InsomniaNCT01804907
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
A study testing Cognitive Behavioral Therapy and Behavioral Modification in people with Insomnia and Sleep Efficiency, run by Duke University at 1 site in United States.
Trial summary
To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia, Sleep Efficiency
- What is being tested?
- Cognitive Behavioral Therapy and Behavioral Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study;
- males or females age 18-75 years of age;
- ≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD;
- sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary);
- be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period.
Who cannot join
- use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics;
- history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
- clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
- self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1);
- have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study;
- unable to give informed consent or comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.
- Conditions
- Insomnia, Sleep Efficiency
- Being tested
- Cognitive Behavioral Therapy, Behavioral Modification
- Keywords
- HAART adherence, HIV, Fatigue, treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Behavioral ModificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Behavioral Modification | Sham comparator | Standard sleep hygiene education/desensitization therapy Receives: Behavioral: Behavioral Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Patients evaluated weekly for change in sleep efficiency.
Measured: Week 1, 2,3, and 4
Secondary outcomes (2)
Adherence to HAART
Evaluated once weekly for changes in medication adherence.
Measured: Week 1, 2,3, and 4
Fatigue
Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).
Measured: Week 1, 2,3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Duke UniversityThe 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
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804907
- Sponsor's protocol ID
- Pro00032846
- Status last verified
- Apr 2015
- First submitted
- 4 Mar 2013
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
- ClinicalTrials.gov ID
- NCT01804907
- Acronym / sponsor ID
- Pro00032846
- Conditions
- Insomnia, Sleep Efficiency
- Keywords
- HAART adherence, HIV, Fatigue, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Mar 2013 (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.
To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
| Behavioral Modification | Sham comparator | Behavioral: Behavioral ModificationStandard sleep hygiene education/desensitization therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study;
- males or females age 18-75 years of age;
- ≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD;
- sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary);
- be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period.
Key exclusion criteria (6 listed)
- use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics;
- history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
- clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
- self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1);
- have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study;
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 | Behavioural | CBT |
| Behavioral Modification | Behavioural | Behavioral Modification |
Primary outcome
Sleep Efficiency
Time frame: Week 1, 2,3, and 4
Patients evaluated weekly for change in sleep efficiency.
2 secondary outcomes
Adherence to HAART
Time frame: Week 1, 2,3, and 4
Fatigue
Time frame: Week 1, 2,3, and 4
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 20 Apr 2015.
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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 Cognitive Behavioral Therapy and Behavioral Modification in people with Insomnia and Sleep Efficiency, run by Duke University 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 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 20 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
Sleep Efficiency (time frame: Week 1, 2,3, and 4). 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 20 Apr 2015.