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Completed

NCT Number: NCT00523081

Study of Adolescence and Depression

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12-18
  • Current diagnosis of Major Depressive Disorder

Exclusion criteria

  • Psychosis
  • Bipolar
  • Taking anti-depressant medication
  • Significant intellectual impairment
  • Recent treatment with cognitive behavioral therapy

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Active Control

Behavioral

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.

Primary outcomes

  1. The two Primary outcomes are (a) recovery of response from the index episode of major depression and (b) improvements in continuous depression symptomatology .

    Time frame: Assessment at 1 3, 6,12, 18 and 24 months,

Secondary outcomes

  1. Secondary outcomes include depression response; rates of new, recurrent episodes of MDD during follow-up; improvement in psychosocial function; clinical improvements; and reduction in depression-related dysfunction.

    Time frame: Assessment at 1 3, 6,12, 18 and 24 months,

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Brief, Primary Care Cognitive Behavioral Therapy (CBT) for Unmedicated Youth

Acronym: STAND

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Aug 30, 2007
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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