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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
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.
USF College of Medicine
Tampa, Florida, United States
Montefiore Medical Center
The Bronx, New York, United States
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Center
Memphis, Tennessee, United States
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
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
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