Major Depressive DisorderPhase 3STANDNCT00523081
Study of Adolescence and Depression
A Phase 3 study testing Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-18
- Current diagnosis of Major Depressive Disorder
Who cannot join
- Psychosis
- Bipolar
- Taking anti-depressant medication
- Significant intellectual impairment
- Recent treatment with cognitive behavioral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT), Active control
- Keywords
- adolescent depression treatment, cognitive behavioral therapy,, collaborative care
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Active Control | Active comparator | Not described Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The two Primary outcomes are (a) recovery of response from the index episode of major depression and (b) improvements in continuous depression symptomatology .
Measured: 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.
Measured: Assessment at 1 3, 6,12, 18 and 24 months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Greg N Clarke, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523081
- Sponsor's protocol ID
- R01MH073918-01A1
- Other IDs
- R01MH073918-01A1
- Acronym
- STAND
- Status last verified
- Jul 2012
- First submitted
- 29 Aug 2007
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29351965
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief, Primary Care Cognitive Behavioral Therapy (CBT) for Unmedicated Youth
- ClinicalTrials.gov ID
- NCT00523081
- Acronym / sponsor ID
- STAND / R01MH073918-01A1
- Conditions
- Major Depressive Disorder
- Keywords
- adolescent depression treatment, cognitive behavioral therapy,, collaborative care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)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. |
| Active Control | Active comparator | Behavioral: Active control |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 12-18
- Current diagnosis of Major Depressive Disorder
Key exclusion criteria (5 listed)
- Psychosis
- Bipolar
- Taking anti-depressant medication
- Significant intellectual impairment
- Recent treatment with cognitive behavioral therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental |
| Active controlTeens 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. | Behavioural | Active Control |
Primary outcome
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,
1 secondary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Derived from this study: PubMed 29351965Dickerson 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.
Related trials for Major Depressive Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg N Clarke, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.