Study of Adolescence and Depression

NCT00523081 | Completed Phase 3 DMC

• 1 other identifier: R01MH073918-01A1
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

adolescent depression treatment, cognitive behavioral therapy,; collaborative care

Outcome Measures

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 .

  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.

  Assessment at 1 3, 6,12, 18 and 24 months,

Study Arms (2)

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)

Active Control

ACTIVE COMPARATOR

Behavioral: Active control

Interventions

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.

Experimental

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.

Active Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

• Dickerson JF, Lynch FL, Leo MC, DeBar LL, Pearson J, Clarke GN. Cost-effectiveness of Cognitive Behavioral Therapy for Depressed Youth Declining Antidepressants. Pediatrics. 2018 Feb;141(2):e20171969. doi: 10.1542/peds.2017-1969. Epub 2018 Jan 19.

  PMID: 29351965 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Greg N Clarke, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: January 1, 2014
• Last Updated: February 3, 2014

Record last verified: 2012-07

Locations

US (1)