HIVNCT00951028
Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
A study testing Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD), Life-steps adherence treatment and Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD) in people with HIV and Depression, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Depression, HIV Infections
- What is being tested?
- Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD), Life-steps adherence treatment and Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2008to Apr 2013
- 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
- HIV-infected
- Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions [CGI] scale score of 2 or greater)
- Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months
Who cannot join
- Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
- Diagnosis with any primary psychotic disorder, even if treated
- Treatment with CBT within the past year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Fenway Community Health Center
Boston, Massachusetts, 02215
Butler Hospital
Providence, Rhode Island, 02906
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: Efficacy of CBT for Adherence and Depression in HIV Care Settings
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
Read the detailed description
People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.
Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.
Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).
- Conditions
- HIV, Depression, HIV Infections
- Being tested
- Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD), Life-steps adherence treatment, Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)
- Keywords
- 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) for adherence and depression (CBT-AD)Behavioural
12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications
Life-steps adherence treatmentBehavioural
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)Behavioural
12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced treatment as usual | Active comparator | Participants will receive the life-steps intervention and treatment as usual. Receives: Behavioral: Life-steps adherence treatment |
| CBT for adherence and depression (CBT-AD) | Experimental | Participants will receive the life-steps and CBT-AD interventions. Receives: Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD); Behavioral: Life-steps adherence treatment |
| ISP for adherence and depression (ISP-AD) | Active comparator | Participants will receive the life-steps and ISP-AD interventions. Receives: Behavioral: Life-steps adherence treatment; Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.
Measured: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months
Secondary outcomes (5)
changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor
Measured: Measured at baseline and after 4, 8, and 12 months
changes in depression, as measured by the blinded assessor CGI rating
Measured: Measured at baseline and after 4, 8, and 12 months
changes in RNA viral load
Measured: Measured at baseline and after 4, 8, and 12 months
changes in CD4 cell count
Measured: Measured at baseline and after 4, 8, and 12 months
changes in self-reported depression (CESD)
This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments.
Measured: Measured at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven A. Safren, Massachusetts General Hospital
- Investigators
- Steven A. Safren, PhD, Principal investigator, Partners HealthCareC. Andres Bedoya, PhD, Study director, Partners HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951028
- Sponsor's protocol ID
- R01MH084757
- Other IDs
- R01MH084757, 1R01MH084757-01A1, DAHBR 9A-ASGA
- Status last verified
- Jun 2013
- First submitted
- 3 Aug 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CBT for Adherence and Depression in HIV Care Settings
- ClinicalTrials.gov ID
- NCT00951028
- Acronym / sponsor ID
- R01MH084757
- Conditions
- HIV, Depression, HIV Infections
- Keywords
- Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Aug 2009 (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 test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
Detailed description
People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.
Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.
Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced treatment as usual | Active comparator | Behavioral: Life-steps adherence treatmentParticipants will receive the life-steps intervention and treatment as usual. |
| CBT for adherence and depression (CBT-AD) | Experimental | Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD), Behavioral: Life-steps adherence treatmentParticipants will receive the life-steps and CBT-AD interventions. |
| ISP for adherence and depression (ISP-AD) | Active comparator | Behavioral: Life-steps adherence treatment, Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)Participants will receive the life-steps and ISP-AD interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected
- Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions [CGI] scale score of 2 or greater)
- Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months
Key exclusion criteria (3 listed)
- Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
- Diagnosis with any primary psychotic disorder, even if treated
- Treatment with CBT within the past 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 |
|---|---|---|
| Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications | Behavioural | CBT for adherence and depression (CBT-AD) |
| Life-steps adherence treatmentSingle-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management | Behavioural | CBT for adherence and depression (CBT-AD), Enhanced treatment as usual, ISP for adherence and depression (ISP-AD) |
| Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications. | Behavioural | ISP for adherence and depression (ISP-AD) |
Primary outcome
changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
Time frame: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months
HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.
5 secondary outcomes
changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor
Time frame: Measured at baseline and after 4, 8, and 12 months
changes in depression, as measured by the blinded assessor CGI rating
Time frame: Measured at baseline and after 4, 8, and 12 months
changes in RNA viral load
Time frame: Measured at baseline and after 4, 8, and 12 months
changes in CD4 cell count
Time frame: Measured at baseline and after 4, 8, and 12 months
changes in self-reported depression (CESD)
Time frame: Measured at each visit
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 18 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.
Steven A. Safren, PhD principal investigator
Partners HealthCare
C. Andres Bedoya, PhD study director
Partners HealthCare
4 sites 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 (CBT) for adherence and depression (CBT-AD), Life-steps adherence treatment and Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD) in people with HIV and Depression, run by Massachusetts General Hospital at 4 sites 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 3 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: finished, as of the sponsor's last update on 18 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 4 sites 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?
changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores (time frame: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 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 18 Jun 2013.