Major Depressive DisorderPhase 2/3SCIPT-ANCT01443715
A Stepped Care Model of Adolescent Depression Treatment in Primary Care
A Phase 2/3 study testing Stepped Care IPT-A (SCIPT-A) and Treatment as Usual in people with Major Depressive Disorder and Dysthymia, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
It is challenging for depressed adolescents and their families to access specialized mental health services. A viable option is delivering treatment in the primary care clinic (PCC) setting; however, few effective models are currently available. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Major Depressive Disorder, Dysthymia
- What is being tested?
- Stepped Care IPT-A (SCIPT-A) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2014
- Phase
- Phase 2/3
- 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females ages 13-20 years
- English and Spanish speaking adolescent
- Parent may be monolingual or bilingual in Spanish
- DSM-IV diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder Not Otherwise Specified
- Moderate impairment in functioning
- Moderate depression severity
- Willing to refrain from other medications unless provided by investigator or PCP during the study
Who cannot join
- Diagnoses of Post Traumatic Stress Disorder , Obsessive Compulsive Disorder, current Substance abuse, Schizophrenia, bipolar disorder, Conduct disorder, Active eating disorder, Pervasive Developmental Disorder, Autism, Asberger's, Psychosis
- Engagement in severe self-injurious behavior in past 3 months
- Active suicidal ideation with plan or intent
- Mental retardation or severe learning disability
- Medical illness that may interfere with treatment
- Open Administration for Children's Services (ACS) case
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- Pregnancy
- Already receiving psychotherapy or medication treatment for depression or have begun a medication trial for another diagnosis within the previous three months
- History of intolerance to fluoxetine or escitalopram
- Failed 2 completely adequate and documented Antidepressant trials
- Co-morbid Attention Deficit Hyperactivity Disorder if not on stable dose of stimulants
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
It is challenging for depressed adolescents and their families to access specialized mental health services. A viable option is delivering treatment in the primary care clinic (PCC) setting; however, few effective models are currently available. The overall aim of this study is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a novel collaborative stepped care model of treatment for depressed adolescents.
Read the detailed description
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression. This stepped care model (SCIPT-A) first delivers a low intensity 6 session plus two parent session adaptation of IPT-A, a treatment designed for mild to moderate adolescent depression with impairment. The second phase in the model is for adolescents with persistent depressive symptoms who will receive 8 more sessions of IPT-A in combination with the addition of an antidepressant. The social worker clinicians (SW) currently employed in the PCC will be trained to deliver the Brief Interpersonal Psychotherapy for adolescents (BIPT-A)and in the second phase, the pediatrician will provide the medication treatment in collaboration with the SW clinician continuing to provide IPT-A. Fifty adolescents identified by their primary care pediatrician and meeting criteria for DSM-IV major depression, dysthymic disorder, or depression, not otherwise specified will be randomized to receive either treatment as usual (TAU) or the SCIPT-A model of stepped collaborative depression care in the PCC for 16 weeks. TAU consists of pediatrician referral of depressed adolescents to either a psychologist, social worker or child psychiatrist within the clinic or to another mental health agency in the community. All adolescents will be administered clinical interviews and self-report questionnaires during the 16 week protocol to assess treatment acceptability, feasibility, safety and preliminary change in symptoms. The project will provide information concerning the feasibility and acceptability of this treatment model for adolescent depression delivered by pediatricians and social work clinicians in pediatric primary care practice.
- Conditions
- Major Depressive Disorder, Dysthymia
- Being tested
- Stepped Care IPT-A (SCIPT-A), Treatment as Usual
- Keywords
- MDD, Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Care IPT-A (SCIPT-A)Behavioural
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression.
Treatment as UsualBehavioural
Standard treatment in the community
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care IPT-A - Interpersonal Psychotherapy | Experimental | IPT-A focuses on communication and problem-solving skills. Receives: Behavioral: Stepped Care IPT-A (SCIPT-A) |
| Treatment as Usual | Active comparator | Treatment as Usual is the standard treatment received in the community Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on proportionality
The investigators will demonstrate the feasibility of the model by calculating the proportion of: 1) adolescent who attend SCIPT-A sessions, 2) adolescents stepped to Phase II who attend their pediatric appointments for medication management, 3) adolescents in Phase II who accepted and followed the medication treatment recommendation, 4) social workers' who were willing and able to learn the SCIPT-A model as demonstrated by displaying fidelity to the treatment model.
