InsomniaNCT05759065
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
A study testing Tele-Brief Behavioral Treatment for Insomnia and Tele-Cognitive-Behavioral Therapy for Insomnia in people with Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Tele-Brief Behavioral Treatment for Insomnia and Tele-Cognitive-Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Meet clinical diagnostic criteria for insomnia (DSM-V criteria)
- Insomnia severity score > 10
- Eligible to receive care through publicly-supported medical assistance (e.g. Commonwealth Connector plan; MassHealth. For participants >65 years old on Medicare, they will be asked about insurance coverage prior to initiating Medicare, OR
- Identify as racial or ethnic minority
- Has capacity for informed consent (SDT<9)
Who cannot join
- Untreated, current major depressive disorder (PHQ-8≥ 20)
- History of bipolar disorder or psychosis
- Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
- Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
- Seizure within the past 1 year
- Main sleep period outside of 8pm - 11am
Show all 12Show fewer
- Regular nightshift work (5 overnight shifts/month, defined as working between midnight-5am)
- Untreated, previously diagnosed moderate to severe sleep apnea
- Severe medical condition, which may require hospitalizations over the next 6 months
- Active suicidal ideation, if elicited passively during screening
- Pregnant or planning to become pregnant (self-reported)
- Participation in other studies that may impact the benefit or safety of the intervention, as determined by the study PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Carolina Dos Santos, 617-278-0746
About this study
The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.
- Conditions
- Insomnia
- Being tested
- Tele-Brief Behavioral Treatment for Insomnia, Tele-Cognitive-Behavioral Therapy for Insomnia
- 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.
Tele-Brief Behavioral Treatment for InsomniaBehavioural
Brief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep.
Tele-Cognitive-Behavioral Therapy for InsomniaBehavioural
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Brief Behavioral Treatment for Insomnia | Experimental | Not described Receives: Behavioral: Tele-Brief Behavioral Treatment for Insomnia |
| Tele-Cognitive-Behavioral Therapy for Insomnia | Active comparator | Not described Receives: Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index, ISI
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: 3 months
Secondary outcomes (10)
Insomnia severity index, ISI
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: 6- and 12-months
Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
The PROMIS Global Health measures assess an individual's physical, mental and social health. The measure produces two scores: Physical and Mental Health from 4 items each. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: 3-months
Quality of Life and Symptoms - Generic-quality of life
Generic-quality of life will be assessed by the change in the Euroqol - 5 Dimensions (EQ-5D) questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. There is no total score or range.
Measured: 3-months
Generalized Anxiety Disorder (GAD-7)
GAD-7 measures self-reported anxiety disorder. The measure includes 7-items with higher scores indicating anxiety. The minimum score is 0 and the maximum score is 21.
Measured: 3-months
Patient Health Questionnaire for depression (PHQ-8)
PHQ-8 measures self-reported current depression. The measure includes 8-items with higher scores indicating depression. The minimum score is 0 and the maximum score is 24.
Measured: 3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a
PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: 3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: 3-months
Diary reported sleep duration
Self-reported sleep duration with be measured using sleep diary
Measured: 3-months
Diary-reported sleep efficiency
Self-reported sleep efficiency with be measured using sleep diary
Measured: 3-months
Number of participants with hypnotic use self-reported from the sleep diary
Hypnotic use will be measured by the number of participants who self-reported use on the sleep diary
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start2 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 Brigham and Women's HospitalThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759065
- Sponsor's protocol ID
- 2023P000106
- Status last verified
- May 2026
- First submitted
- 8 Feb 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
- ClinicalTrials.gov ID
- NCT05759065
- Acronym / sponsor ID
- 2023P000106
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Mar 2023 (actual)
- 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 overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Brief Behavioral Treatment for Insomnia | Experimental | Behavioral: Tele-Brief Behavioral Treatment for Insomnia |
| Tele-Cognitive-Behavioral Therapy for Insomnia | Active comparator | Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Meet clinical diagnostic criteria for insomnia (DSM-V criteria)
- Insomnia severity score > 10
- Eligible to receive care through publicly-supported medical assistance (e.g. Commonwealth Connector plan; MassHealth. For participants >65 years old on Medicare, they will be asked about insurance coverage prior to initiating Medicare, OR
- Identify as racial or ethnic minority
Key exclusion criteria (12 listed)
- Untreated, current major depressive disorder (PHQ-8≥ 20)
- History of bipolar disorder or psychosis
- Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
- Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
- Seizure within the past 1 year
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 |
|---|---|---|
| Tele-Brief Behavioral Treatment for InsomniaBrief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep. | Behavioural | Tele-Brief Behavioral Treatment for Insomnia |
| Tele-Cognitive-Behavioral Therapy for InsomniaCognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks. | Behavioural | Tele-Cognitive-Behavioral Therapy for Insomnia |
Primary outcome
Insomnia severity index, ISI
Time frame: 3 months
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
10 secondary outcomes
Insomnia severity index, ISI
Time frame: 6- and 12-months
Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Time frame: 3-months
Quality of Life and Symptoms - Generic-quality of life
Time frame: 3-months
Generalized Anxiety Disorder (GAD-7)
Time frame: 3-months
Patient Health Questionnaire for depression (PHQ-8)
Time frame: 3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a
Time frame: 3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
Time frame: 3-months
Diary reported sleep duration
Time frame: 3-months
Diary-reported sleep efficiency
Time frame: 3-months
Number of participants with hypnotic use self-reported from the sleep diary
Time frame: 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Brief Behavioral Treatment for Insomnia and Tele-Cognitive-Behavioral Therapy for Insomnia in people with Insomnia, run by Brigham and Women's Hospital at 1 site 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Bertisch, MD, MPH (857-307-0355, sbertisch@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index, ISI (time frame: 3 months). 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 7 May 2026.