Study of Adolescence and Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      STAND is a research study testing a way to help teens between 12-18 years of age who have
      symptoms of sadness or depression. The study hopes to learn if teens do better if they get
      five to nine counseling sessions of cognitive behavioral therapy coordinated with the support
      of their doctor. All teens who join the study will keep seeing their doctor as usual.

      Teens and a parent are interviewed briefly over the phone to see if they are appropriate for
      the study. If they qualify for the study, there is an hour-long interview with teen over the
      telephone and a 30 minute interview with the parent. The interview will include questions
      about the teen's mood, feelings, behavior, and how they get along with friends and family
      members. The parent is also asked about his or her own feelings and mood. If the teen and
      parent join the study, they will be interviewed six more times in the next two years.

      Half the teens in the study will also meet with a research counselor for five to nine
      individual, weekly sessions that last about 50 minutes each. Whether a teen attends the
      weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned
      to these sessions, they will learn ways to deal with stress and feel better. If teens take
      part in the counseling sessions, the study counselor will also talk to the teen's doctor from
      time to time to help plan for the best possible care.
    

Detailed description: 
      Substantial numbers of depressed adolescents either decline antidepressant medication or
      quickly discontinue such medications before benefits are expected. Recent controversies
      regarding the safety of SSRI anti-depressants are likely to increase medication refusal. More
      than half of depressed adolescents identified in primary care prefer psychosocial treatments,
      compared to 20% who prefer medication. Among the psychotherapy alternatives to medication,
      cognitive behavioral therapy (CBT) has the strongest research support.

      The STAND study is a two-arm, randomized, efficacy-effectiveness trial in primarily a Health
      Maintenance Organization (HMO), comparing a treatment as usual (TAU) control condition to TAU
      plus brief, individual, collaborative care CBT delivered in primary care. We will enroll 240
      youth ages 12 to 18 who, during this depressive episode, have either declined anti-depressant
      medication or who received a single dispense of anti-depressant medication but quickly
      discontinued. All enrolled cases will be reassessed periodically throughout a 24-month
      follow-up period. The primary clinical outcome is recovery from the index episode of major
      depression, assessed via research diagnosis. Secondary outcomes include continuous depression
      symptomatology; depression response; rates of new, recurrent episodes of major depression in
      the follow-up period; improvements in psychosocial function; clinical improvement; reduction
      in depression-related dysfunction; parent/youth attitudes regarding treatment. We will also
      examine incremental cost-effectiveness of CBT compared to TAU from the HMO, family, and
      societal perspectives. We will conduct exploratory analyses of mediation and moderation of
      depression treatment outcomes, and employ data from the TAU control condition to estimate the
      usual outcomes for depressed youth who refuse/discontinue antidepressant medication. Finally,
      we will examine how provider, parent and youth barriers, attitudes and beliefs moderate
      outcomes, as well as possibly change over time as a function of participation in this
      program.

      The validation of a primary care model for brief CBT may prove to be a significant benefit to
      the sizeable numbers of depressed youth identified in primary care, and who elect not to try
      anti-depressant medication or quickly discontinue an initial trial.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Active control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Half the teens in the study will also meet with a research counselor for five to nine individual, weekly sessions that last about 50 minutes each. Whether a teen attends the weekly counseling sessions is decided by chance, like flipping a coin. If teens are assigned to these sessions, they will learn ways to deal with stress and feel better. If teens take part in the counseling sessions, the study counselor will also talk to the teen's doctor from time to time to help plan for the best possible care.; Teens in the active control arm will keep seeing their doctor as usual. Teens and a parent are interviewed briefly over the phone to see if they are appropriate for the study. If they qualify for the study, there is an hour-long interview with teen over the telephone and a 30 minute interview with the parent. They will be interviewed six more times in the next two years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent depression treatment, cognitive behavioral therapy,; collaborative care