HIVNCT01049789
Treatment for Depression Among HIV-Infected Youth
A study testing COMB - Combination Cognitive Behavioral Therapy and Medication Management and TAU - Treatment as Usual in people with HIV and Depression, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB)… Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV, Depression, HIV Infections
- What is being tested?
- COMB - Combination Cognitive Behavioral Therapy and Medication Management and TAU - Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Oct 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults ages 16 years and 0 days to 24 years and 364 days at time of enrollment;
- Engaged in care at the participating AMTU;
- Documented HIV infection by medical record review or verbal verification from referring professional and aware of their HIV status;
- Primary diagnosis of non-psychotic depression, either MDD, Depression NOS, or Dysthymia, as defined by DSM-IV criteria and as documented prior to study screening by treating licensed mental health clinician;
- Current depressive symptoms warranting intervention as determined by treating licensed mental health clinician with a score of ≥ 7 on the QIDS-C; NOTE: Youth already receiving treatment for depression with QIDS-C scores ≥ 7 are eligible but those with scores < 7, indicating who minimal ongoing depressive symptoms, are not eligible.
- Ability to understand written and spoken English; and
- Ability and willingness to provide informed consent or assent.
Who cannot join
- Known or self-reported by participant to have a history of any psychotic disorder (including depression with psychotic features) and/or bipolar I or II disorder;
- Alcohol or substance dependence based on DSM-IV criteria within the past six months as determined by treating licensed mental health clinician. Any cases that are uncertain require Protocol Team approval;
- Pregnant or breast-feeding females;
- Known or self-reported by participant (or parent if available) to have a first degree relative(s) with Bipolar I Disorder;
- Depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others as determined by treating licensed mental health clinician;
- Cognitive limitations, emotional instability or medical illness as determined by treating licensed mental health clinician and/or study coordinator; and
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- For Phase II only, previous participation in Phase I.
- For participants at COMB sites only, ongoing CBT for treatment of depressive symptoms at time of study enrollment (e.g., teaching cognitive restructuring using role-play, identification of cognitive distortions, automatic thoughts, dysfunctional attitudes); and NOTE: Youth who received CBT in the past may be considered for enrollment. Any cases that are uncertain require Protocol Team approval.
- For participants at COMB sites only, continuing antidepressant management by a site clinician who is not trained in COMB.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Jude Children's Research Center
Memphis, Tennessee, 38105
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
USF College of Medicine
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
About this study
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group.
Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I.
Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM manuals at the end of Phase II.
- Conditions
- HIV, Depression, HIV Infections
- Being tested
- COMB - Combination Cognitive Behavioral Therapy and Medication Management, TAU - Treatment as Usual
- Keywords
- youth, HIV, Depression, Cognitive Behavioral Therapy, Medication management
- 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.
COMB - Combination Cognitive Behavioral Therapy and Medication ManagementBehavioural
Also called Cognitive Behavioral Therapy (CBT), Medication Management (MM)
Phase I: 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals. Study coordinators and site clinicians will document depression symptoms and treatment regimens for all participants for 24 weeks. Site staff and participants at COMB sites will participate in an exit interview and findings will be used to revise CBT and MM intervention manuals at the end of Phase I.
Phase II: similar procedures as Phase I; COMB sites will implement the revised CBT and MM manuals. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. All Phase II participants will have 2 follow-up visits at weeks 36 and 48.
TAU - Treatment as UsualBehavioural
Phase I: Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two.
Phase II: Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48.
| Study group | Role | What they receive |
|---|---|---|
| TAU | Active comparator | Sites participating in Phase I and Phase II will be randomized to implement this treatment method or the other treatment method. All ATN 080 participants at a site randomized to implement TAU will receive that treatment method. Receives: Behavioral: TAU - Treatment as Usual |
| COMB | Experimental | Sites participating in Phase I and Phase II will be randomized to implement this treatment method or the other treatment method. All ATN 080 participants at a site randomized to implement COMB will receive that treatment method. Receives: Behavioral: COMB - Combination Cognitive Behavioral Therapy and Medication Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph. I: To pilot manuals for CBT and MM for treatment of depression in people ages 16-24 infected with HIV that target symptoms of depression, and motivation for medical and depression treatment, adherence to medical care and wellness behaviors.
Measured: 1 year
Ph I and II: To examine acceptability of study participation, feasibility of participation in such a study and participant satisfaction with the intervention
Measured: 3 years
Ph I: To examine the feasibility of collecting depression treatment data as well as data from other desired outcome measures at COMB and TAU sites.
Measured: 1 year
Ph I and II: To revise the manuals based on feedback received in the Phase I from participants, providers and the examination of analyses of adherence and depressive symptom outcomes.
Measured: 3 years
Ph II: To examine whether participants receiving COMB have improved depression and medical treatment adherence (e.g., more kept medical and mental health visits, fewer treatment dropouts) compared to participants receiving TAU.
Measured: 2 years
Ph II: To examine whether participants receiving COMB demonstrate improved depression outcomes (e.g., decreased depressive symptoms, greater remission rates, and decreased relapse rates) compared to the TAU condition.
Measured: 2 years
Secondary outcomes (4)
Ph I: To examine whether participants receiving COMB) have improved depression and medical treatment adherence (e.g., more kept medical and mental health visits, fewer treatment dropouts) compared to participants receiving TAU.
Measured: 1 year
Ph I: To examine whether participants receiving COMB demonstrate improved depression outcomes (e.g., decreased depressive symptoms, greater remission rates, and decreased relapse rates) compared to participants receiving TAU.
Measured: 1 year
Ph II: Examine whether participants receiving COMB demonstrate improved medical outcomes (e.g., increased CD4 T-cell count, decreased HIV Ribonucleic Acid (RNA) level).
