Study of Adolescence and Depression (STAND)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00523081
First received: August 29, 2007
Last updated: January 30, 2014
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Active control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief, Primary Care Cognitive Behavioral Therapy (CBT) for Unmedicated Youth

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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, ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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, ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: October 2006
Study Completion Date: January 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Teens in the experimental group will meet with a research counselor for five to nine individual, 50-minute weekly sessions. They will learn ways to deal with stress and feel better. The study counselor will also talk to the teen's doctor from time to time to help plan for the best possible care.
Behavioral: Cognitive Behavioral Therapy (CBT)
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 Comparator: Active Control Behavioral: Active control
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00523081

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Greg N Clarke, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00523081     History of Changes
Other Study ID Numbers: R01 MH073918-01A1, R01MH073918-01A1
Study First Received: August 29, 2007
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
adolescent depression treatment, cognitive behavioral therapy,
collaborative care

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014