InsomniaNCT02259101
RCT of CBT for Insomnia With PLWHA
A study testing CBT-I Treatment Condition and SH Comparison Condition in people with Insomnia and HIV, run by Emory University at 1 site in United States.
Trial summary
The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CBT-I Treatment Condition and SH Comparison Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking individuals
- over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
- study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
- must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
- the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
- sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)
Who cannot join
- current substance dependence (within the past six months)
- active psychosis
- Bipolar I and II disorders
- neurocognitive impairment and/or a current diagnosis of dementia
- lack of independent housing
- previous participation in a CBT-I program
- employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Memorial Hospital/Infectious Disease Program
Atlanta, Georgia, 30303
About this study
Official title: A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.
Read the detailed description
The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.
- Being tested
- CBT-I Treatment Condition, SH Comparison Condition
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-I Treatment ConditionBehavioural
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
SH Comparison ConditionBehavioural
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I Treatment Condition | Experimental | The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition. Receives: Behavioral: CBT-I Treatment Condition |
| SH Comparison Condition | Active comparator | The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition. Receives: Behavioral: SH Comparison Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Symptoms
Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.
Measured: baseline, up to 5 weeks post-intervention
Secondary outcomes (2)
Quality of Life
Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition.
Measured: baseline, up to 5 weeks post-intervention
Blood Sample
Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.
Measured: baseline, up to 5 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 Emory 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Shahane, Emory University
- Investigators
- Amit Shahane, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259101
- Sponsor's protocol ID
- IRB00065796
- Status last verified
- May 2016
- First submitted
- 2 Oct 2014
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
- ClinicalTrials.gov ID
- NCT02259101
- Acronym / sponsor ID
- IRB00065796
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Oct 2014 (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 proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.
Detailed description
The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I Treatment Condition | Experimental | Behavioral: CBT-I Treatment ConditionThe CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition. |
| SH Comparison Condition | Active comparator | Behavioral: SH Comparison ConditionThe SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking individuals
- over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
- study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
- must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
- the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
Key exclusion criteria (7 listed)
- current substance dependence (within the past six months)
- active psychosis
- Bipolar I and II disorders
- neurocognitive impairment and/or a current diagnosis of dementia
- lack of independent housing
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 |
|---|---|---|
| CBT-I Treatment ConditionEach group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses. | Behavioural | CBT-I Treatment Condition |
| SH Comparison ConditionEach group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses. | Behavioural | SH Comparison Condition |
Primary outcome
Insomnia Symptoms
Time frame: baseline, up to 5 weeks post-intervention
Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.
2 secondary outcomes
Quality of Life
Time frame: baseline, up to 5 weeks post-intervention
Blood Sample
Time frame: baseline, up to 5 weeks post-intervention
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 6 May 2016.
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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.
Amit Shahane, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I Treatment Condition and SH Comparison Condition in people with Insomnia and HIV, run by Emory 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 6 inclusion and 7 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 6 May 2016. 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 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?
Insomnia Symptoms (time frame: baseline, up to 5 weeks post-intervention). 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 6 May 2016.