Major Depressive Disorder Clinical Trial
Official title:
Brief, Primary Care Cognitive Behavioral Therapy (CBT) for Unmedicated Youth
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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