Back to resultsTreatment for Depression Among HIV-Infected Youth
Primary Purpose
HIV, Depression, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COMB - Combination Cognitive Behavioral Therapy and Medication Management
TAU - Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring youth, HIV, Depression, Cognitive Behavioral Therapy, Medication management
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- USF College of Medicine
- Montefiore Medical Center
- The Childrens Hospital of Philadelphia
- St. Jude Children's Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU
COMB
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Ph I and II: To examine acceptability of study participation, feasibility of participation in such a study and participant satisfaction with the intervention
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Ph II: Examine whether participants receiving COMB demonstrate improved medical outcomes (e.g., increased CD4 T-cell count, decreased HIV Ribonucleic Acid (RNA) level).
Ph II: Obtain preliminary descriptive data on what TAU consists of for participants with HIV and depression in this age group.
Full Information
NCT ID
NCT01049789
First Posted
January 13, 2010
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01049789
Brief Title
Treatment for Depression Among HIV-Infected Youth
Official Title
Treatment for Depression Among HIV-Infected Youth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Depression, HIV Infections
Keywords
youth, HIV, Depression, Cognitive Behavioral Therapy, Medication management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
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.
Arm Title
COMB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COMB - Combination Cognitive Behavioral Therapy and Medication Management
Other Intervention Name(s)
Cognitive Behavioral Therapy (CBT), Medication Management (MM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU - Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Brown, MD
Organizational Affiliation
Adolescent Trials Network
Official's Role
Study Chair
Facility Information:
Facility Name
USF College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
The Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Children's Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment for Depression Among HIV-Infected Youth
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