Treatment for Depression Among HIV-Infected Youth

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01049789
First received: January 13, 2010
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
HIV
Depression
HIV Infections
Behavioral: COMB - Combination Cognitive Behavioral Therapy and Medication Management
Behavioral: TAU - Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment for Depression Among HIV-Infected Youth

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAU
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.
Behavioral: TAU - Treatment as Usual

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.

Experimental: COMB
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.
Behavioral: COMB - Combination Cognitive Behavioral Therapy and Medication Management

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.

Other Names:
  • Cognitive Behavioral Therapy (CBT)
  • Medication Management (MM)

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049789

Locations
United States, Florida
USF College of Medicine
Tampa, Florida, United States, 33606
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Pennsylvania
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Children's Research Center
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Investigators
Study Chair: Larry Brown, MD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01049789     History of Changes
Other Study ID Numbers: ATN 080
Study First Received: January 13, 2010
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
youth
HIV
Depression
Cognitive Behavioral Therapy
Medication management

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014