Measured: 2 years
Ph II: Obtain preliminary descriptive data on what TAU consists of for participants with HIV and depression in this age group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2013
- Study completionOct 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 University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Larry Brown, MD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049789
- Sponsor's protocol ID
- ATN 080
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Depression Among HIV-Infected Youth
- ClinicalTrials.gov ID
- NCT01049789
- Acronym / sponsor ID
- ATN 080
- Conditions
- HIV, Depression, HIV Infections
- Keywords
- youth, HIV, Depression, Cognitive Behavioral Therapy, Medication management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jun 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Jan 2010 (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 is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group.
Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I.
Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM manuals at the end of Phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU | Active comparator | Behavioral: TAU - Treatment as UsualSites participating in Phase I and Phase II will be randomized to implement this treatment method or the other treatment method. All ATN 080 participants at a site randomized to implement TAU will receive that treatment method. |
| COMB | Experimental | Behavioral: COMB - Combination Cognitive Behavioral Therapy and Medication ManagementSites participating in Phase I and Phase II will be randomized to implement this treatment method or the other treatment method. All ATN 080 participants at a site randomized to implement COMB will receive that treatment method. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adolescents and young adults ages 16 years and 0 days to 24 years and 364 days at time of enrollment;
- Engaged in care at the participating AMTU;
- Documented HIV infection by medical record review or verbal verification from referring professional and aware of their HIV status;
- Primary diagnosis of non-psychotic depression, either MDD, Depression NOS, or Dysthymia, as defined by DSM-IV criteria and as documented prior to study screening by treating licensed mental health clinician;
- Current depressive symptoms warranting intervention as determined by treating licensed mental health clinician with a score of ≥ 7 on the QIDS-C; NOTE: Youth already receiving treatment for depression with QIDS-C scores ≥ 7 are eligible but those with scores < 7, indicating who minimal ongoing depressive symptoms, are not eligible.
Key exclusion criteria (9 listed)
- Known or self-reported by participant to have a history of any psychotic disorder (including depression with psychotic features) and/or bipolar I or II disorder;
- Alcohol or substance dependence based on DSM-IV criteria within the past six months as determined by treating licensed mental health clinician. Any cases that are uncertain require Protocol Team approval;
- Pregnant or breast-feeding females;
- Known or self-reported by participant (or parent if available) to have a first degree relative(s) with Bipolar I Disorder;
- Depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others as determined by treating licensed mental health clinician;
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 |
|---|---|---|
| COMB - Combination Cognitive Behavioral Therapy and Medication ManagementAlso: Cognitive Behavioral Therapy (CBT), Medication Management (MM)Phase I: 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals. Study coordinators and site clinicians will document depression symptoms and treatment regimens for all participants for 24 weeks. Site staff and participants at COMB sites will participate in an exit interview and findings will be used to revise CBT and MM intervention manuals at the end of Phase I. Phase II: similar procedures as Phase I; COMB sites will implement the revised CBT and MM manuals. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. All Phase II participants will have 2 follow-up visits at weeks 36 and 48. | Behavioural | COMB |
| TAU - Treatment as UsualPhase I: Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Phase II: Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. | Behavioural | TAU |
Primary outcome
Ph. I: To pilot manuals for CBT and MM for treatment of depression in people ages 16-24 infected with HIV that target symptoms of depression, and motivation for medical and depression treatment, adherence to medical care and wellness behaviors.
Time frame: 1 year
Ph I and II: To examine acceptability of study participation, feasibility of participation in such a study and participant satisfaction with the intervention
Time frame: 3 years
Ph I: To examine the feasibility of collecting depression treatment data as well as data from other desired outcome measures at COMB and TAU sites.
Time frame: 1 year
Ph I and II: To revise the manuals based on feedback received in the Phase I from participants, providers and the examination of analyses of adherence and depressive symptom outcomes.
Time frame: 3 years
Ph II: To examine whether participants receiving COMB have improved depression and medical treatment adherence (e.g., more kept medical and mental health visits, fewer treatment dropouts) compared to participants receiving TAU.
Time frame: 2 years
Ph II: To examine whether participants receiving COMB demonstrate improved depression outcomes (e.g., decreased depressive symptoms, greater remission rates, and decreased relapse rates) compared to the TAU condition.
Time frame: 2 years
4 secondary outcomes
Ph I: To examine whether participants receiving COMB) have improved depression and medical treatment adherence (e.g., more kept medical and mental health visits, fewer treatment dropouts) compared to participants receiving TAU.
Time frame: 1 year
Ph I: To examine whether participants receiving COMB demonstrate improved depression outcomes (e.g., decreased depressive symptoms, greater remission rates, and decreased relapse rates) compared to participants receiving TAU.
Time frame: 1 year
Ph II: Examine whether participants receiving COMB demonstrate improved medical outcomes (e.g., increased CD4 T-cell count, decreased HIV Ribonucleic Acid (RNA) level).
Time frame: 2 years
Ph II: Obtain preliminary descriptive data on what TAU consists of for participants with HIV and depression in this age group.
Time frame: 2 years
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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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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.
Larry Brown, MD study chair
Adolescent Trials Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMB - Combination Cognitive Behavioral Therapy and Medication Management and TAU - Treatment as Usual in people with HIV and Depression, run by University of North Carolina, Chapel Hill 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 7 inclusion and 9 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 28 Feb 2017. 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?
Ph. I: To pilot manuals for CBT and MM for treatment of depression in people ages 16-24 infected with HIV that target symptoms of depression, and motivation for medical and depression treatment, adherence to medical care and wellness behaviors. (time frame: 1 year). The study lists 6 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 28 Feb 2017.