InsomniadBTSNCT04308499
Digital Behavioral Therapy for Sleep Problems
A study testing Digital cognitive-behavioral therapy for insomnia (dCBTI) and Sleep hygiene education (SHE) in people with Insomnia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Insomnia
- What is being tested?
- Digital cognitive-behavioral therapy for insomnia (dCBTI) and Sleep hygiene education (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 Feb 2024
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of insomnia disorder
- Aged 18 years or older
- Reliable Internet access using either computer or smartphone
- Ability to read and understand English
Who cannot join
- High risk of obstructive sleep apnea
- Diagnosis of restless legs syndrome
- Severe health issues requiring hospital admission
- Currently receiving psychological treatment for insomnia
- Reporting current suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, 90095
About this study
Official title: Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.
- Conditions
- Insomnia
- Being tested
- Digital cognitive-behavioral therapy for insomnia (dCBTI), Sleep hygiene education (SHE)
- 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.
Digital cognitive-behavioral therapy for insomnia (dCBTI)Behavioural
Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone
Sleep hygiene education (SHE)Behavioural
Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet
| Study group | Role | What they receive |
|---|---|---|
| Digital cognitive-behavioral therapy for insomnia (dCBTI) | Experimental | Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions Receives: Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI) |
| Sleep hygiene education (SHE) | Active comparator | Recognized and commonly prescribed set of sleep hygiene instructions Receives: Behavioral: Sleep hygiene education (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Measured: Weeks 0, 4, 8, and 24
Change in Sleep Efficiency
Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)
Measured: Weeks 0, 4, 8, and 24
Secondary outcomes (8)
Change in Total Sleep Time (TST)
Change in sleep duration
Measured: Weeks 0, 4, 8, and 24
Change in Epworth Sleepiness Scale (ESS)
Change in daytime sleepiness assessed by a scale with higher scores indicating worse outcome (range 0-24)
Measured: Weeks 0, 4, 8, and 24
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Change in depressive symptoms assessed by a scale with higher scores indicating worse outcome (range 0-60)
Measured: Weeks 0, 4, 8, and 24
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Change in anxiety symptoms assessed by a scale with higher scores indicating worse outcome (range 0-21)
Measured: Weeks 0, 4, 8, and 24
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Change in anhedonia assessed by a scale with higher scores indicating worse outcome (range 0-14)
Measured: Weeks 0, 4, 8, and 24
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Change in fatigue assessed by a scale with higher scores indicating worse outcome (range 0-120)
Measured: Weeks 0, 4, 8, and 24
Change in UCLA Loneliness Scale (ULS)
Change in loneliness assessed by a scale with higher scores indicating worse outcome (range 20-80)
Measured: Weeks 0, 4, 8, and 24
Change in Insomnia Caseness
Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI)
Measured: Weeks 0, 4, 8, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Mar 2020
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Why it stopped: Difficulty to recruit HIV patients with insomnia
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 University of California, Los AngelesThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Hyong-Jin Cho, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308499
- Sponsor's protocol ID
- 19-000064
- Acronym
- dBTS
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2020
- Last updated
- 1 May 2024
- Results posted
- No
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT04308499
- Acronym / sponsor ID
- dBTS / 19-000064
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit HIV patients with insomnia
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 16 Mar 2020 (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.
Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital cognitive-behavioral therapy for insomnia (dCBTI) | Experimental | Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI)Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions |
| Sleep hygiene education (SHE) | Active comparator | Behavioral: Sleep hygiene education (SHE)Recognized and commonly prescribed set of sleep hygiene instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-5 diagnosis of insomnia disorder
- Aged 18 years or older
- Reliable Internet access using either computer or smartphone
- Ability to read and understand English
Key exclusion criteria (5 listed)
- High risk of obstructive sleep apnea
- Diagnosis of restless legs syndrome
- Severe health issues requiring hospital admission
- Currently receiving psychological treatment for insomnia
- Reporting current suicidal ideation
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 |
|---|---|---|
| Digital cognitive-behavioral therapy for insomnia (dCBTI)Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone | Behavioural | Digital cognitive-behavioral therapy for insomnia (dCBTI) |
| Sleep hygiene education (SHE)Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet | Behavioural | Sleep hygiene education (SHE) |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: Weeks 0, 4, 8, and 24
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Change in Sleep Efficiency
Time frame: Weeks 0, 4, 8, and 24
Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)
8 secondary outcomes
Change in Total Sleep Time (TST)
Time frame: Weeks 0, 4, 8, and 24
Change in Epworth Sleepiness Scale (ESS)
Time frame: Weeks 0, 4, 8, and 24
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Weeks 0, 4, 8, and 24
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Weeks 0, 4, 8, and 24
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Weeks 0, 4, 8, and 24
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Time frame: Weeks 0, 4, 8, and 24
Change in UCLA Loneliness Scale (ULS)
Time frame: Weeks 0, 4, 8, and 24
Change in Insomnia Caseness
Time frame: Weeks 0, 4, 8, and 24
Results and safety
The study was stopped early (reason given: Difficulty to recruit HIV patients with insomnia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive-behavioral therapy for insomnia (dCBTI) and Sleep hygiene education (SHE) in people with Insomnia, run by University of California, Los Angeles 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 May 2024. 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?
The study was stopped early (reason given: Difficulty to recruit HIV patients with insomnia). Results are not available in the source record.
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?
Change in Insomnia Severity Index (ISI) (time frame: Weeks 0, 4, 8, and 24). The study lists 2 primary outcomes in all. 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 1 May 2024.