DepressionPhase 1NCT00509340
Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
A Phase 1 study testing Cognitive behavioral therapy (CBT) in people with Depression and HIV Infection, run by RAND at 1 site in United States.
Trial summary
This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, HIV Infection
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
- Currently taking ART for HIV infection
- Less than 90% adherence rate to ART regimen
- Capable of walking and in stable health
- Speaks fluent English
Who cannot join
- Depression therapy is needed immediately
- Meets criteria for current drug dependency
- Current diagnosis of psychotic disorder or bipolar depression
Trial locations and contacts
1 site in 1 country.
United States1 site
LA Biomedical Institute at Harbor-UCLA
Torrance, California
About this study
Official title: Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.
Read the detailed description
Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.
This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.
- Conditions
- Depression, HIV Infection
- Being tested
- Cognitive behavioral therapy (CBT)
- Keywords
- antiretroviral, adherence, poor antiretroviral adherence
- Medical subject headings
- Depression, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Participants will receive usual clinical care, which may or may not include mental health treatment |
| 2 | Experimental | Participants will receive cognitive behavioral intervention Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microelectronic medication adherence
Measured: Measured at Weeks 16 and 24
Secondary outcomes (1)
Self-reported depression
Measured: Measured at Weeks 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Inability to recruit enough eligible participants at study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Glenn Wagner, RAND
- Investigators
- Glenn J. Wagner, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509340
- Sponsor's protocol ID
- R34MH077503
- Other IDs
- R34MH077503, DAHBR 9A-ASNM
- Status last verified
- Jun 2013
- First submitted
- 30 Jul 2007
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
- ClinicalTrials.gov ID
- NCT00509340
- Acronym / sponsor ID
- R34MH077503
- Conditions
- Depression, HIV Infection
- Keywords
- antiretroviral, adherence, poor antiretroviral adherence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit enough eligible participants at study site.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Jul 2007 (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.
This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.
Detailed description
Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.
This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Participants will receive usual clinical care, which may or may not include mental health treatment |
| 2 | Experimental | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive cognitive behavioral intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
- Currently taking ART for HIV infection
- Less than 90% adherence rate to ART regimen
- Capable of walking and in stable health
- Speaks fluent English
Key exclusion criteria (3 listed)
- Depression therapy is needed immediately
- Meets criteria for current drug dependency
- Current diagnosis of psychotic disorder or bipolar depression
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 (CBT)Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression. | Behavioural | 2 |
Primary outcome
Microelectronic medication adherence
Time frame: Measured at Weeks 16 and 24
1 secondary outcome
Self-reported depression
Time frame: Measured at Weeks 16 and 24
Results and safety
The study was stopped early (reason given: Inability to recruit enough eligible participants at study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
Glenn J. Wagner, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive behavioral therapy (CBT) in people with Depression and HIV Infection, run by RAND 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 3 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 21 Jun 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit enough eligible participants at study site.). 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?
Microelectronic medication adherence (time frame: Measured at Weeks 16 and 24). 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 21 Jun 2013.