Measured: Up to 16 weeks
Secondary outcomes (1)
The proportion of adolescents who agree to be randomized and enrolled in the study protocol
Acceptability of randomization will be determined by the proportion of adolescents from the total eligible who agree to be randomized and enrolled in the study protocol.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Mufson, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443715
- Sponsor's protocol ID
- 6432
- Other IDs
- 1R34MH091320-01A1
- Acronym
- SCIPT-A
- Status last verified
- Apr 2013
- First submitted
- 28 Sep 2011
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Care Model of Adolescent Depression Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT01443715
- Acronym / sponsor ID
- SCIPT-A / 6432
- Conditions
- Major Depressive Disorder, Dysthymia
- Keywords
- MDD, Dysthymia, Depressive Disorder Not Otherwise Specified (DDNOS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Sep 2011 (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.
It is challenging for depressed adolescents and their families to access specialized mental health services. A viable option is delivering treatment in the primary care clinic (PCC) setting; however, few effective models are currently available. The overall aim of this study is to assess in the pediatric PCC, the preliminary acceptability and feasibility of a novel collaborative stepped care model of treatment for depressed adolescents.
Detailed description
Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression. This stepped care model (SCIPT-A) first delivers a low intensity 6 session plus two parent session adaptation of IPT-A, a treatment designed for mild to moderate adolescent depression with impairment. The second phase in the model is for adolescents with persistent depressive symptoms who will receive 8 more sessions of IPT-A in combination with the addition of an antidepressant. The social worker clinicians (SW) currently employed in the PCC will be trained to deliver the Brief Interpersonal Psychotherapy for adolescents (BIPT-A)and in the second phase, the pediatrician will provide the medication treatment in collaboration with the SW clinician continuing to provide IPT-A. Fifty adolescents identified by their primary care pediatrician and meeting criteria for DSM-IV major depression, dysthymic disorder, or depression, not otherwise specified will be randomized to receive either treatment as usual (TAU) or the SCIPT-A model of stepped collaborative depression care in the PCC for 16 weeks. TAU consists of pediatrician referral of depressed adolescents to either a psychologist, social worker or child psychiatrist within the clinic or to another mental health agency in the community. All adolescents will be administered clinical interviews and self-report questionnaires during the 16 week protocol to assess treatment acceptability, feasibility, safety and preliminary change in symptoms. The project will provide information concerning the feasibility and acceptability of this treatment model for adolescent depression delivered by pediatricians and social work clinicians in pediatric primary care practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care IPT-A - Interpersonal Psychotherapy | Experimental | Behavioral: Stepped Care IPT-A (SCIPT-A)IPT-A focuses on communication and problem-solving skills. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as Usual is the standard treatment received in the community |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Males and females ages 13-20 years
- English and Spanish speaking adolescent
- Parent may be monolingual or bilingual in Spanish
- DSM-IV diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder Not Otherwise Specified
- Moderate impairment in functioning
Key exclusion criteria (11 listed)
- Diagnoses of Post Traumatic Stress Disorder , Obsessive Compulsive Disorder, current Substance abuse, Schizophrenia, bipolar disorder, Conduct disorder, Active eating disorder, Pervasive Developmental Disorder, Autism, Asberger's, Psychosis
- Engagement in severe self-injurious behavior in past 3 months
- Active suicidal ideation with plan or intent
- Mental retardation or severe learning disability
- Medical illness that may interfere with treatment
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 |
|---|---|---|
| Stepped Care IPT-A (SCIPT-A)Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression. | Behavioural | Stepped Care IPT-A - Interpersonal Psychotherapy |
| Treatment as UsualStandard treatment in the community | Behavioural | Treatment as Usual |
Primary outcome
Feasibility based on proportionality
Time frame: Up to 16 weeks
The investigators will demonstrate the feasibility of the model by calculating the proportion of: 1) adolescent who attend SCIPT-A sessions, 2) adolescents stepped to Phase II who attend their pediatric appointments for medication management, 3) adolescents in Phase II who accepted and followed the medication treatment recommendation, 4) social workers' who were willing and able to learn the SCIPT-A model as demonstrated by displaying fidelity to the treatment model.
1 secondary outcome
The proportion of adolescents who agree to be randomized and enrolled in the study protocol
Time frame: Up to 16 weeks
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 4 Sep 2014.
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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.
Laura Mufson, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stepped Care IPT-A (SCIPT-A) and Treatment as Usual in people with Major Depressive Disorder and Dysthymia, run by New York State Psychiatric Institute 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 7 inclusion and 11 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 4 Sep 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Feasibility based on proportionality (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2014.