InsomniaNCT03012425
Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I), Acupuncture and questionnaires in people with Insomnia and Related Distress Among Cancer Caregivers, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Related Distress Among Cancer Caregivers
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Acupuncture and questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jan 2017to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Irvine
Irvine, California, 92697
Hunter College
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot 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.
- Conditions
- Insomnia, Related Distress Among Cancer Caregivers
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Acupuncture, questionnaires, Diurnal Cortisol
- Keywords
- Cognitive Behavioral Therapy, Acupuncture, 17-001
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
AcupunctureProcedure or surgery
questionnairesBehavioural
Diurnal CortisolOther
saliva test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Acupuncture; Behavioral: questionnaires; Other: Diurnal Cortisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter College of City University of New York
- Responsible party
- Sponsor
- Investigators
- Allison Applebaum, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012425
- Sponsor's protocol ID
- 17-001
- Status last verified
- Nov 2021
- First submitted
- 4 Jan 2017
- Last updated
- 8 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
- ClinicalTrials.gov ID
- NCT03012425
- Acronym / sponsor ID
- 17-001
- Conditions
- Insomnia, Related Distress Among Cancer Caregivers
- Keywords
- Cognitive Behavioral Therapy, Acupuncture, 17-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Hunter College of City University of New York
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I), Behavioral: questionnaires, Other: Diurnal CortisolSession 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. |
| Acupuncture | Experimental | Procedure: Acupuncture, Behavioral: questionnaires, Other: Diurnal CortisolSession 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Acupuncture | Procedure or surgery | Acupuncture |
| questionnaires | Behavioural | Acupuncture, Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Diurnal Cortisolsaliva test | Other | Acupuncture, Cognitive Behavioral Therapy for Insomnia (CBT-I) |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Insomnia
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Applebaum, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I), Acupuncture and questionnaires in people with Insomnia and Related Distress Among Cancer Caregivers, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who complete the assessments (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.