DepressionPhase 2NCT00270244
Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics
A Phase 2 study testing Group interpersonal psychotherapy for depressed adolescents (IPT-AG) and Treatment as usual (TAU) in people with Depression, run by New York State Psychiatric Institute.
Trial summary
This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Group interpersonal psychotherapy for depressed adolescents (IPT-AG) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jan 2008
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score of 24 or greater on the CES-D
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking
- Parental or legal guardian consent to participate
Who cannot join
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Any life threatening medical illness
- Meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder
- Any evidence of psychosis, conduct disorder, or active eating disorder
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- Currently in active treatment for depression
- Taking antidepressant medication at the time of baseline assessment
- Recent death of someone close
About this study
Official title: Group Interpersonal Psychotherapy for Depressed Adolescents (IPT-AG) in School-based Clinics
This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics.
Read the detailed description
Depression is a serious medical condition. It occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. Children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. A previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving depressive symptoms of adolescents in school-based health clinics.
Participants in this 16-week single-blind study will be randomly assigned to receive either IPT-AG or TAU in a school-based clinic. Participants assigned to receive IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. Study visits will occur at baseline and Weeks 4, 8, 12, and 16, or upon early termination. At the end of 16 weeks, participants assigned to receive IPT-AG will continue in a maintenance program in which they will receive IPT-AG once a month for an additional 6 months. All participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.
- Conditions
- Depression
- Being tested
- Group interpersonal psychotherapy for depressed adolescents (IPT-AG), Treatment as usual (TAU)
- Keywords
- Major Depression, Dysthymic Disorder, Adjustment Disorder With Depressed Mood, Depressive Disorder Not Otherwise Specified, Adolescent, Psychotherapy
- Medical subject headings
- Depression, Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interpersonal psychotherapy for depressed adolescents (IPT-AG)Behavioural
Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships.
Treatment as usual (TAU)Behavioural
TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment as usual (TAU) |
| 2 | Experimental | Participants will receive group interpersonal psychotherapy for depressed adolescents Receives: Behavioral: Group interpersonal psychotherapy for depressed adolescents (IPT-AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D)
Measured: Measured at Month 18
Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS)
Measured: Measured at Month 18
Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR)
Measured: Measured at Month 18
Secondary outcomes (1)
Short Acculturation Scale for Hispanics, CES-D, HRSD, C-GAS, Clinical Global Improvement, Inventory of Parent and Peer Attachment, Family Adaptation and Cohesions Evaluation Scales III, and the Penn Helping Alliance Questionnaire-Revised
Measured: Measured at Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Laura H. Mufson, PhD, Principal investigator, New York State Psychiatric Institute-Columbia University College of Physicians and Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270244
- Sponsor's protocol ID
- R01 MH73640, #5037
- Other IDs
- R01MH073640, DSIR 84-CTS
- Status last verified
- Dec 2011
- First submitted
- 21 Dec 2005
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Interpersonal Psychotherapy for Depressed Adolescents (IPT-AG) in School-based Clinics
- ClinicalTrials.gov ID
- NCT00270244
- Acronym / sponsor ID
- R01 MH73640, #5037
- Conditions
- Depression
- Keywords
- Major Depression, Dysthymic Disorder, Adjustment Disorder With Depressed Mood, Depressive Disorder Not Otherwise Specified, Adolescent, Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Dec 2005 (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.
This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics.
Detailed description
Depression is a serious medical condition. It occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. Children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. A previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving depressive symptoms of adolescents in school-based health clinics.
Participants in this 16-week single-blind study will be randomly assigned to receive either IPT-AG or TAU in a school-based clinic. Participants assigned to receive IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. Study visits will occur at baseline and Weeks 4, 8, 12, and 16, or upon early termination. At the end of 16 weeks, participants assigned to receive IPT-AG will continue in a maintenance program in which they will receive IPT-AG once a month for an additional 6 months. All participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual |
| 2 | Experimental | Behavioral: Group interpersonal psychotherapy for depressed adolescents (IPT-AG)Participants will receive group interpersonal psychotherapy for depressed adolescents |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score of 24 or greater on the CES-D
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking
Key exclusion criteria (9 listed)
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Any life threatening medical illness
- Meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder
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 |
|---|---|---|
| Group interpersonal psychotherapy for depressed adolescents (IPT-AG)Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships. | Behavioural | 2 |
| Treatment as usual (TAU)TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. | Behavioural | 1 |
Primary outcome
Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: Measured at Month 18
Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS)
Time frame: Measured at Month 18
Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR)
Time frame: Measured at Month 18
1 secondary outcome
Short Acculturation Scale for Hispanics, CES-D, HRSD, C-GAS, Clinical Global Improvement, Inventory of Parent and Peer Attachment, Family Adaptation and Cohesions Evaluation Scales III, and the Penn Helping Alliance Questionnaire-Revised
Time frame: Measured at Month 18
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 30 Dec 2011.
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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 H. Mufson, PhD principal investigator
New York State Psychiatric Institute-Columbia University College of Physicians and Surgeons
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group interpersonal psychotherapy for depressed adolescents (IPT-AG) and Treatment as usual (TAU) in people with Depression, run by New York State Psychiatric Institute.
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 6 inclusion and 9 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D) (time frame: Measured at Month 18). The study lists 3 primary outcomes in all. 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 30 Dec 2011.