncture; Behavioral: questionnaires; Other: Diurnal Cortisol

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Acupuncture PROCEDURE

Acupuncture

questionnaires BEHAVIORAL

Acupuncture; Cognitive Behavioral Therapy for Insomnia (CBT-I)

Diurnal Cortisol OTHER

saliva test

Acupuncture; Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Hunter College of City University of New York: collaborator

Study Sites (3)

University of California, Irvine

Irvine, California, 92697, United States

Location

Hunter College

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Acupuncture Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Complementary Therapies; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Allison Applebaum, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: January 3, 2017
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

US (3)