Depressive Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.
Interventions
OTHERUsual Care
Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI
IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.
Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
Sponsors
National Institute of Mental Health (NIMH)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC * Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised \[CDRS-R\]) * Current impairment in psychosocial functioning (based on Children's Global Assessment Scale \[CGAS\])
Exclusion criteria
* Non English-speaking * Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder. * Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study. * Currently taking medication for a psychiatric diagnosis other than ADHD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Depression Rating Scale - Revised | 16 weeks | Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Global Assessment Scale | 16 weeks | Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IPT-A Adaptive Treatment Strategy Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).
Interpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.
Selective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline | 57 |
| Usual Care Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.
Usual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI | 33 |
| Total | 90 |
Baseline characteristics
| Characteristic | IPT-A Adaptive Treatment Strategy | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 33 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.8 years STANDARD_DEVIATION 1.6 | 14.2 years STANDARD_DEVIATION 2 | 14.6 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 24 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 43 Participants | 24 Participants | 67 Participants |
| Region of Enrollment United States | 57 participants | 33 participants | 90 participants |
| Sex: Female, Male Female | 41 Participants | 21 Participants | 62 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 33 |
| other Total, other adverse events | 10 / 57 | 5 / 33 |
| serious Total, serious adverse events | 0 / 57 | 0 / 33 |
Outcome results
Primary
Children's Depression Rating Scale - Revised
Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPT-A Adaptive Treatment Strategy | Children's Depression Rating Scale - Revised | 36.0 score on a scale | Standard Deviation 11.3 |
| Usual Care | Children's Depression Rating Scale - Revised | 37.5 score on a scale | Standard Deviation 11.7 |
p-value: 0.7695% CI: [-6.56, 4.7]Regression, Linear
Secondary
Children's Global Assessment Scale
Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPT-A Adaptive Treatment Strategy | Children's Global Assessment Scale | 61.8 score on a scale | Standard Deviation 9.5 |
| Usual Care | Children's Global Assessment Scale | 63.3 score on a scale | Standard Deviation 12.1 |
p-value: 0.3295% CI: [-7.42, 2.3]Regression, Linear