Treatment for Depression Among HIV-Infected Youth
Condition: HIV; Depression; HIV Infections
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    


Intervention name(s): COMB - Combination Cognitive Behavioral Therapy and Medication Management; TAU - Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Cognitive Behavioral Therapy (CBT); Medication Management (MM)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: youth; HIV; Depression; Cognitive Behavioral Therapy; Medication management